Introduction. Emergency laparotomy has become an increasingly more frequent and expensive general surgery procedure in terms of cost and resource utilization. Primary fascial closure at the index procedure may not be feasible in many patients, requiring use of the open abdomen (OA) technique. Patients with OA are most often managed with temporary abdomen closure (TAC). Open abdomen negative pressure therapy (OA-NPT) has been shown to be an effective TAC technique, which facilitates re-exploration, protects visceral organs, mitigates fascial retraction, prevents loss of abdominal domain, and provides effective volumetric abdominal fluid management. Objective. This study assessed the clinical use and outcomes of a next-generation perforated polyurethane foam dressing that has been developed for use with OA-NPT. Materials and Methods. The authors evaluated a next-generation OA-NPT foam dressing to provide TAC in 4 patients who required OA management. Two surgeons at different facilities exercised their independent surgical discretion in selecting the patients who would receive the next generation OA-NPT foam dressing. Surgical interventions to resolve the underlying pathology were completed using the OA technique. Postoperatively, all patients had intermittent urinary bladder pressures recorded as an indirect method for approximating intra-abdominal pressure (IAP) and to monitor clinical evidence of intra-abdominal hypertension (IAH) or abdominal compartment syndrome. Results. In these patients, primary fascial closure was achieved and no appreciable increase in IAP was noted. No gastrointestinal complications related to the next generation perforated OA-NPT foam dressing were noted. Conclusions. Based on the authors' clinical assessment of the 4 patients who required OA management, the new, perforated OA-NPT foam dressing was effective in providing increased medial tension and contraction without an appreciable increase in IAP. 

Emergency laparotomy represents an increasingly regular and expensive general surgery procedure in terms of cost and resource utilization.¹ In the United States, laparotomy is among 7 emergency general surgical procedures that account for approximately 80% of all admissions, deaths, complications, and inpatient costs.²  Due to the severity of the presenting complex surgical pathology, leaving the abdominal cavity open until definitive surgical resolution can be safely achieved is often required.^3,4

An optimal strategy for temporary abdominal closure (TAC) should entail a modality that protects the abdominal contents, provides active removal of cytokine-rich intra-abdominal fluid from the abdominal cavity, and aids in medial traction along the fascial edges. ⁴ Temporary abdominal closure techniques and devices are divided into passive or active modalities. Passive modalities, such as the Bogotá bag, are characterized by simplicity, availability, rapid application, and low cost, but they are limited by an inability to manage intra-abdominal fluids effectively and promote delayed primary fascial closure (PFC).^4,5 Active modalities employ sub-atmospheric pressure, which enhances medial traction along the fascial edges, thereby decreasing lateral retraction, and effectively removing fluid from the abdominal cavity.⁴ 

Active TAC modalities may be further divided into the improvised Barker’s technique and commercially available open abdomen-negative pressure therapy (OA-NPT).^4,6 The latter technique, pioneered by Miller et al,⁷ developed the use of a fenestrated polyethylene protective layer over visceral organs, which were tucked under the fascial edges, as well as the use of a commercially available polyurethane foam as opposed to sterile surgical towels.^4,6,7 Miller et al⁷ and Frazee et al⁸ reported reduced planned ventral hernia rates and higher PFC rates in the OA-NPT group relative to Barker’s technique (89% vs 59%).^4,7,8

In 2009, the U.S. Food and Drug Administration cleared a commercially available OA-NPT system (ABTHERA Open Abdomen Negative Pressure Therapy; KCI, now part of 3M). Reported advantages of commercially available OA-NPT are an all-inclusive sterilely packaged system, easy portability from the operating room (OR) to the intensive care unit (ICU), and volumetric monitoring to measure fluid output.^4,7,8,9 More recently, a next generation perforated polyurethane foam dressing (ABTHERA ADVANCE Open Abdomen Dressing; KCI, now part of 3M) has been developed for OA management that provides increased medial tension and contracts medially in a more effective manner relative to the previous iteration of OA-NPT perforated foam dressing. This pilot study describes the authors’ initial experience and PFC rates with the use of the next generation OA-NPT dressing in 4 cases of varying complexity. 

Open abdomen negative pressure therapy and a next generation OA-NPT foam dressing (Figure 1) were used to provide TAC at all the index operations. All patients underwent damage control surgery, as described by Rotondo et al,¹⁰ for the resuscitation of trauma patients. 

Two surgeons at different facilities exercised their independent surgical discretion in selecting the TAC patients (Table) who would receive the next generation OA-NPT foam dressing. All patients underwent a computed tomography (CT) scan of the abdomen prior to the initial laparotomy. Oral or intravenous antibiotics were administered perioperatively as needed. Lavage of the abdominal cavity was performed with either normal saline and/or a topical wound cleansing solution of hypochlorous acid (VASHE Wound Solution; Urgo Medical North America). Surgical interventions to resolve the underlying pathology were completed using the OA technique. Post-operatively, all patients had intermittent urinary bladder pressures recorded as an indirect method for approximating intra-abdominal pressure (IAP) and monitoring clinical evidence of intra-abdominal hypertension (IAH) or abdominal compartment syndrome.

