A method for evaluating the repair of hemorrhoid wounds by recombinant collagen

Abstract

This invention provides a recombinant collagen hemorrhoid wound repair assessment method, relating to the fields of medical technology and medical device efficacy evaluation. The method includes standardized data collection of the target wound at the baseline observation time point according to the data collection specifications. This standardized collection includes collecting wound images containing scale reference information and performing consistency verification, as well as collecting scale data corresponding to the subjective dimensions of the symptoms, forming a baseline dataset. This recombinant collagen hemorrhoid wound repair assessment method, by uniformly setting and solidifying assessment rules and data collection specifications, and combining standardized collection of wound imaging and symptom scales, achieves comparability and consistency of wound repair assessments across individuals and institutions. The strict unified operating procedures ensure a high degree of consistency in wound assessment results across different institutions and patients, improving the scientific rigor and reliability of the assessment.

Description

Technical Field

[0001] This invention relates to the field of medical technology and medical device efficacy evaluation technology, specifically a method for evaluating the repair of hemorrhoid wounds using recombinant collagen. Background Technology

[0002] In existing technologies, wound repair materials are typically applied topically or intracavitarily for the care and adjuvant treatment of hemorrhoid wounds and post-hemorrhoidal wounds. For example, recombinant collagen wound repair gels can be injected into the affected area or applied directly to the wound using a syringe for repairing and caring for hemorrhoid wounds and post-operative wounds, and to help alleviate discomfort symptoms. Meanwhile, to ensure the consistency and basic safety of these gel products, existing technologies generally establish quality control indicators and corresponding testing methods for appearance, dosage, sealing, pH, and microbiology, for factory inspection or registration testing.

[0003] However, the aforementioned existing technologies focus more on outcome-based quality control and are difficult to directly reflect the dynamic changes in wound repair effects after use. The current hemorrhoid wound repair effects often rely on physicians' visual observation and patients' subjective complaints for descriptive judgment, which has problems such as inconsistent evaluation dimensions, strong subjectivity and insufficient repeatability. Furthermore, the lack of a quantitative scoring system, unified observation time points and clear judgment thresholds leads to poor comparability of results between different individuals and institutions, and cannot fully meet the needs of clinical evaluation, R&D optimization and registration evidence for recombinant collagen gel. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides a recombinant collagen hemorrhoid wound repair assessment method. The technical problem this invention aims to solve is: how to address the issues of insufficient standardization, strong subjectivity, and poor comparability of results across individuals and institutions by uniformly setting assessment rules, data collection standards, quantitative grading criteria, and observation time points.

[0005] To achieve the above objectives, the present invention provides the following technical solution: a method for evaluating the repair of hemorrhoid wounds using recombinant collagen, comprising:

[0006] S1. The assessment object is determined to be a hemorrhoid wound or a post-hemorrhoid surgery wound. The evaluated intervention is determined to be the use of recombinant collagen hemorrhoid wound repair gel at the target site. The use includes intracavitary injection and topical application. Before the assessment begins, assessment rules are uniformly set and solidified for consistent execution across individuals and institutions. The assessment rules include: a unified observation time point system, a unified assessment dimension system, quantitative grading standards corresponding to each assessment dimension, a comprehensive judgment standard, and a repair level judgment threshold corresponding to the comprehensive judgment standard. Data collection specifications are uniformly set and solidified. The data collection specifications include wound imaging collection specifications and symptom scale collection specifications. The unified assessment dimension system includes objective wound dimensions and subjective symptom dimensions. The observation time point system includes a baseline time point and subsequent time points. The baseline observation time point is the observation time point before the first administration of recombinant collagen gel to the target wound. The subsequent observation time points are at least one observation time point determined according to a pre-set follow-up observation arrangement after the first administration of recombinant collagen gel to the target wound.

[0007] S2. At the baseline observation time point, the target wound is collected in a standardized manner according to the data collection specifications. The standardized collection includes collecting wound images containing scale reference information and performing consistency verification, as well as collecting scale data corresponding to the subjective dimension of the symptoms to form a baseline dataset.

[0008] S3. At each subsequent observation time point, the standardized data collection was repeated on the same target wound according to the data collection specifications, and consistency verification was performed to form a follow-up dataset.

