Endoluminal Vacuum Therapy Using a New "Fistula Sponge" in Treating Defects of the Upper Gastrointestinal Tract-A Comparative, Retrospective Cohort Study.

Background and Objectives: Anastomotic insufficiencies (AI) and perforations of the upper gastrointestinal tract (uGIT) result in high morbidity and mortality. Endoscopic stent placement and endoluminal vacuum therapy (EVT) have been established as surgical revision treatment options. The Eso-Sponge® is the only licensed EVT system with limitations in treating small defects (<10 mm). Therefore, a fistula sponge (FS) was developed for the treatment of such defects as a new therapeutic approach. The aim of this study was to evaluate both EVT options' indications, success rates, and complications in a retrospective, comparative approach. Materials and Methods: Between 01/2018 and 01/2021, the clinical data of patients undergoing FS-EVT or conventional EVT (cEVT; Eso-Sponge®, Braun Melsungen, Melsungen, Germany) due to AI/perforation of the uGIT were recorded. Indication, diameter of leakage, therapeutic success, and complications during the procedure were assessed. FSs were prepared using a nasogastric tube and a porous drainage film (Suprasorb® CNP, Lohmann & Rauscher, Rengsdorf, Germany) sutured to the distal tip. Results: A total of 72 patients were included (20 FS-EVT; 52 cEVT). FS-EVT was performed in 60% suffering from AI (cEVT = 68%) and 40% from perforation (cEVT = 32%; p > 0.05). FS-EVT's duration was significantly shorter than cEVT (7.6 ± 12.0 d vs. 15.1 ± 14.3 d; p = 0.014). The mean diameter of the defect was 9 mm in the FS-EVT group compared to 24 mm in cEVT (p < 0.001). Therapeutic success was achieved in 90% (FS-EVT) and 91% (cEVT; p > 0.05). Conclusions: EVT comprises an efficient treatment option for transmural defects of the uGIT. In daily clinical practice, fistulas < 10 mm with large abscess formations poses a special challenge since intraluminal cEVT usually is ineffective. In these cases, the concept of extraluminal FS placement is safe and effective.

Applications of endoscopic vacuum therapy in the lower gastrointestinal tract: Tips and tricks and a review of the literature.

Endoscopic vacuum therapy (EVT) is an established technique for the treatment of rectal wall defects and especially anastomotic leaks. A wide range of EVT devices, both handmade and commercially available, allow for their successful placement even in small defects and difficult localizations. Reported success rates range between 85 and 97 %, while periintervenional morbidity is low and major adverse events are very rare. EVT has proven its effectiveness in the lower gastrointestinal tract and is now considered first line treatment for pelvic anastomotic leaks. This narrative review summarizes the current literature on EVT in the lower gastrointestinal tract, focusing on its indications, technical aspects and results, and offers tips and tricks for its clinical applications.

In vitro evaluation of a hybrid negative pressure system for wound therapy.

OBJECTIVE: The objective of this study was to assess whether negative pressure could be maintained accurately and repeatably with a wall-suction-based hybrid negative pressure wound therapy (h-NPWT) system by comparing it with a commercial negative pressure wound therapy (NPWT) device. STUDY DESIGN: In vitro experimental study. METHODS: A commercial NPWT device (control) and three h-NPWT devices, with 0, 3, and 6 meters of additional tubing using the hospital-wall suction (groups 1, 2, and 3 respectively), were applied sequentially to a commercial NPWT dressing on a silicone skin substrate and set to run at a continuous pressure of -125 mmHg. The pressure within the wound space was monitored at 10 second intervals for 24 h. The process was repeated five times for each group. RESULTS: The commercial NPWT device produced an average pressure variance of 3.02 mmHg, and the h-NPWT produced average variances of 4.38, 4.24 and 4.20 mmHg for groups 1, 2 and 3, respectively. All groups produced an average pressure within 0.15 mmHg of -125 mmHg over the 24-hour period, and the h-NPWT systems produced the smallest range with all values remaining within a ±5% variation from -125 mmHg. CONCLUSION: The h-NPWT system achieved negative pressures that were comparable to those of a commercial control NPWT device. The addition of tubing between the skin substrate and the canister did not affect the pressure applied at the wound site. CLINICAL SIGNIFICANCE: The h-NPWT device tested in this study can be considered as an alternative for negative wound therapy when a commercial device cannot be used.

