Negative Pressure Therapy System Research Articles

Outcomes of Two Different Negative Pressure Therapy Systems for Closed Incision Management in Knee and Hip Arthroplasty: A Systematic Review and Meta-Analysis.

Closed incision negative pressure therapy (ciNPT) has been adopted into practices of diverse surgical specialties to help reduce postsurgical complication risks. There are two primary commercially available systems that deliver ciNPT through different mechanisms. The purpose of this meta-analysis is to compare the potential effects of two different ciNPT systems on clinical outcomes following hip and knee arthroplasty. A systematic literature search was conducted to identify hip and knee arthroplasty studies comparing the incidence of surgical site infections (SSIs) and surgical site complications (SSCs) versus standard of care (SOC) following the use of two different ciNPT systems. Four meta-analyses were performed by calculating risk ratios (RR) to assess the effect of (1) ciNPT with foam dressing (ciNPT-F) versus SOC and (2) ciNPT with multilayer absorbent dressing (ciNPT-MLA) versus SOC. Comprehensive Meta-Analysis Version 3.0 (Biostat Inc., Englewood, NJ) software was used to perform the analyses. Twelve studies comparing ciNPT-F to SOC and six studies comparing ciNPT-MLAto SOC were analyzed. SSI rates were reported in seven of 12 studies involving ciNPT-F. In those, ciNPT-F significantly reduced the incidence of SSI (RR = .401, 95% confidence interval (CI) = .190, .844; p = .016). Across four of six studies that reported SSI rates, there was no significant difference in SSI rates between ciNPT-MLAvs SOC (RR = .580, 95% CI = .222, 1.513; p = .265). SSC rates were evaluated in eight of 12 ciNPT-F studies that reported SSC rates. This meta-analysis of the eight ciNPT-F studies showed significantly reduced SSC rates with ciNPT-F vs SOC (RR = .332, 95% CI = .236, .467; p < 0.001). For ciNPT-MLA, five of six studies reported SSC rates. In those, there was no significant difference in SSC rates between ciNPT-MLA vs SOC (RR = .798, 95% CI = .458, 1.398; p = .425). These meta-analyses results showed a significant reduction in SSI and SSC rates in the ciNPT-F group vs SOC and no difference in SSI and SSC rates in the ciNPT-MLA group vs SOC. The reasons for these observed differences were not evaluated as part of this study.Future controlled clinical studies comparing outcomes between different ciNPT systems over closed orthopedic incisions would help to validate these study results.

Simple suture whipstitch closure is a reasonable option for many patients requiring temporary abdominal closure for blunt or penetrating trauma

ObjectivesMultiple temporary abdominal closure (TAC) techniques are currently used to manage the open abdomen (OA) in severely injured trauma patients, with variability in efficacy and cost. We evaluated the clinical...

Open abdominal management after ruptured abdominal aortic aneurysm repair: from a single-center study in Japan

PurposeWe investigated the utility of the open abdominal management (OA) technique for ruptured abdominal aortic aneurysm (rAAA).MethodsBetween January 2016 and August 2021, 33 patients underwent open surgery for rAAA at our institution. The patients were divided into OA (n = 12) and non-OA (n = 21) groups. We compared preoperative characteristics, operative data, and postoperative outcomes between the two groups. The intensive care unit management and abdominal wall closure statuses of the OA group were evaluated.ResultsThe OA group included significantly more cases of a preoperative shock than the non-OA group. The operation time was also significantly longer in the OA group than in the non-OA group. The need for intraoperative fluids, amount of bleeding, and need for blood transfusion were significantly higher in the OA group than in the non-OA group. Negative pressure therapy (NPT) systems are useful in OA. In five of the six survivors in the OA group, abdominal closure was able to be achieved using components separation (CS) technique.ConclusionsNPT and the CS technique may increase the abdominal wall closure rate in rAAA surgery using OA and are expected to improve outcomes.