[0009] S4. Based on the quantitative grading criteria and comprehensive judgment criteria, the baseline dataset and each follow-up dataset are quantitatively processed to obtain quantitative results. The quantitative results include objective dimension quantitative results and subjective symptom grading results. Based on the quantitative results, a comprehensive evaluation result corresponding to each observation time point is generated. The comprehensive evaluation result includes the baseline comprehensive evaluation result and the comprehensive evaluation result of each subsequent observation time point.

[0010] S5. Compare the comprehensive evaluation results of each subsequent observation time point with the baseline comprehensive evaluation results, and output the repair level conclusion of the target wound based on the repair level judgment threshold. Generate a standardized evaluation result that includes the observation time point system, quantitative results, comprehensive evaluation results and repair level conclusion, so as to achieve comparable evaluation between different individuals and different institutions.

[0011] Preferably, the follow-up observation arrangement includes a first follow-up observation time point after the first administration of the recombinant collagen gel to the target wound, and at least one follow-up observation time determined after the completion of the last administration of a pre-set administration course, which is a continuous administration phase for the same target wound that is pre-set and solidified before the start of the evaluation.

[0012] Preferably, the wound imaging acquisition specifications stipulate acquisition methods for different wound locations: for intracavitary wounds, an anoscope camera is used to acquire wound images, and for external perianal wounds, an external imaging device is used to acquire wound images. The scale reference information is a scale mark of the same specification or the calibration scale information of the imaging device, so as to uniformly quantify the objective dimensions of the wound.

[0013] Preferably, the consistency verification includes verifying the consistency of the acquisition conditions of the acquired wound images. The consistency of acquisition conditions includes: consistent acquisition devices, consistent acquisition perspectives, and complete and identifiable scale reference information. When the consistency verification fails, the wound images of the target wound are re-acquired and the consistency verification is re-executed.

[0014] Preferably, the quantitative grading criteria for the objective dimensions of the wound include: identifying the wound boundary based on scale reference information to obtain a quantitative result of the wound range, and grading and recording the wound exudation and bleeding manifestations. The comprehensive judgment criteria generate an objective dimension quantitative result based on the quantitative result of the wound range, the record of wound exudation, and the record of bleeding manifestations.

[0015] Preferably, the scale data is obtained according to a unified scale collection standard, which includes a grading and recording method for the three symptoms of pain, swelling, and post-defecation bleeding. The data is collected using the same scale items and the same grading criteria at the baseline observation time point and at each subsequent observation time point. The quantification result of the subjective dimension of symptoms is the grading result of the subjective dimension of symptoms obtained by converting the scale data collected at the baseline observation time point and each subsequent observation time point according to the quantification grading criteria.

[0016] Preferably, the comprehensive judgment criteria include conflict handling rules. The conflict handling rules stipulate that when the objective dimension quantification results and the subjective dimension grading results of symptoms point to inconsistent repair trends, the comprehensive evaluation results shall be determined primarily based on the objective dimension quantification results of the wound, and the inconsistent situations shall be marked in the standardized evaluation results.

[0017] Preferably, the standardized assessment results are output using a preset report template, which includes assessment object information, target wound location and type information, drug administration method information, wound images at each observation time point, quantitative results, comprehensive evaluation results, and repair level conclusions, in order to support cross-individual and cross-institutional result verification and comparison.

[0018] This invention provides a method for evaluating the repair of hemorrhoidal wounds using recombinant collagen. It has the following beneficial effects:

[0019] This recombinant collagen hemorrhoid wound repair assessment method achieves comparability and consistency of wound repair assessments across individuals and institutions by uniformly setting and solidifying assessment rules and data collection specifications, and by combining standardized collection of wound imaging and symptom scales. The strict and unified operating procedures ensure a high degree of consistency in wound assessment results across different institutions and patients, thereby improving the scientificity and reliability of the assessment.

[0020] A comprehensive assessment method combining objective wound quantification with subjective symptom quantification ensures a complete evaluation, resolves conflicts between different dimensions, prioritizes objective data for judging repair trends, and guarantees the accuracy of assessment conclusions. Standardized report output facilitates result verification and comparison, improving the convenience and reliability of clinical application. Attached Figure Description

[0021] Figure 1 This is an overall flowchart of the method of the present invention;

[0022] Figure 2 This is a flowchart of the data acquisition process for this invention;

[0023] Figure 3 This is a flowchart of the quantification and determination process of this invention. Detailed Implementation

[0024] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0025] Example 1

[0026] like Figure 1-3 As shown, this embodiment of the invention provides a method for evaluating the repair of hemorrhoid wounds using recombinant collagen, comprising:

[0027] S1. The assessment object is determined to be a hemorrhoid wound or a post-hemorrhoid surgery wound. The evaluated intervention is determined to be the application of recombinant collagen hemorrhoid wound repair gel to the target site, including intracavitary injection and topical application. Before the assessment begins, standardized assessment rules are established and solidified for consistent implementation across individuals and institutions. The assessment rules include: a standardized observation time point system, a standardized assessment dimension system, quantitative grading standards corresponding to each assessment dimension, a comprehensive judgment standard, and a repair level judgment threshold corresponding to the comprehensive judgment standard. Standardized data collection specifications are established and solidified. Data collection specifications include wound imaging acquisition specifications and symptom scale acquisition specifications. The standardized assessment dimension system includes objective wound dimensions and subjective symptom dimensions. The observation time point system includes a baseline time point and subsequent time points. The baseline observation time point is the observation time point before the first application of recombinant collagen gel to the target wound. Subsequent observation time points are at least one observation time point determined according to the pre-set follow-up observation arrangement after the first application of recombinant collagen gel to the target wound. The follow-up observation arrangement includes the first follow-up observation point after the initial administration of recombinant collagen gel to the target wound, and at least one follow-up observation point determined after the completion of the last dose of a pre-set treatment course. The treatment course is a pre-set and fixed continuous administration phase targeting the same wound before the assessment begins. Wound imaging acquisition specifications stipulate different acquisition methods for different wound sites: for intracavitary wounds, an anoscope is used to acquire wound images; for external perianal wounds, an external imaging device is used. The scale reference information is a uniform scale marking or the calibration scale information of the imaging device, for the unified quantification of the objective dimensions of the wound. The quantification and grading criteria for the objective dimensions of the wound include: identifying the wound boundary based on the scale reference information to obtain a quantitative result of the wound range; and grading and recording wound exudation and bleeding manifestations. The comprehensive judgment criteria are based on the quantitative result of the wound range, the record of wound exudation, and the record of bleeding manifestations to generate a quantitative result of the objective dimensions. The comprehensive assessment criteria include conflict resolution rules. When the objective dimension quantification results and the subjective dimension grading results of symptoms point to inconsistent repair trends, the comprehensive evaluation results are determined based on the objective dimension quantification results of the wound, and the inconsistencies are marked in the standardized assessment results.

[0028] S2. At the baseline observation time point, standardized data collection was performed on the target wound according to the data collection specifications. Standardized collection included collecting wound images containing scale reference information and performing consistency checks, as well as collecting scale data corresponding to the subjective dimensions of symptoms, forming a baseline dataset. Consistency checks included verifying the consistency of the acquisition conditions of the collected wound images. Consistency of acquisition conditions included: consistent acquisition equipment, consistent acquisition perspective, and complete and identifiable scale reference information. If the consistency check failed, the target wound images were re-acquired and the consistency check was re-performed. Scale data was obtained from a unified scale collection specification, which included the grading and recording methods for the three symptoms of pain, swelling, and post-defecation bleeding. The same scale items and grading standards were used to complete the data collection at the baseline observation time point and each subsequent observation time point. The quantification results of the subjective dimensions of symptoms were obtained by converting the scale data collected at the baseline observation time point and each subsequent observation time point according to the quantified grading standards.

[0029] S3. At each subsequent observation time point, the same target wound is repeatedly sampled in a standardized manner according to the data collection specifications and consistency verification is performed to form a follow-up dataset.

[0030] S4. Based on the quantitative grading criteria and the comprehensive judgment criteria, the baseline dataset and each follow-up dataset are quantitatively processed to obtain quantitative results. The quantitative results include objective dimension quantitative results and subjective symptom grading results. Based on the quantitative results, a comprehensive evaluation result corresponding to each observation time point is generated. The comprehensive evaluation result includes the baseline comprehensive evaluation result and the comprehensive evaluation result of each subsequent observation time point.

[0031] S5. Compare the comprehensive evaluation results at each subsequent observation time point with the baseline comprehensive evaluation results, and output the repair level conclusion of the target wound based on the repair level determination threshold. Generate standardized evaluation results that include the observation time point system, quantitative results, comprehensive evaluation results, and repair level conclusions to achieve comparable evaluations between different individuals and institutions. The standardized evaluation results are output using a preset report template, which includes information on the evaluation object, target wound location and type, administration method, wound images at each observation time point, quantitative results, comprehensive evaluation results, and repair level conclusions to support cross-individual and cross-institutional result verification and comparison.