Economic Analysis of AbClo, a Novel Abdominal Fascia Closure Device, for Patients With an Open Abdomen Following Trauma or Acute Abdominal Surgery.

BACKGROUND: Open Abdomen (OA) cases represent a significant surgical and resource challenge. AbClo is a novel non-invasive abdominal fascial closure device that engages lateral components of the abdominal wall muscles to support gradual approximation of the fascia and reduce the fascial gap. The study objective was to assess the economic implications of AbClo compared to negative pressure wound therapy (NPWT) alone on OA management. METHODS: We conducted a cost-minimization analysis using a decision tree comparing the use of the AbClo device to NPWT alone among patients with midline laparotomy for trauma or acute abdominal surgery who were ineligible for primary fascial closure. The time horizon was limited to the length of the inpatient hospital stay, and costs were considered from the perspective of the US Medicare payer. Clinical effectiveness data for AbClo was obtained from a randomized clinical trial. Cost data was obtained from the published literature. Probabilistic and deterministic sensitivity analyses were performed. The primary outcome was incremental cost. RESULTS: The mean cumulative costs per patient were $76 582 for those treated with NPWT alone and $70,582 for those in the group treated with the AbClo device. Compared to NPWT alone, AbClo was associated with lower incremental costs of -$6012 (95% CI -$19 449 to +$1996). The probability that AbClo was cost-savings compared to NPWT alone was 94%. CONCLUSIONS: The use of AbClo is an economically attractive strategy for management of OA in in patients with midline laparotomy for trauma or acute abdominal surgery who were ineligible for primary fascial closure.

The role of personal-use negative pressure wound therapy with enhanced functionality in achieving wound-related treatment goals: a small prospective study.

BACKGROUND: NPWT is widely used to manage hard-to-heal wounds, and many different devices are available. Personal-use NPWT systems are becoming more popular, although current options have limited functionality. PURPOSE: The primary objective was to determine acceptable progress of wounds towards a predefined goal of therapy for a variety of open wounds being treated with a novel NPWT personal-use system with enhanced functionality. METHODS: In this prospective, nonrandomized, interventional study, patients were treated with a personal-use NPWT system over 4 weeks, initially in a wound care clinic setting, and were discharged home with the device. Clinician satisfaction with the device was also evaluated. RESULTS: Ten patients were evaluated. Acceptable progress towards all predetermined goals was reached for all patients; a median reduction in wound volume of 84.6% and improved granulation was achieved within the 4-week treatment period. No device-related deficiencies were reported. In general, clinicians were satisfied with the device's ease of use and mobility. CONCLUSION: Personal-use NPWT is easy to use, has positive effects on healing on a variety of wound types, and is well accepted by clinicians.

Endoscopic Vacuum Therapy for Left-Sided Colorectal Anastomotic Leak Without Fecal Diversion.