MASTECTOMIA BILATERAL COM USO DE PICO™ SOFTPORT – SISTEMA DE TERAPIA DE PRESSÃO NEGATIVA DE FERIDAS

Currently, the main form of malignancy among women is breast cancer. With the advent of radiotherapy, conservative breast surgery (lumpectomy) has become a possible technique. However, radical mastectomy still maintains its indications in the face of a more advanced pathology or in patients with deleterious BRCA 1 / BRCA 2 mutations. Unfortunately, complications of the surgical wound exist. Faced with this problem, PICO ™ Softpor - Negative pressure wound therapy system, is a unique device that has been used in the negative pressure wound therapy system to improve wound healing, this includes improved perfusion, removal of excess fluid and edema leading to less tension in the surgical wound. The study aimed to report the experience of using the Wound Negative Pressure Therapy System through PICO ™ Softport in the surgical treatment of breast cancer through a case report. Patient M. R. V., female, 57 years old, G2P2A0, asymptomatic with a diagnosis of T4BN0M0 in the right breast and T1N0M0 in the left breast was submitted to bilateral modified radical mastectomy. We used bilateral dressings with the Wound Negative Pressure Therapy System in the form of PICO ™ Softport, which made it possible to reduce the incision healing complications. After surgical recovery, the patient underwent adjuvant radiotherapy, presenting himself until the moment of this stable report using anastrozole, being completely satisfied with the dermal healing result that the device provided.

Damage control surgery for grade IV blunt hepatic injury with multiple organ damage in a child: a case report

BackgroundIntra-abdominal hemorrhage caused by blunt hepatic injury is a major cause of morbidity and mortality in patients with abdominal trauma. Some of these patients require laparotomy, and rapid decision-making and life-saving surgery are essential. Damage control (DC) surgery is useful for treating children in critical situations. We performed this technique to treat an 8-year-old boy with grade IV blunt hepatic injury and multiple organ damage. This is the first report of the use of the ABTHERA Open Abdomen Negative Pressure Therapy System (KCI, now part of 3 M Company, San Antonio, TX, USA) for DC surgery to rescue a patient without neurological sequelae.Case presentationAn 8-year-old boy was brought to the emergency department of our hospital after being run over by a motor vehicle. He had grade IV blunt hepatic injury, thyroid injury, and bilateral hemopneumothorax. Although he was hemodynamically stable, the patient’s altered level of consciousness, the presence of a sign of peritoneal irritation, and suspicion of intestinal injury led us to perform exploratory laparotomy. As part of a DC strategy, we performed gauze packing to control hemorrhage from the liver and covered the abdomen with an ABTHERA Open Abdomen Negative Pressure Therapy System to improve the patient’s general condition. Eighteen days after admission, the patient was diagnosed with a biliary fistula, which improved with percutaneous and external drainage. He had no neurological sequelae and was discharged 102 days after injury.ConclusionThe DC strategy was effective in children with severe blunt hepatic injury. We opted to perform DC surgery because children have less hemodynamic reserve than adults, and we believe that using this strategy before the appearance of trauma triad of death could save lives and improve outcomes. During conservative management, it is important to adopt a multistage, flexible approach to achieve a good outcome.

New non-invasive device to promote primary closure of the fascia and prevent loss of domain in the open abdomen: a pilot study

BackgroundPrimary closure of the fascia at the conclusion of a stage laparotomy can be a challenging task. Current techniques to medialize the fascial edges in open abdomens entail several trips...

Clinical Applications and Benefits of Using Closed-Incision Negative Pressure Therapy for Incision and Surrounding Soft Tissue Management: A Novel Approach for Comorbid Wounds.