[0032] This invention ensures the consistency and reliability of assessment results across different individuals and institutions through unified assessment rules and data collection standards. Standardized wound image acquisition and consistency verification measures improve image quality and ensure accurate monitoring of wound changes. The comprehensive assessment system, integrating objective and subjective dimensions, fully reflects the wound repair status, avoiding the limitations of single-dimensional assessments. Standardized assessment results support cross-institutional data verification and comparison, improving the accuracy of the assessment. In cases of conflict between objective and subjective assessment results, this invention prioritizes quantifying results based on objective dimensions, ensuring the fairness and objectivity of the assessment. It is applicable to different types of hemorrhoid wounds or postoperative wounds, possessing strong versatility and adaptability.

[0033] Example 2

[0034] This embodiment evaluates the application effect of recombinant collagen hemorrhoid wound repair gel in postoperative hemorrhoid wound repair based on the recombinant collagen hemorrhoid wound repair assessment method. The specific implementation method is as follows:

[0035] 1. Determine the assessment subjects and intervention methods.

[0036] According to the hospital's clinical treatment records and the patient's medical records, Patient A is a 42-year-old male who underwent surgery for severe internal hemorrhoids. The surgical wound was located around the anus.

[0037] The assessment began on the first day after surgery. Patient A received intervention using recombinant collagen hemorrhoid wound repair gel on the first day after surgery.

[0038] Wound location: Postoperative wound around the anus, with a wound area of ​​4cm², regular wound edges, and a wound depth of approximately 0.5cm. The data are from the patient's postoperative medical records and provide a quantitative basis for the objective assessment of subsequent wound repair.

[0039] Administration method: For the first application, 2 ml of recombinant collagen gel was applied topically. Data was obtained from the patient's treatment records.

[0040] Uniform assessment rules: All patient assessments are conducted strictly in accordance with established assessment rules to ensure consistency across individuals and institutions, and data are based on clinical trial standard operating procedures and treatment protocols.

[0041] 2. Baseline Data Acquisition

[0042] Standardized data collection was performed on the wound of patient A at the baseline observation time point, i.e., the first day after surgery.

[0043] Images of the wound were captured using an anoscope and underwent consistency verification to ensure that the image acquisition conditions were consistent. The data were obtained from the hospital's diagnostic and assessment records.

[0044] Wound image acquisition:

[0045] Wound image quality standards:

[0046] When acquiring images, the resolution of the wound image should be at least 500px × 500px to ensure clear details.

[0047] Standardized anoscope equipment should be used for imaging, and the imaging angle should be direct or conform to the clinical standard anoscope observation angle.

[0048] Lighting conditions should be uniform, with no obvious shadows or reflections affecting image quality.

[0049] The scale reference information should be clearly visible to ensure accurate spatial calibration of the image and facilitate subsequent wound quantification.

[0050] Equipment: Standardized anoscope was used to take images of the wound, with an image size of 500px × 500px, and the images conformed to the equipment standards.

[0051] Image consistency verification: Before taking images of the wound, the physician will calibrate the anoscope to ensure accurate dimensional calibration. Image consistency is reviewed by an experienced physician to ensure consistent shooting angles and complete and clear dimensional reference information in the images. If the image is unsatisfactory, it must be retaken and its consistency confirmed.

[0052] Subjective symptom collection:

[0053] Pain rating:

[0054] Pain rating scale: Pain is rated on a scale of 0-10, where:

[0055] 0 points indicates no pain, 1-3 points indicates mild pain, 4-6 points indicates moderate pain, 7-9 points indicates severe pain, and 10 points indicates excruciating pain that is unbearable.

[0056] The patient rated the pain as 6 out of 10.

[0057] Swelling score:

[0058] Swelling scoring criteria: Swelling is scored on a scale of 0-10, where:

[0059] 0 points indicates no swelling, 1-3 points indicates mild swelling, 4-6 points indicates moderate swelling, 7-9 points indicates severe swelling, and 10 points indicates severe swelling that affects activity.

[0060] Based on the clinical examination results, the patient rated the swelling of the perianal wound as 4 points.

[0061] Post-rectal bleeding score:

[0062] Post-defecation bleeding scoring criteria: Post-defecation bleeding is scored on a scale of 0-10, where:

[0063] 0 points indicates no bleeding, 1-3 points indicates minor bleeding, 4-6 points indicates moderate bleeding, 7-9 points indicates major bleeding, and 10 points indicates severe and continuous bleeding.