BACKGROUND: Endoscopic vacuum therapy for the treatment of rectal anastomotic leak has been shown to be effective and safe. The majority of patients are treated after fecal diversion to avoid further septic complications. OBJECTIVE: To report the effectiveness of endoscopic vacuum therapy for rectal anastomotic leak without diversion compared to secondary stoma creation. DESIGN: Retrospective cohort analysis. SETTINGS: University hospital, single-center. PATIENTS: Patients undergoing sigmoid or rectal resection without fecal diversion during primary surgery who were treated with endoscopic vacuum therapy for clinically relevant anastomotic leak. MAIN OUTCOME MEASURES: Treatment success (sepsis control, granulation and closure of the leak cavity, and no subsequent interventional or surgical procedure required); treatment duration; complications associated with endoscopic vacuum therapy; outpatient treatment; and restoration of intestinal continuity in diverted patients. RESULTS: Fifty-seven patients were included. In 20 patients (35%), endoscopic vacuum therapy was initiated without secondary diversion since the leak was extraperitoneal, and the sponge could be placed into the leak cavity with an adequate seal toward the lumen. In 18 patients (90%), this approach was successful. None of these patients required subsequent diversion in the further course of their disease. In two patients, secondary diversion was necessary due to treatment failure. Balloon dilatation for luminal stenosis was required in two patients. When comparing patient and treatment characteristics of patients with and without a stoma, including treatment success and duration, no significant differences were found. Restoration of intestinal continuity was achieved in 69% of diverted patients. LIMITATIONS: Unrandomized, retrospective study design; confounding factors of treatment assignment; low patient numbers and short follow-up of diverted patients; and low statistical power. CONCLUSION: In this single-institution study, endoscopic vacuum therapy for rectal anastomotic leak was successful in 90% of patients without diversion with regard to sepsis control, granulation of the leak cavity, avoidance of surgery, and long-term stoma-free survival. See Video Abstract at http://links.lww.com/DCR/B737.TERAPIA ENDOSCÓPICA POR ASPIRACIÓN AL VACÍO EN CASOS DE FUGA ANASTOMÓTICA RECTO-CÓLICA IZQUIERDA SIN OSTOMÍA DE PROTECCIÓNANTECEDENTES:Se ha demostrado que la terapia endoscópica por aspiración al vacío en casos de fuga anastomótica recto-cólica izquierda en el tratamiento de la fuga anastomótica rectal es eficaz y segura. La mayoría de los casos beneficiaron del tratamiento después de la confeción de un ostomía de protección para evitar más complicaciones sépticas.OBJETIVO:Demostrar la efectividad de la terapia endoscópica por aspiración al vacío en casos de fuga anastomótica recto-cólica izquierda sin ostomía de protección comparada con los casos que tuvieron la creación de una ostomía secundaria.DISEÑO:Análisis de cohortes de tipo retrospectivo.AJUSTE:Hospital universitario, unicéntrico.PACIENTES:Aquellos pacientes sometidos a una resección sigmoidea o rectal sin ostomía de protección durante una cirugía primaria, y que fueron tratados con terapia endoscópica por aspiración al vacío en caso de fuga anastomótica clínicamente relevante.PRINCIPALES MEDIDAS DE RESULTADO:Tratamiento exitoso (control de la sepsis, granulación y cierre de la cavidad de la fuga, sin requerir procedimiento quirúrgico o intervención ulteterior); duración del tratamiento; complicaciones asociadas con la terapia endoscópica por aspiración al vacío; tratamiento ambulatorio; restablecimiento de la continuidad intestinal en los pacientes portadores de ostomía.RESULTADOS:Se incluyeron 57 pacientes. En 20 pacientes (35%), se inició la terapia endoscópica por aspiración al vacío sin derivación secundaria, ya que la fuga era extraperitoneal y la esponja podía colocarse en la cavidad de la fuga con un sellado adecuado hacia el lumen. En 18 pacientes (90%), este enfoque fue exitoso. Ninguno de estos pacientes requirió una derivación posterior durante la evolución de la enfermedad. En dos pacientes, fue necesaria una derivación secundaria debido al fracaso del tratamiento. Se requirió dilatación con balón por estenosis luminal en dos pacientes. Al comparar las características de los pacientes y del tratamiento con y sin ostomía, incluido el éxito y la duración del tratamiento, no se encontraron diferencias significativas. El restablecimiento de la continuidad intestinal se logró en el 69% de los pacientes derivados.LIMITACIONES:Diseño de estudio retrospectivo no aleatorio; factores de confusión en la asignación del tratamiento; escaso número de pacientes y seguimiento a corto plazo de los pacientes ostomizados; bajo poder estadístico.CONCLUSIÓN:En este estudio de una sola institución, la terapia al vacío por vía endoscópica en casos de fuga anastomótica rectal fue exitosa en el 90% de los pacientes sin derivación con respecto al control de la sepsis, granulación de la cavidad de la fuga, como se evitó la cirugía y la sobrevida sin ostomía a largo plazo. Consulte Video Resumen en http://links.lww.com/DCR/B737. (Traducción-Dr. Xavier Delgadillo).

The Effectiveness of Vacuum-Assisted Closure Device in Managing Intramuscular Tuberculosis.

ABSTRACT: Tuberculosis (TB) is endemic to some geographic areas such as Africa, Eastern Europe, Asia, Latin America, and the Caribbean. It is called the great mimicker because of its diverse and variable presentation and affects almost every organ in the body with different symptomatology. Often, TB causes empyema necessitans, the rarest forms of which are intramuscular and cutaneous. Here, the authors report a case of empyema necessitans and intramuscular TB, which was managed successfully with negative-pressure wound therapy. The treatment provided a good outcome and patient satisfaction compared with traditional invasive surgical options.