The principle of negative pressure technique dates back to the earliest civilizations; during the Roman era, the technique of using dome-shaped cupping glasses was used to create the suction needed to promote healing. This technique was used throughout the 19th century. In 1821, a British physician named Dr. Francis Fox invented the “glass leech” technique. Thereafter in 1952, an innovative approach was introduced to the treatment of serious, complex wounds through the use of sub-atmospheric or negative pressure known as “negative pressure wound therapy” (NPWT). Later, the “vacuum-assisted closure”, or VAC therapy system founded by Dr. Louis Argenta in 1990 revolutionized the advanced wound care market, and still remains the most clinically proven alternative for the treatment of complex, hard-to-heal wounds. These therapies utilize a foam dressing that is conformed to the wound bed. When sealed and placed under negative (vacuum) pressure, the system creates a unique wound-healing environment that has been shown to promote the wound-healing process, reduce edema, prepare the wound bed for closure, promote the formation of granulation tissue and remove infectious materials. The negative pressure therapy system addresses patient quality of life through an easy-to-use system designed to assist surgeons in the management and treatment of comorbid wounds, and open abdomen and other wound complications to help achieve primary fascial closure. Comorbidities can be defined as a concurrence of multiple chronic diseases in the same patient. Closed-incision negative pressure therapy (CINPT) has revolutionized the way in which caregivers treat the most serious, complex wounds or comorbid wounds. Wound healing can be achieved by the host’s innate and adaptive immune defence mechanisms as in an uninfected simple surgical incision through the skin or by combination of the host’s defence mechanisms and therapeutic modalities. It has been confirmed in some clinical researches that growth factors exert amazing effects on wound-healing promotion and skin function restoration without any obvious side effects. In this review, we have hypothesized a novel modality, focusing on the treatment of wound complications secondary to comorbidity by a combination of negative pressure therapy followed by a positive pressure infusion with growth factor concentrates.

Evaluation of closed incision negative pressure therapy systems on the closure of incisional space model.

The objective of this study was to compare the ability of foam dressing-based and non-foam-based closed incision negative pressure therapy (ciNPT) systems to close isolated incisional deficits in a tissue model. Similarly sized foam-based and non-foam-based absorbent ciNPT dressings were applied to ~36cm long, ~3mm and ~6mm wide simulated incisions in gel sheets covered with drape (n=6 dressings/group/experimental condition spread over three respective therapy units). Changes in incision widths were measured directly or with overlying solid gel sheeting (to mimic tissue resistance), at five equally spaced locations before, immediately upon and one hour after initiating negative pressure using associated therapy units. Foam-based ciNPT closed simulated incisions more often than non-foam-based ciNPT in all tested conditions (p<0.05). While foam-based ciNPT almost completely closed the ~3mm wide incisional spaces, unlike non-foam-based ciNPT, the biggest differences between the two groups were observed with the ~6mm incisional width, which allowed maximal inward-stretching of the appositional faces without complete closure. The additional gel layer blunted closure in both groups, but much more with non-foam-based ciNPT. There was minimal impact of negative pressure duration on these results. Foam-based ciNPT closed incisional widths in simulated tissue significantly more compared with non-foam-based ciNPT. Different ciNPT systems should not be considered necessarily equivalent in performance.

Evaluating a Single use Closed Incision Negative Pressure Therapy System over Closed Groin Incisions Following Vascular Surgery: Meta-analysis of Comparative Trials

Introduction: Surgical site complications pose a significant risk for patients. With groin incisions, surgical site complications may result in limb loss and increased risk of death, with rates as high as 44%. Closed incision negative pressure therapy (ciNPT) has been associated with decreased SSI rates in published literature A number of recent publications have compared SSI rates between ciNPT and traditional dressings following vascular surgery with groin incisions. This meta-analysis examines the effect of a the PREVENA™ Incision Management System (KCI, an ACELITY Company, San Antonio, TX) in reducing SSIs versus traditional dressings over closed groin incisions following vascular surgery. Methods: A systematic literature search using PubMed, OVID, EMBASE, and QUOSA was performed, focused for publications between January 1, 2005 and December 31, 2018. The literature search was limited to PREVENA™ Therapy use over closed groin incisions in randomized controlled trials (RCTs). Inclusion criteria included abstract or manuscript written in English, published or unpublished studies, RCTs, ciNPT usage over closed groin incisions in vascular surgery, comparison of ciNPT use and traditional dressings, study endpoint/outcome of SSI, and study population of >10. Characteristics of study participants, surgical procedure, type of dressing used, duration of treatment, incidence of SSI, and length of follow-up were extracted. Weighted risk ratios and 95% confidence intervals were calculated to pool study and control groups in each publication for analysis. Treatment effects were combined using Mantel-Haenszel risk ratios, and the chi-square test was used to assess heterogeneity. Results: A total of 615 articles were identified from the literature search. After removal of excluded studies and duplicates, 6 RCT studies were available for analysis. Four of the 6 RCTs restricted their inclusion criteria to patient deemed at high risk for SSI development. In these studies, a total of 362 patients received ciNPT, and 371 patients received traditional dressings (control group). SSI events occurred in 41 ciNPT patients and 107 control patients. The heterogeneity test was non-significant (p>0.05). The meta-analysis showed a highly significant effect in favor of ciNPT (RR= 0.41, 95% CI 0.29 to 0.57, p< 0.00001). One limitation of this study is the varying RCT inclusion/exclusion criteria, such as differences in procedure types, and patient populations (some RCTs restricted to patients at high risk for complications). Conclusion: For this meta-analysis, ciNPT usage demonstrated a statistically significant reduction in the incidence of SSI relative to traditional dressings in patients undergoing vascular surgery with groin incisions. Disclosure: Alexander Gombert received travel grants from Acelity. All further authors have nothing to disclose.