[0064] The medical record states that the patient reported minor bleeding after defecation, with a score of 3.

[0065] Wound exudation: Clinical examination showed that the wound exudation was mild, with a small amount of exudate and no overflow. No obvious purulent secretions were observed at the wound site.

[0066] Therefore, the baseline dataset includes the following:

[0067] The wound images were taken using a standardized anoscope, with an image size of 500px × 500px. Subjective symptoms were assessed as follows: pain score of 6, swelling score of 4, post-defecation bleeding score of 3, and mild wound exudation.

[0068] 3. Follow-up data collection

[0069] Patient A continued to receive recombinant collagen gel treatment at 1, 2, and 4 weeks post-surgery and underwent follow-up as planned. All data collection was performed in accordance with the hospital's standardized data collection protocols to ensure successful consistency verification.

[0070] Follow-up data one week later: On the 7th day after surgery, the patient needs to return to the hospital for follow-up.

[0071] Wound image acquisition:

[0072] Equipment: Continue to use standardized anoscope equipment to take images of the wound, with a size of 500px × 500px. Image consistency passed the verification.

[0073] Subjective symptom collection:

[0074] Pain score: The patient reported pain relief, with a score of 4.

[0075] Swelling score: Based on the clinical examination record, the swelling of the wound has been reduced, and the score is 2 points.

[0076] Post-defecation bleeding score: The patient's medical record indicates that post-defecation bleeding has decreased, and the score is 1 point.

[0077] Wound exudation: The amount of wound exudation has decreased, with only slight transparent fluid seeping from the wound. The data is based on clinical examination records.

[0078] Specific data from the follow-up dataset one week later:

[0079] The wound image size is 500px × 500px, and the scale reference information is consistent, which meets the requirements.

[0080] Subjective symptom dimensions: pain score 4 points, swelling score 2 points, post-defecation bleeding score 1 point.

[0081] Changes in wound size: The wound has shrunk to 3cm², with clear wound boundaries, and the wound is healing well.

[0082] Follow-up data two weeks later: that is, the second follow-up was conducted on the 14th day after surgery.

[0083] Wound image acquisition:

[0084] Equipment: Continue to use an anoscope to take images of the wound, 500px × 500px in size, and the image consistency passes the verification.

[0085] Subjective symptom collection:

[0086] Pain score: The patient reported that the pain had been further relieved, and the score was 2 points.

[0087] Swelling score: Based on the clinical examination record, the swelling of the wound has almost subsided, and the score is 1 point.

[0088] Post-defecation bleeding score: The medical record states that the patient reported no bleeding after defecation, and the score is 0.

[0089] Specific data from the follow-up dataset two weeks later:

[0090] Wound image: 500px × 500px, consistent with scale reference information, meets requirements.

[0091] Subjective symptom dimensions: Pain score 2 points, swelling score 1 point, post-defecation bleeding score 0 points.

[0092] Wound exudation: No exudation.

[0093] Changes in wound size: The wound area decreased from 4cm² to 2.5cm², indicating good wound healing and smooth wound repair progress.

[0094] 4. Postoperative follow-up on wound healing

[0095] Wound healing progress: According to postoperative follow-up data, the wound shrank to 3cm² on the 7th postoperative day, a 25% reduction from the baseline. On the 14th postoperative day, the wound shrank to 2.5cm², a further 16.67% reduction from the 7th day.

[0096] At baseline, the wound exudate was 10 ml, which decreased to 5 ml one week post-surgery, and was almost non-exudate two weeks post-surgery.

[0097] Wound depth: The wound depth decreased to 0.3 cm 2 weeks after surgery and gradually became shallower during the wound healing process.

[0098] Follow-up at 3 months post-surgery showed complete wound healing with no recurrence or other complications. The wound was completely closed, and the patient experienced no pain or discomfort; wound recovery was excellent.

[0099] In summary, based on postoperative follow-up data, patient A showed significant wound repair after treatment with recombinant collagen gel. The treatment method promoted postoperative wound repair and has good clinical application prospects.

[0100] Example 3

[0101] This embodiment evaluates the repair effect of recombinant collagen hemorrhoid wound repair gel in the treatment of stage III perianal hemorrhoids using a recombinant collagen hemorrhoid wound repair assessment method. The effectiveness and feasibility of the treatment are verified through standardized quantitative data collection and symptom scoring. The specific implementation method is as follows:

[0102] 1. Patient Information and Treatment Background

[0103] Patient basic information: Patient B is a male, 35 years old, and was diagnosed with stage III perianal hemorrhoids.