Single-Use Negative Pressure Wound Therapy Devices: A Technologic Analysis.

PURPOSE: The purpose of this technologic analysis was to evaluate single-use negative pressure wound therapy (sNPWT) devices. APPROACH: Published literature regarding negative pressure wound therapy, particularly focusing on single-use or disposal devices, was reviewed. Varied features of devices currently available in the United States were drawn from use instructions published by individual manufacturers. Safety information regarding sNPWT was derived from the Manufacturer and User Facility Device Experience (MAUDE) Database. CONCLUSIONS: Single-use or disposable negative pressure wound therapy devices provide a safe and effective alternative to traditional negative pressure wound therapy. These devices promote healing of select open wounds and reduce complication rates in closed surgical incisions, when used in accordance with manufacturer guidelines. They may be used in any setting, but they are designed for use in home care and may be applied as a primary treatment option or following a course of traditional negative pressure wound therapy.

Negative Pressure Wound Therapy Devices With Instillation/Irrigation: A Technologic Analysis.

PURPOSE: The purpose of this technologic analysis was to critique technologic features of devices designed to deliver negative pressure wound therapy with instillation or irrigation (iNPWT). APPROACH: Published literature regarding negative pressure wound therapy (NPWT) devices with the added feature of instillation or irrigation was reviewed to provide an overview of iNPWT. Varied features of devices currently available in the United States were described based on instructions published by individual manufacturers. Safety information regarding iNPWT was derived from the Manufacturer and User Facility Device Experience (MAUDE) Database. CONCLUSIONS: The additional option of instillation or irrigation available with some NPWT devices may provide clinical benefits in carefully selected patients. Advantages may be related to facilitated removal of thick exudate and necrotic tissue. Devices with instillation options are indicated for inpatient settings, with ongoing monitoring of health care professionals. A simpler device with an intermittent irrigation option may be used in the home setting, with proper supervision. More research is needed to demonstrate the clinical effectiveness and cost of the therapy.

Negative-pressure wound therapy in skin grafts: A systematic review and meta-analysis of randomized controlled trials.

INTRODUCTION: Although skin grafts are widely used in reconstruction of large skin defect and complex wounds, many factors lead to suboptimal graft take. Negative-pressure wound therapy (NPWT) reportedly increases the graft take rates when added to skin grafting, but a summary analysis of the data of randomized controlled trials has yet to be performed. We conducted this systematic review and meta-analysis of randomized controlled trials to compare the effectiveness and safety of NPWT and non-NPWT for patients with skin grafts. METHODS: We searched PubMed, Embase, Cochrane Library, and CNKI for relevant trials based on predetermined eligibility criteria from database establishment to February 2020. Two reviewers screened citations and extracted data independently. The quality of the included studies was evaluated according to the Cochrane Handbook, whereas statistical heterogeneity was assessed using chi-square tests and I2 statistics. Review Manager 5.3 was used for statistical analysis. RESULTS: Ten randomized controlled trials with 488 patients who underwent NPWT or non-NPWT were included. Compared with non-NPWT, NPWT yielded an improved the percentage of graft take, a reduction in days from grafting to discharge, with lower relative risk of re-operation, and no increased relative risk of adverse event. Further, the subgroup analysis showed an improved the percentage of graft take in negative pressure of 80 mmHg, and no improved the percentage of graft take in negative pressure of 125 mmHg. CONCLUSION: NPWT is more effective than non-NPWT for the integration of skin grafts, and the negative pressure of 80 mmHg can be recommended. Data on adverse events and negative pressure are, however, limited. A better understanding of complications after NPWT and the ideal negative pressure for the integration of skin grafts is imperative.

Negative pressure wound therapy: device design, indications, and the evidence supporting its use.