Using the method of negative pressure wound therapy in the treatment of necrotizing soft tissue infection complicated by severe sepsis

Relevance. One of the promising directions in the treatment of necrotizing forms of soft tissue infections is the application of the method of local negative pressure? Consequently objective assessment of the effectiveness of its use remains an urgent task of modern Surgery. Purpose of the study. Improve the results of treatment of patients with necrotizing soft tissue infection. Materials and methods. On the basis of the city center for the treatment of severe sepsis Research Institute of Emergency Care. I. I. Janelidze for the 2017–2018 year was treated 41 patients with NSTI, complicated by severe sepsis. The study group included 17 patients, the comparison group included 24 patients. The study group - patients in whom local negative pressure therapy (NPWT) was used for wound treatment and the control group – patients in whom surgical treatment of the infectious focus was conducted in the traditional way. Results. There was a statistically significant decrease in the level of mortality in the group of patients where negative pressure therapy systems were used. The lethal outcome in the comparison group (without NPWT) was 54%, in the study group (with NPWT) 24%. Conclusions. The use of local negative pressure therapy in the complex treatment of NIMT reliably reduces mortality.

Meta-analysis Comparing Outcomes of Two Different Negative Pressure Therapy Systems in Closed Incision Management.

Closed incision negative pressure therapy (ciNPT) is an emerging approach to managing closed incisions of patients at risk of postoperative complications. There are primarily 2 different commercially available ciNPT systems. Both systems consist of a single-use, battery-powered device and foam- or gauze-based peel-and-place dressing designed for closed incisions. These systems vary in design, and there are no data comparing outcomes between the 2 systems. We performed 2 separate meta-analyses to compare surgical site infection (SSI) rates postuse of (1) ciNPT with foam dressing (FOAM) versus conventional dressings and (2) ciNPT with multilayer absorbent dressing (MLA) versus conventional dressings. Seven articles and 2 abstracts met inclusion criteria in the FOAM group (n = 489) versus the control group (n = 489) in meta-analysis 1; 7 articles and 1 abstract met inclusion criteria in the MLA group (n = 532) versus the control group (n = 540) in meta-analysis 2. Meta-analysis 1 showed that patients in the control group were 3.17 times more likely to develop an SSI compared with patients in the FOAM group [weighted mean odds ratios of FOAM group versus control group was 3.17 (P < 0.0001) with the 95% confidence intervals of 2.17-4.65]. Meta-analysis 2 showed no significant difference in SSI rates between patients in the MLA group and patients in the control group [weighted mean odds ratios of MLA group versus control group was 1.70 (P = 0.08) with the 95% confidence intervals of 0.94-3.08]. Comparing outcomes of two different ciNPT systems with a common comparator (conventional dressings) may provide an interim basis for comparing ciNPT systems until further comparative evidence is available. More comparative research is required to determine outcomes in clinical practice.

Negative Pressure Wound Therapy with Instillation in the Septic Open Abdomen Utilizing a Modified Negative Pressure Therapy System.