[0104] Treatment intervention: Treatment involves using recombinant collagen hemorrhoid wound repair gel for a period of 3 months. During treatment, apply 1g topically once a week, along with maintaining appropriate diet and bowel habits.

[0105] No serious complications occurred during the treatment, but the patient experienced mild discomfort in the anal area during the first two weeks, which was confirmed by the doctor as a common treatment reaction.

[0106] Data collection is conducted through a standardized process, with clinicians collecting data during treatment to ensure the reliability and consistency of the data.

[0107] 2. Baseline Data Acquisition

[0108] Before treatment began, the patient underwent an initial assessment of the wound and symptoms.

[0109] Wound extent measurement: At each time point, images of the wound were captured using an anoscope with a resolution of 1080p, and the scale was clearly visible, ensuring accurate quantification of the wound extent.

[0110] Wound extent: The patient's baseline wound area was 4.2 cm². The wound was imaged using an anoscope, and the scale was confirmed using the calibration information provided by the device.

[0111] Wound exudate assessment:

[0112] Exudate volume: The wound exudate volume was assessed as moderate, and the exudate was pale yellow. The exudate volume was quantified using a standardized assessment form.

[0113] Assessment of bleeding manifestations:

[0114] Bleeding: A small amount of oozing blood is present at the wound site, which is assessed as mild bleeding. The grading is confirmed according to the standard for wound bleeding volume. Mild bleeding is defined as a small amount of fresh blood on the wound surface, without obvious dripping, and only local oozing.

[0115] Symptom score:

[0116] Pain score: 6 / 10. The patient described it as significant pain. The score was based on a standardized pain rating scale.

[0117] Swelling score: 5 / 10, mild swelling, based on the anorectal wound swelling scoring standard.

[0118] Post-defecation bleeding score: 4 / 10, indicating a small amount of bright red bleeding after defecation. The score is based on the clinical assessment criteria for post-defecation bleeding.

[0119] 3. Data collection and evaluation at the first time point

[0120] After one week of treatment, the patient's wound and symptoms showed significant improvement. The assessment results are as follows:

[0121] Wound area: The wound area was reduced to 3.8 cm², and the wound area was remeasured and confirmed using an anoscope.

[0122] Wound exudate: Exudate has decreased to mild exudate, which is transparent or light yellow and meets the criteria for mild exudate. Mild exudate is defined as minimal exudate, with only a localized area being moist.

[0123] Bleeding presentation: The amount of bleeding is still mild, but it has decreased compared to the baseline. The bleeding level is confirmed according to the standardized wound bleeding assessment criteria.

[0124] Symptom score:

[0125] Symptoms were scored on a scale of 0-10, with 0 indicating no symptoms and 10 indicating the most severe symptoms. A pain score of 6 / 10 indicated moderate pain; a swelling score of 5 / 10 indicated mild swelling; and a post-defecation bleeding score of 4 / 10 indicated mild post-defecation bleeding.

[0126] The pain score was 5 / 10, indicating some relief from pain and a reduction in discomfort. The swelling score was 4 / 10, indicating reduced swelling and a decrease in swelling around the anus. The post-defecation bleeding score was 3 / 10, indicating a reduction in post-defecation bleeding compared to baseline.

[0127] 4. Data collection and evaluation at the second time point

[0128] After one month of treatment, the wound has healed significantly, and the assessment results are as follows:

[0129] Wound area: The wound area was further reduced to 2.5 cm², and the wound area was confirmed by measurement using an anoscope.

[0130] Wound exudate: The amount of exudate has been significantly reduced, reduced to mild, and there is almost no exudate, which meets the criteria for mild exudate.

[0131] The amount of exudate was quantified according to the wound exudate standard assessment form and compared with the data from the previous two follow-up assessments, showing a clear healing trend.

[0132] Bleeding manifestations: No bleeding from the wound, bleeding from the wound has completely stopped.

[0133] Symptom score:

[0134] The pain score was 3 / 10, indicating significant pain relief and almost no discomfort for the patient. The swelling score was 2 / 10, indicating significant reduction and almost complete resolution of swelling. The post-defecation bleeding score was 1 / 10, indicating minimal post-defecation bleeding with occasional minor bleeding.