Introduction: Negative pressure wound therapy (NPWT) has become a mainstay in the armamentarium for wound care. Since the initial commercial vacuum-assisted closure device became available in 1995, subsequent research has confirmed the positive physiological effects of negative pressure on wound healing. Traditionally, NPWT has been used to improve healing of open nonsurgical wounds by secondary intention. However, the clinical applications of NPWT have significantly broadened, and now also include use in open surgical wounds, closed surgical incisions, and skin graft surgery. In addition, devices have evolved and now include functionality and features such as instillation, antimicrobial sponges, and portability.Areas covered: This article reviews the history, background, and physiology underlying NPWT, as well as the most commonly used devices. In addition, an evidence-based discussion of the current clinical applications of NPWT is presented, with a focus on those with high levels of evidence.Expert opinion: Future directions for device development include modifications to increase ease of use by patients and to allow its use in a broader array of anatomic areas. Lastly, more research with high levels of evidence is needed to better define the outcomes associated with NPWT, including in relation to specific clinical applications and cost.

Closing Contaminated Fascial Defects With Synthetic Mesh and a Vacuum-Assisted Closure Device.

BACKGROUND: The use of synthetic mesh is considered too high risk, and therefore, not an option when closing a contaminated abdominal fascial defect. This study evaluated the clinical outcomes when using synthetic mesh combined with vacuum-assisted closure (VAC) dressing to close these facial defects. MATERIALS AND METHODS: From 2010 to 2016, a retrospective review was performed, including 34 patients in a single rural trauma center who underwent a damage control laparotomy in the presence of a contaminated or infected field. Definitive abdominal closure with a bridging polypropylene mesh along with the application of a VAC dressing was done in all cases. Data collection included baseline demographics, operative indication, postoperative complications, mortality and length of follow up. RESULTS: Median age of the patients was 67 y (IQR 40-87 y), with 22 (65%) being male at the time of operation. The median duration of clinical follow-up was 15.15 mo. The observed complications included three fistulas, two hernias, nine draining sinus tracts, and three mesh explanations with an overall complication rate of 41.1%. Although the absolute observed fistula rate was 8.8% (3 cases), the adjusted mesh-related fistulas formation rate after chart review was 0.0%. No mortalities were attributed directly to mesh-related complication. CONCLUSIONS: This study found no mesh-related fistulas when using a synthetic mesh along with a VAC dressing for abdominal closure in a contaminated field. These results may provide a platform for further study regarding the safety of this technique.

Negative pressure wound therapy for prevention of surgical site infection in patients at high risk after clean-contaminated major pancreatic resections: A single-center, phase 3, randomized clinical trial.

BACKGROUND: Surgical site infections are an important burden of pancreatic surgery, prolonging hospitalization and delaying adjuvant treatment. The aim of this study was to compare negative pressure wound therapy with standard sterile dressing in terms of the prevention of non-organ-space surgical site infection (superficial and deep surgical site infection) in the high-risk setting. METHODS: The trial was conducted at the University of Verona Hospital Trust, Verona, Italy, from July 25, 2018, through October 10, 2019, among adults undergoing surgery for periampullary neoplasms. Only patients at high-risk for surgical site infection based on body mass index, diabetes, steroids, neoadjuvant therapy, American Society of Anesthesiologists score, Charlson comorbidity index, duration of surgery, and blood loss were included and randomized. RESULTS: A total of 351 patients were screened, 100 met the inclusion criteria and were 1:1 allocated in the 2 arms. The difference in terms of non-organ-space surgical site infection comparing negative pressure wound therapy with standard sterile dressing was not significant (10.9 vs 12.2%, risk ratio [RR] 1.144, confidence interval [CI] 95% 0.324-4.040, P = 1.000). Hematomas (4.3 vs 2%, RR 1.565, CI 95% 0.312-7.848, P = .609) and organ-space infections (46.7 vs 43.8%, RR 1.059, CI 95% 0.711-1.576, P = .836) were similar. Negative pressure wound therapy prevented the development of seromas (0 vs 12.2%, RR 0.483, CI 95% 0.390-0.599, P = .027). The aesthetic result assessed on postoperative day 7 was better in the negative pressure wound therapy group (visual analogue scale, 8 vs 7, P = .029; Stony Brook Scar Evaluation Scale, 3.2 vs 2.5, P = .009), but it was no more evident on postoperative day 30 after a total number of 23 dropouts. CONCLUSION: Compared with standard sterile dressing, negative pressure wound therapy is not associated with an improved rate of non-organ-space surgical site infection after surgery for periampullary neoplasms in patients at high risk for surgical site infection. Additional studies will help identify the population that could benefit most from this intervention.