BackgroundVarious treatment modalities are utilized to treat the open abdomen. The use of negative pressure wound therapy(NPWT)has been a great advancement and has become the preferred modality for temporary abdominal closure technique (TAC). Programmed instillation of the abdominal cavity with saline solution in conjunction with a commercial negative pressure system showed positive results in the management of severe abdominal sepsis in patients that were treated with an open abdomen. Severe abdominal sepsis continues to be an oftendifficult clinical problem for the general surgeon. The use of an open abdomen technique in this setting and the ideal TAC method continue to be debated. The failure to understand the biomechanical features/limitations of negative pressure devices are often contributing factors associated with therapeutic failures reported in the literature.ObjectivesTo describe the underlying principles behind negative pressure wound therapy with instillation in the context of abdominal sepsis, as well as its optimal usage in these conditions.MethodsA systematic review and two retrospective cohort studies, both published and unpublished performed by some of the authors were included to provide a basis form comparison between NPWT and NPWT-I outcomes in managing abdominal sepsis.ConclusionOur findings suggest that this technique appears to reduce morbidity, mortality, and hospital and critical care length of stay. This communication is intended to help inform general surgeons that manage complex abdominal infections on how to optimally apply this technique.

Management of the open abdomen: clinical recommendations for the trauma/acute care surgeon and general surgeon.

Traditionally, the surgical approach to managing abdominal injuries was to assess the extent of trauma, repair any damage and close the abdomen in one definitive procedure rather than leave the abdomen open. With advances in medicine, damage control surgery using temporary abdominal closure methods is being used to manage the open abdomen (OA) when closure is not possible. Although OA management is often observed in traumatic injuries, the extension of damage control surgery concepts, in conjunction with OA, for the management of the septic patient requires that the general surgeon who is faced with these challenges has a comprehensive knowledge of this complex subject. The purpose of this article is to provide guidance to the acute care and general surgeon on the use of OA negative pressure therapy (OA-NPT; ABTHERA™ Open Abdomen Negative Pressure Therapy System, KCI, an ACELITY Company, San Antonio, TX) for OA management. A literature review of published evidence, clinical recommendations on managing the OA and a case study demonstrating OA management using OA-NPT have been included.

Intra-abdominal Pressure Monitoring in Open Abdomen Management with Dynamic Abdominal Closure.

The importance of elevated intra-abdominal pressure (IAP) and abdominal compartment syndrome (ACS) have been recognized in critical care for its potential damaging effects. But, quantification of IAP values may be useful as a clinical tool for determining efficacy of coughing and straining for functional recovery of OA patients. We would like to evaluate IAP generated in an OA patient and the effect of negative pressure therapy (NPT) and dynamic abdominal closure systems (ABRA) on the IAP values at rest and during coughing and straining and compare those with IAP measurements of closed abdomen after standard open elective colorectal surgery (non-OA). Eight OA and eight non-OA patients were included in this study. OA patient with NPT and ABRA (OA + NA), OA patient without NPT and ABRA completely unbraced (OA-NA) (NA stands for NPT and ABRA), and non-OA patients underwent IAP measurements at rest, during coughing, and during straining via transurethral catheter. There was no difference in the mean of IAP measurement at rest in OA-NA (6.1mmHg), OA + NA (6.5mmHg), and non-OA (6.0mmHg) patients. During coughing, IAP of OA-NA, OA + NA, and non-OA patients were 11.5, 19.1, and 22.0mmHg and during straining, IAP of OA-NA, OA + NA, and non-OA patients were 11.5, 17.5, and 23.5mmHg, respectively. Application of NPT in conjunction with ABRA did not increase IAP at rest but provided significant IAP increase in OA + NA patients, when compared to OA-NA patients during coughing and straining. NPT in conjunction with ABRA offers the advantage of increase of IAP during coughing and straining.

Management of a Septic Open Abdomen Patient with Spontaneous Jejunal Perforation after Emergent C/S with Confounding Factor of Mild Acute Pancreatitis.

Introduction. We report the management of a septic Open Abdomen (OA) patient by the help of negative pressure therapy (NPT) and abdominal reapproximation anchor (ABRA) system in pregnant woman with spontaneous jejunal perforation after emergent cesarean section (C/S) with confounding factor of mild acute pancreatitis (AP). Presentation of Case. A 29-year-old and 34-week pregnant woman with AP underwent C/S. She was arrested after anesthesia induction and responded to cardiopulmonary resuscitation (CPR). There were only ash-colored serosanguinous fluid within abdomen during C/S. After C/S, she was transferred to intensive care unit (ICU) with vasopressor support. On postoperative 1st day, she underwent reoperation due to fecal fluid coming near the drainage. Leakage point could not be identified exactly and operation had to be deliberately abbreviated due to hemodynamic instability. NPT was applied. Two days later source control was provided by conversion of enteroatmospheric fistula (EAF) to jejunostomy. ABRA was added and OA was closed. No hernia developed at 10-month follow-up period. Conclusion. NPT application in septic OA patient may gain time to patient until adequate source control could be achieved. Using ABRA in conjunction with NPT increases the fascial closure rate in infected OA patient.

