Method for treating external pancreatic fistulas using two-phase VAC protocol

Abstract

FIELD: abdominal surgery.SUBSTANCE: used to treat external pancreatic fistulas of class B and C. A sealing dressing is applied to the fistula area with the installation of a drainage tube connected to a VAC system. At the first stage, a constant negative pressure of 120 mmHg is applied continuously until exudation from the wound stops, but for no more than 48 hours. The second stage involves a dynamic regimen lasting 6 days with continuous cyclical changes in negative pressure, wherein the pressure increases from 80 to 100 mmHg and then decreases back to 80 mmHg in each 6-minute cycle.EFFECT: this method prevents inflammation of the wound edges in the fistula area, optimizes drainage function at the initial stage of treatment, and accelerates granulation formation in the fistula area through a two-phase alternation of continuous and cyclical pressure.1 cl, 4 dwg, 1 ex

Description

[0001] The proposed method relates to the field of medicine, namely surgery, and can be used to treat class B and C pancreatic fistulas.

[0002] Pancreatic fistulas remain one of the most common, and in some cases severe, complications after pancreatic surgery. According to modern studies, after pancreaticoduodenectomy, the incidence of clinically significant fistulas (class B and C according to the ISGPS classification) is 18% for class B and 13% for class C, depending on the technique of anastomosis with the pancreas [1]. After distal resections, the incidence of fistulas of all classes reaches approximately 22.6%, classes B and C 15.8% [2]. Fistulas also develop after enucleation of pancreatic tumors with a frequency of up to 31.7% [3]. This raises the question of the need to develop new effective methods of local treatment, such as an optimized VAC therapy protocol.

[0003] VAC therapy, a technique used to treat post-surgical wounds, is currently widely known. Negative pressure wound therapy involves the use of continuous or intermittent negative pressure over a wide range of values ​​(usually from 125 to 75 mmHg) without strict regulation of the transition between modes. Parameter selection is often empirical, which does not allow for the most effective control of massive exudation and, consequently, skin maceration in the fistula area, or optimal stimulation of granulation tissue formation in the cavities associated with the fistula [4].

[0004] A METHOD OF IRRIGATION-ASPIRATION SANITATION OF PURULENT DISEASES OF SOFT TISSUES is known from the prior art [RU2806488C2, published: 01.11.2023], [5] characterized by preliminary surgical treatment of the purulent focus, installation of tubular perforated drains in sloping areas of the wound bed, irrigation of the wound cavity with an antiseptic solution and aspiration of the said solution after its exposure in the wound cavity, characterized in that a 0.1% solution of polyhexanide is used as an antiseptic solution for irrigation, and after aspiration of the said solution from the wound cavity, the volume of the wound cavity is reduced to the volume of the drains by vacuuming it at a vacuum level of 60 to 80 mm Hg. st., and the stages of irrigation and aspiration of the said solution after its exposure in the wound cavity are carried out sequentially in a cyclic mode until the wound cavity is cleared of inflammatory products and microbial bodies.

[0005] However, this method has a number of significant disadvantages compared to the proposed two-phase VAC protocol, namely: the use of low negative pressure (60-80 mmHg) is insufficient for effective control of massive exudation in fistulas; cyclic irrigation can lead to tissue maceration and disruption of the forming granulation tissue; there is no targeted stimulation of reparative processes, whereas our method provides a standardized effect with optimized pressure parameters (120 mmHg in the drainage phase and a continuously changing wave-like negative pressure from 80 to 100 mmHg in the granulation phase), which allows us to consistently solve the problems of active drainage and stimulation of healing, taking into account the specifics of pancreatic exudate.

[0006] Technical result: prevention of inflammation of the wound edges in the fistula area, optimization of the drainage function at the initial stage of treatment, acceleration of the formation of granulation in the fistula area, standardization of the VAC therapy protocol for this type of complications in order to ensure the reproducibility of the method and the predictability of the results of its application.

[0007] The proposed invention is aimed at eliminating the identified shortcomings of the known method, in particular: unregulated pressure, insufficient effectiveness of exudation control, lack of a differentiated approach to the phases of the wound process, the risk of tissue maceration and the lack of targeted stimulation of reparative processes, and is a method for treating pancreatic fistulas of classes B and C using a two-phase VAC therapy protocol.

[0008] Drawing Description:

[0009] Fig. 1

[0010] 1 - Sponge material

[0011] 2 - Silicone tube for drug administration

[0012] 3 - Semi-permeable patch

[0013] 4 - Negative pressure wound therapy device

[0014] 5 - Silicone tubes

[0015] 6 - Adapter

[0016] 7 - Ruler

[0017] Fig.2

[0018] 1 - Sponge material

[0019] 2 - Silicone tube for exudate removal

[0020] 3 - Semi-permeable patch

[0021] Fig.3

[0022] 8 - Wound after cessation of exudation

[0023] Fig.4

[0024] 9 - Final appearance before discharge

[0025] Implementation of the invention

[0026] Before starting therapy, the wound is prepared: the wound is cleaned, and the cavity is filled with a foam sponge of the appropriate size and shape, ensuring full contact with the wound surface. A sealing dressing is applied to the sponge, and a drainage tube is inserted, which is connected to the VAC system.