Retrospective Clinical Evaluation of Negative-Pressure Wound Therapy for Infection Prevention Following Malignant Pelvic Bone Tumor Resection Reconstruction.

OBJECTIVE: To evaluate the clinical outcomes of negative-pressure wound therapy (NPWT) for infection prevention following pelvic reconstruction after malignant bone tumor resection. METHODS: The study involved 82 patients who underwent pelvic reconstruction following en-bloc resection of malignant bone tumors between January 2003 and January 2016. Forty patients were treated with NPWT via implantation of vacuum-sealing drainage (VSD) materials into the pelvic cavity to prevent infection and wound problems (VSD group), and the remaining 42 patients underwent conventional treatment (control group). Study authors compared the inpatient length of stay, antibiotic use, drainage volume, time to wound closure, and infection rates between groups. Investigators also conducted cell cultures of the wound cavity washing fluid and hematoxylin-eosin staining for VSD materials to find recurrent tumor cells. RESULTS: In the VSD group, one patient (2.5%) had a superficial wound problem. In the control group, 18 patients (42.9%) had deep infection or wound problems. The VSD group had a significantly decreased infection rate, duration of antibiotic administration and inpatient stay, as well as increased wound healing compared with the control group (P < .05). Further, no tumor cells were observed in the VSD material or the wound cavity washing fluid. CONCLUSIONS: The application of NPWT with VSD material may be an effective and reliable method for preventing infection in patients who undergo pelvic reconstruction following malignant tumor resection.

A novel treatment for CI extrusion with vacuum-assisted closure device.

OBJECTIVE: To assess if a vacuum-assisted closure device initially utilised as a temporising measure to dress a wound defect over a cochlear implant prior to definitive surgical intervention could instead be used to close the soft tissue and avoid surgery. METHOD: This is a case report describing the novel use of VAC (Vacuum-Assisted Closure Device) in the successful closure of a wound defect with cochlear implant hardware exposure post soft tissue infection during the Covid-19 pandemic. RESULTS: While the VAC system was initiated for temporary wound coverage, it was observed at each dressing change to be successfully decreasing the soft tissue defect for our patient. This resulted in complete epithelisation of the soft tissue defect at Day 35 and avoidance of a surgical procedure. The patient was able to restart wearing her device on Day 50 and Cochlear MAPping performed on Day 58 showed minimal changes in patient's current requirements compared to her settings pre-infection. CONCLUSION: The use of V.A.C dressing for a small soft tissue defect over an extruded cochlear implant seems promising as exemplified by our case study. However, due to the lack of literature, more studies should be done to prove its usefulness in such an application.

Study Comparing Platform Wound Dressing, a Negative-Pressure Device without a Filler, with Three Conventional Negative-Pressure Wound Therapy Systems in the Treatment of Excisional and Incisional Wounds.

BACKGROUND: All common negative-pressure wound therapy systems include a material, usually foam or gauze, at the wound/device interface. In this preclinical study, the authors have compared the effects on different wound healing parameters in the three most common negative-pressure wound therapy systems (i.e., V.A.C.VIA, PREVENA, and PICO) with a new device without foam or gauze (i.e., Platform Wound Dressing). A strong effort was made to avoid bias. The study was conducted under good laboratory practice conditions, with the presence of an independent observer. METHODS: In pigs, three types of wounds were studied: full-thickness excisions, open incisions, and sutured closed incisions. Several macroscopic and microscopic parameters were studied. The pigs were euthanized on day 9 and all wounds were processed for histology and excisions for immunohistochemistry. RESULTS: In general, the devices produced similar results, with only a few significant differences. In the excisions, the Platform Wound Dressing reduced wound area more than the V.A.C.VIA and the PICO. In the excisional wounds, reepithelialization was the same. In open incisions, PREVENA was better than the Platform Wound Dressing. Histologic examination showed that, in open incisions, there was less inflammation in the PREVENA-treated in comparison with the Platform Wound Dressing- and the PICO-treated wounds. Immunohistochemical analyses showed that the Platform Wound Dressing-treated excisions had significantly more blood vessels (von Willebrand factor) than the V.A.C.VIA-treated ones and that the PICO caused less T-cell activation (CD3) than the other two. CONCLUSION: The devices-with foam, with gauze, or without either and just an embossed membrane-performed equally in general.