Management of the open abdomen using combination therapy with ABRA and ABThera systems.

The open abdomen is an increasingly used technique that is applied in a wide variety of clinical situations. The ABThera Open Abdomen Negative Pressure Therapy System is one of the most common and successful temporary closure systems, but it has limited ability to close the fascia in approximately 30% of patients. The abdominal reapproximation anchor system (ABRA) is a dynamic closure system that seems ideal to manage patients who may not achieve primary fascial closure with ABThera alone. We report on the use of the ABRA in conjunction with the ABThera in patients with an open abdomen. We retrospectively analyzed patients with an open abdomen managed with the ABThera and ABRA between January 2007 and December 2012 at the Halifax Infirmary, QEII Health Science Centre, Halifax, Nova Scotia. Sixteen patients had combination therapy using the ABRA and ABThera systems for treatment of the open abdomen. After removing patients who died prior to closure, primary fascial closure was achieved in 12 of 13 patients (92%). We observed a high rate of primary fascial closure in patients with an open abdomen managed with the ABThera system in conjuction with the ABRA. Applying mechanical traction in addition to the ABThera should be considered in patients predicted to be at high risk for failure to achieve primary fascial closure.

Care of the open abdomen after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for peritoneal surface malignancies.

A patient with a mucinous appendiceal cancer presents to the surgeon complaining of abdominal discomfort and nausea. Having undergone a prior right hemicolectomy, the patient has been disease free and on surveillance with clinical and carcinogenic antigen (CEA) monitoring. The CEA was noted to be elevated and a computed tomography scan revealed peritoneal nodules throughout the abdomen with a presumptive diagnosis of pseudomyxoma peritonei (progressive peritoneal implants from a mucinous primary). Several therapeutic options were offered and the patient selected to undergo cytoreductive surgery (CRS) with the potential to receive hyperthermic interoperative chemotherapy (HIPEC). Extensive resection was performed, including removal of the entire greater omentum, partial gastrectomy, and total pelvic exenteration with end colostomy and ileal conduit. Reassessment of the peritoneal cavity after the resections revealed almost complete cytoreduction. HIPEC was performed with mitomycin C and, after drainage and abdominal washing, the intestinal segments were anastomosed and the abdominal wall closed. Seven days postoperatively, an acute abdomen with septic shock developed as a result of a leak from the ileocolonic anastomosis. The patient returned to the operating room and an exploratory laparotomy, a small bowel resection, a resection of the ileocolonic anastomosis, and an abdominal washout were performed. Edema of the bowel caused by peritonitis resulting from the anastomotic leak necessitated delayed closure of the abdominal wall. A temporary abdominal closure using the ABThera™ Open Abdomen Negative Pressure Therapy system was applied and the abdomen was eventually closed.

The open abdomen: temporary closure with a modified negative pressure therapy technique.

The most common indications for an open abdomen (OA) are abdominal compartment syndrome, damage control surgery, diffuse peritonitis and wound dehiscence, and often require a temporary abdominal closure (TAC). The different TAC methods that are currently available include skin closure techniques, mesh products and negative pressure therapy (NPT) systems. For this study, we retrospectively reviewed records of 115 OA patients treated with the commercially available NPT systems (V.A.C.(®) Abdominal Dressing System and ABThera™ Open Abdomen Negative Pressure Therapy System) using a new method of applying the system-the narrowing technique-over a 5-year period. Endpoints included fascial closure and 30-day mortality rates and presence of enteroatmospheric fistulas. Secondary closure of the fascia was obtained in 92% (106/115) of the patients with a mortality rate of 17% (20/115) and a fistula rate of 3·5% (4/115). The use of the narrowing technique to apply NPT may explain the high closure rates observed in the patient population of this study. Further studies are necessary to compare the different methods and to evaluate the long-term outcomes.