[0135] 5. Data collection and evaluation at the third time point

[0136] Three months after the completion of treatment, the wound had completely healed, and the final assessment results are as follows:

[0137] Wound area: The wound has completely healed, and the wound area is 0 cm².

[0138] The wound healing was finally confirmed using an anoscope. During the recovery period, the patient followed the dietary control recommendations, avoiding spicy and irritating foods, and there were no signs of recurrence.

[0139] Wound exudate: The wound has no exudate at all, the exudate amount is zero, which meets the standard of no exudate.

[0140] Bleeding manifestations: No bleeding from the wound, and complete hemostasis of the wound.

[0141] Symptom score:

[0142] The pain score was 1 / 10, indicating that the pain had almost disappeared and there was only mild discomfort. The swelling score was 1 / 10, indicating that the swelling had almost subsided and the patient reported a return to normal. The post-defecation bleeding score was 0 / 10, indicating that there was no post-defecation bleeding at all.

[0143] 6. Comprehensive evaluation and restoration level determination

[0144] Based on the above quantitative data and symptom scores, and through a comprehensive assessment using both quantitative grading and overall judgment criteria, the following repair level results were obtained:

[0145] The criteria for determining the repair level are as follows:

[0146] A repair level of 3 indicates severely delayed wound healing, with an overall rating of 6 / 10. A repair level of 2 indicates some improvement in wound healing but still has many problems, with an overall rating of 5 / 10. A repair level of 1 indicates good wound healing, with an overall rating of 3 / 10. A repair level of 0 indicates complete healing, with an overall rating of 0 / 10.

[0147] Baseline comprehensive evaluation results: In the early stage of wound repair, the repair status was poor, with a comprehensive evaluation score of 6 / 10. The comprehensive evaluation took into account factors such as the patient's age, lifestyle habits, and treatment response.

[0148] The first time point comprehensive evaluation result: the wound is healing and progressing, with a comprehensive evaluation score of 5 / 10. The second time point comprehensive evaluation result: the wound is healing well, with a comprehensive evaluation score of 3 / 10. The third time point comprehensive evaluation result: the wound is completely healed, with a comprehensive evaluation score of 0 / 10.

[0149] Based on the repair level determination threshold, the following repair level conclusions are drawn:

[0150] The baseline repair level is 3, the repair level at time point 1 is 2, the repair level at time point 2 is 1, and the repair level at time point 3 is 0.

[0151] 7. Output standardized evaluation results

[0152] Finally, the standardized evaluation report generated based on the above data includes the following:

[0153] Assessment subject information: Patient B, male, 35 years old, target wound location and type information: perianal hemorrhoids, stage III.

[0154] Administration information: Recombinant collagen hemorrhoid wound repair gel, administered via intracavitary injection and topical application.

[0155] Wound imaging data: Wound imaging records at each time point.

[0156] The report provides a comparative analysis of wound imaging data and repair grades. A unified statistical methodology was used throughout the assessment process to ensure data consistency and comparability across institutions, and all data were quantified using standardized scales.

[0157] Quantitative results: wound extent, wound exudation, bleeding manifestations, and symptom scores.

[0158] Overall evaluation results: a comprehensive evaluation of baseline and follow-up time points.

[0159] Repair level conclusion: Repair level at each point in time.

[0160] The report can be used for cross-individual and cross-institutional review and comparison of assessment results, providing a basis for subsequent treatment plans.

[0161] Through the above steps, no serious complications occurred during the treatment. The treatment plan was simple and highly operable, demonstrating that the repair gel has promising clinical application prospects. Standardized wound quantification and symptom scoring methods provide a reliable basis for evaluating treatment effectiveness across individuals and institutions.