[0027] In the first stage, to quickly control massive exudation, a constant negative pressure of 120 mmHg is applied continuously (without interruption). The duration of the first stage is determined by the dynamics of the discharge and is completed after the exudation has completely ceased, but no later than 48 hours after the start of therapy. After this, the patient moves on to the second stage, during which a dynamic mode with continuous, cyclic changes in negative pressure is used for 6 days: in each 6-minute cycle, the pressure gradually increases from 80 to 100 mmHg and decreases back to 80 mmHg, after which the cycle is repeated without interruption. The total duration of the second stage is 6 days of continuous exposure in this dynamic mode.

[0028] This combination of strictly defined parameters enables a consistent solution to the problems of active drainage and stimulation of granulation tissue. Maintaining a negative pressure of 120 mmHg for the initial phase ensures effective drainage of aggressive exudate, while the use of a dynamic mode in the form of continuously changing negative pressure waves from 80 to 100 mmHg and a shortened 6-minute cycle optimizes microcirculation and accelerates healing. The technical result consists of preventing inflammation of the wound edges in the fistula area, optimizing drainage function at the initial stage of treatment, accelerating granulation formation in the fistula area, standardizing the approach, and reducing fistula healing time through a well-founded intervention at all stages of the wound healing process.

[0029] Clinical example

[0030] A clinical trial of the proposed method was conducted on a patient with postoperative wound exudation following pancreaticoduodenectomy. The use of a two-phase VAC therapy protocol with the parameters specified in the invention confirmed its effectiveness, allowing for the relief of exudation and stimulation of wound healing within 12 days.

[0031] The obtained results indicate the potential for introducing the developed protocol into clinical practice to improve the outcomes of fistula treatment after pancreatic surgery.

[0032] Bibliography:

[0033] 1) Nahm CB, Connor SJ, Samra JS, Mittal A. Postoperative pancreatic fistula: a review of traditional and emerging concepts. Clin Exp Gastroenterol. 2018 Mar 15;11:105-118. doi: 10.2147 / CEG.S120217. PMID: 29588609; PMCID: PMC5858541.Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016 / j.surg.2005.05.001. PMID: 16003309;

[0034] 2) Lee SJ, Choi IS, Moon JI. Conversion to pancreaticogastrostomy for salvage of disrupted pancreaticojejunostomy following pancreaticoduodenectomy. Ann Surg Treat Res. 2022 Oct;103(4):217-226. doi: 10.4174 / astr.2022.103.4.217. Epub 2022 Oct 7. PMID: 36304194; PMCID: PMC9582620;

[0035] 3) Beger HG. Prämaligne, zystische Neoplasien und neuroendokrine Tumoren des Pankreaskopfes - Ist die Kausch-Whipple-Resektion eine adäquate Therapie? [Premalignant cystic neoplasms and neuroendocrine tumors of the pancreatic head-Is the Kausch-Whipple resection an adequate treatment?]. Chirurgie (Heidelb). 2024 Jun;95(6):461-465. German. doi: 10.1007 / s00104-024-02070-5. Epub 2024 Apr 3. PMID: 38568302; PMCID: PMC11096214;

[0036] 4) Liu GH, Xu ZY, Tan JH, Li JX, Xu JE, Tan XY, Zhai JW, Wu JY, Zhong GH, Li MY. Tapering-pressure VAC therapy for wound exudation in POPF after pancreatoduodenectomy: a single-center experience. Front Surg. 2025 Jul 10;12:1612420. doi: 10.3389 / fsurg.2025.1612420. PMID: 40709063; PMCID: PMC12287089.

[0037] 5) 2806488C2 Russian Federation. Patent for invention No. 2806488C2. Method of irrigation-aspiration sanitation of purulent diseases of soft tissues / Sergeev V. A., Glukhov A. A.; applicant and patent holder Sergeev V. A., Glukhov A. A. - No. 2022110051; declared 14.04.2022; published 01.11.2023, Bulletin No. 31. - 12 p.

Claims

A method for treating class B and C external pancreatic fistulas using a two-phase VAC protocol, including the application of a sealing dressing with the installation of a drainage tube that is connected to the VAC system, characterized in that at the first stage, a constant negative pressure of 120 mmHg is used in a continuous mode until exudation from the wound ceases, but for no more than 48 hours, then at the second stage, a dynamic mode with a continuous cyclic change in negative pressure is used: in each 6-minute cycle, the pressure increases from 80 to 100 mmHg and decreases back to 80 mmHg, the duration of the second stage is 6 days.

Images