Efficacy and safety of active negative pressure peritoneal therapy for reducing the systemic inflammatory response after damage control laparotomy (the Intra-peritoneal Vacuum Trial): study protocol for a randomized controlled trial

BackgroundDamage control laparotomy, or abbreviated initial laparotomy followed by temporary abdominal closure (TAC), intensive care unit resuscitation, and planned re-laparotomy, is frequently used to manage intra-abdominal bleeding and contamination among critically ill or injured adults. Animal data suggest that TAC techniques that employ negative pressure to the peritoneal cavity may reduce the systemic inflammatory response and associated organ injury. The primary objective of this study is to determine if use of a TAC dressing that affords active negative pressure peritoneal therapy, the ABThera Open Abdomen Negative Pressure Therapy System, reduces the extent of the systemic inflammatory response after damage control laparotomy for intra-abdominal sepsis or injury as compared to a commonly used TAC method that provides potentially less efficient peritoneal negative pressure, the Barker’s vacuum pack.Methods/DesignThe Intra-peritoneal Vacuum Trial will be a single-center, randomized controlled trial. Adults will be intraoperatively allocated to TAC with either the ABThera or Barker’s vacuum pack after the decision has been made by the attending surgeon to perform a damage control laparotomy. The study will use variable block size randomization. On study days 1, 2, 3, 7, and 28, blood will be collected. Whenever possible, peritoneal fluid will also be collected at these time points from the patient’s abdomen or TAC device. Luminex technology will be used to quantify the concentrations of 65 mediators relevant to the inflammatory response in peritoneal fluid and plasma. The primary endpoint is the difference in the plasma concentration of the pro-inflammatory cytokine IL-6 at 24 and 48 h after TAC dressing application. Secondary endpoints include the differential effects of these dressings on the systemic concentration of other pro-inflammatory cytokines, collective peritoneal and systemic inflammatory mediator profiles, postoperative fluid balance, intra-abdominal pressure, and several patient-important outcomes, including organ dysfunction measures and mortality.DiscussionResults from this study will improve understanding of the effect of active negative pressure peritoneal therapy after damage control laparotomy on the inflammatory response. It will also gather necessary pilot information needed to inform design of a multicenter trial comparing clinical outcomes among patients randomized to TAC with the ABThera versus Barker’s vacuum pack.Trial registrationClinicalTrials.gov identifier http://www.clicaltrials.gov/ct2/show/NCT01355094

Prospective Study Examining Clinical Outcomes Associated with a Negative Pressure Wound Therapy System and Barker’s Vacuum Packing Technique

BackgroundThe open abdomen has become a common procedure in the management of complex abdominal problems and has improved patient survival. The method of temporary abdominal closure (TAC) may play a role in patient outcome.MethodsA prospective, observational, open-label study was performed to evaluate two TAC techniques in surgical and trauma patients requiring open abdomen management: Barker’s vacuum-packing technique (BVPT) and the ABTheraTM open abdomen negative pressure therapy system (NPWT). Study endpoints were days to and rate of 30-day primary fascial closure (PFC) and 30-day all-cause mortality.ResultsAltogether, 280 patients were enrolled from 20 study sites. Among them, 168 patients underwent at least 48 hours of consistent TAC therapy (111 NPWT, 57 BVPT). The two study groups were well matched demographically. Median days to PFC were 9 days for NPWT versus 12 days for BVPT (p = 0.12). The 30-day PFC rate was 69 % for NPWT and 51 % for BVPT (p = 0.03). The 30-day all-cause mortality was 14 % for NPWT and 30 % for BVPT (p = 0.01). Multivariate logistic regression analysis identified that patients treated with NPWT were significantly more likely to survive than the BVPT patients [odds ratio 3.17 (95 % confidence interval 1.22–8.26); p = 0.02] after controlling for age, severity of illness, and cumulative fluid administration.ConclusionsActive NPWT is associated with significantly higher 30-day PFC rates and lower 30-day all-cause mortality among patients who require an open abdomen for at least 48 h during treatment for critical illness.