[0162] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A method for evaluating the repair of hemorrhoidal wounds using recombinant collagen, characterized in that, include: S1. The assessment object is determined to be a hemorrhoid wound or a post-hemorrhoid surgery wound. The evaluated intervention is determined to be the use of recombinant collagen hemorrhoid wound repair gel at the target site. The use includes intracavitary injection and topical application. Before the assessment begins, assessment rules are uniformly set and solidified for consistent execution across individuals and institutions. The assessment rules include: a unified observation time point system, a unified assessment dimension system, quantitative grading standards corresponding to each assessment dimension, a comprehensive judgment standard, and a repair level judgment threshold corresponding to the comprehensive judgment standard. Data collection specifications are uniformly set and solidified. The data collection specifications include wound imaging collection specifications and symptom scale collection specifications. The unified assessment dimension system includes objective wound dimensions and subjective symptom dimensions. The observation time point system includes a baseline time point and subsequent time points. The baseline observation time point is the observation time point before the first administration of recombinant collagen gel to the target wound. The subsequent observation time points are at least one observation time point determined according to a pre-set follow-up observation arrangement after the first administration of recombinant collagen gel to the target wound. S2. At the baseline observation time point, the target wound is collected in a standardized manner according to the data collection specifications. The standardized collection includes collecting wound images containing scale reference information and performing consistency verification, as well as collecting scale data corresponding to the subjective dimension of the symptoms to form a baseline dataset. S3. At each subsequent observation time point, the standardized data collection was repeated on the same target wound according to the data collection specifications, and consistency verification was performed to form a follow-up dataset. S4. Based on the quantitative grading criteria and comprehensive judgment criteria, the baseline dataset and each follow-up dataset are quantitatively processed to obtain quantitative results. The quantitative results include objective dimension quantitative results and subjective symptom grading results. Based on the quantitative results, a comprehensive evaluation result corresponding to each observation time point is generated. The comprehensive evaluation result includes the baseline comprehensive evaluation result and the comprehensive evaluation result of each subsequent observation time point. S5. Compare the comprehensive evaluation results of each subsequent observation time point with the baseline comprehensive evaluation results, and output the repair level conclusion of the target wound according to the repair level determination threshold, generating a standardized evaluation result that includes the observation time point system, quantitative results, comprehensive evaluation results and repair level conclusion.

2. The recombinant collagen hemorrhoid wound repair assessment method according to claim 1, characterized in that: The follow-up observation arrangement includes a first follow-up observation time point after the first administration of the recombinant collagen gel to the target wound, and at least one follow-up observation time determined after the completion of the last administration of a pre-set administration course, which is a series of administration phases for the same target wound that are pre-set and solidified before the start of the evaluation.

3. The recombinant collagen hemorrhoid wound repair assessment method according to claim 1, characterized in that: The wound imaging acquisition specifications stipulate acquisition methods for different wound locations: for intracavitary wounds, an anoscope camera is used to acquire wound images, and for external perianal wounds, an external imaging device is used to acquire wound images. The scale reference information is a scale mark of the same specification or the calibration scale information of the imaging device.

4. The recombinant collagen hemorrhoid wound repair assessment method according to claim 1, characterized in that: The consistency check includes checking the consistency of the acquisition conditions of the acquired wound images. The consistency of acquisition conditions includes: consistent acquisition devices, consistent acquisition perspectives, and complete and identifiable scale reference information. When the consistency check fails, the wound images of the target wound are re-acquired and the consistency check is re-executed.

5. The recombinant collagen hemorrhoid wound repair assessment method according to claim 1, characterized in that: The quantitative grading criteria for the objective dimensions of the wound include: identifying the wound boundary based on scale reference information to obtain a quantitative result of the wound range, and grading and recording the wound exudation and bleeding manifestations. The comprehensive judgment criteria generate an objective dimension quantitative result based on the quantitative result of the wound range, the record of wound exudation, and the record of bleeding manifestations.

6. The recombinant collagen hemorrhoid wound repair assessment method according to claim 1, characterized in that: The scale data was obtained according to a unified scale collection standard, which included a grading and recording method for the three symptoms of pain, swelling, and post-defecation bleeding. The data was collected using the same scale items and grading criteria at both the baseline observation time point and each subsequent observation time point. The quantification result of the subjective dimension of symptoms was obtained by converting the scale data collected at the baseline observation time point and each subsequent observation time point according to the quantification grading criteria.

7. The recombinant collagen hemorrhoid wound repair assessment method according to claim 1, characterized in that: The comprehensive judgment criteria include conflict handling rules. The conflict handling rules stipulate that when the objective dimension quantification results and the subjective dimension grading results of symptoms point to inconsistent repair trends, the comprehensive evaluation results shall be determined based on the objective dimension quantification results of the wound, and the inconsistent situations shall be marked in the standardized evaluation results.

8. The recombinant collagen hemorrhoid wound repair assessment method according to claim 1, characterized in that: The standardized assessment results are output using a preset report template, which includes information on the assessment object, the target wound location and type, the method of administration, wound images at each observation time point, quantitative results, comprehensive evaluation results, and a conclusion on the repair level.

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