Surgical technique
A protective layer (ABTHERA Fenestrated Visceral Protective Layer; KCI, now part of 3M) was applied over visceral organs with the margins of the protective layer extending toward the paracolic gutters. A sub-peritoneal tuck technique (Figure 2) was used for the application of the next generation perforated foam dressing. The dressing was tucked a minimum of 2 cm underneath the fascial edges. An occlusive drape (ABTHERA Drape; KCI, now part of 3M) was applied over the next-generation OA-NPT foam dressing, and OA management was achieved by the OA-NPT unit (V.A.C.ULTA 4 Therapy System; KCI, now part of 3M) applying subatmospheric pressure (-125 mm Hg) to the sealed abdominal/laparotomy wound. Upon completion of the OA procedure, patients were transferred to the surgical ICU/shock trauma unit for recovery. If necessary, additional exploratory laparotomies were performed as needed.

Case 1

A 69-year-old male presented to the emergency department (ED) with complaints of abdominal pain and a tense and distended abdomen. His previous medical history included stage 4 lung cancer, stomach cancer, and previous treatment with chemotherapy and radiation therapy. Previous surgical procedures included the placement of an internal carotid and a coronary artery stents, cervical spine surgery, and skin biopsy. Hematological assays noted an elevated white blood cell count and a clinical picture suggestive of early sepsis/septic shock. A thoracic CT scan revealed a large left pleural effusion, and a CT scan of the abdomen confirmed pneumoperitoneum. 

The patient was taken to the OR and underwent an exploratory celiotomy (Figure 3A). A 0.7 mm perforated duodenal ulcer was found with extensive peritoneal contamination, which required abdominal debridement and washout. Upon inspection, the gallbladder and appendix were noted to be inflamed, and given the risk for delayed cholecystitis or appendicitis, an appendectomy and cholecystectomy were performed without any complications and with minimal additional operative time. After the closure of the perforated duodenum, irrigation of the abdomen was performed using 3 L of normal saline (NS) followed by 2 L of hypochlorous acid solution with a 10-minute dwell time. Temporary abdominal closure was achieved via OA-NPT (-125 mm Hg) using the next-generation OA-NPT foam dressing. The 3 layers of OA-NPT were applied immediately postoperatively. 

Following the initial visit to the OR, the patient was transferred to the surgical ICU/shock trauma unit. Abdominal compartment pressures were measured. The patient was tachycardic, hypotensive, and demonstrated low central venous pressure despite being administered 4 L of intravenous fluids in the ED and intraoperatively. The patient was aggressively resuscitated with crystalloids and 25% albumin. Broad spectrum antibiotics were initiated. 

On postoperative day (POD) 3, the patient was returned to the OR for an exploratory celiotomy, revision and repair of the contained duodenal leak, and omental mobilization. The next generation OA-NPT foam dressing was applied (Figure 3B); no appreciable increase in IAP was noted. 

A third exploratory celiotomy was performed on POD 4, no clinical leak was seen and careful inspection of the abdominal cavity showed that no fibrin deposition or abscess were noted. Abdominal washout with 0.9NS and hypochlorous acid solution with a 10-minute dwell time, placement of adhesion barrier membrane, and primary abdominal closure were done. The clean, closed incision was managed for 7 days with closed incision negative pressure therapy (ciNPT; PREVENA Incision Management System; KCI, now part of 3M) (Figure 3C). 

The patient continued to improve and was discharged to hospice on POD day 12, with stable vital signs, tolerating a general diet and ambulation.

Case 2

A 24-year-old female presented to the ED with complaints of severe abdominal pain, distention, lower back pain, dizziness, and a near syncopal episode. The patient was noted to be febrile, tachycardic (140 beats per minute [bpm]), and hypotensive (systolic blood pressure at 60’s mm Hg). On physical examination, she had a distended abdomen and left lower quadrant tenderness. A continuous wave, obstetrical Doppler ultrasound revealed an early intrauterine pregnancy (11-week gestation) and a fetal heart rate of 135 bpm. The patient had leukocytosis (18.9) and a neutrophil count of 84. A Focused Assessment with Sonography for Trauma (FAST) was done, and free fluid in the pelvis and right upper quadrant was noted. After rapid intravenous fluid administration in the ED, the patient was stabilized, and an abdominal CT scan revealed dilated loops of small bowel with diffuse thickness, consistent with edema, and a fluid-filled abdominopelvic cavity. She was taken to the OR for a diagnostic laparoscopy (Figure 4A), which was converted to an open exploration after scope insertion revealed bloody ascites and loops of necrotic small bowel. 

An internal hernia was noted with a small bowel volvulus. This required intestinal detorsion and prompted a resection of 300 cm of ischemic small bowel. The bowel was left in discontinuity and an OA-NPT dressing was placed within the OA for TAC using the technique previously described (Figure 4B). No appreciable increase in IAP was noted.

The patient was admitted to the surgical ICU for management of an OA, pain control, metabolic acidosis, septic shock, and hypovolemia with fetal demise. On POD 2, the patient returned to the OR for abdominal lavage, a stapled, jejunal-colonic, end-to-end anastomosis, appendectomy, placement of a nasoenteric tube, and PFC. 

The patient was discharged home on POD 7, with good pain control, tolerating a regular diet, ambulation, and twice daily wet-to-dry dressing changes on her abdomen. One-week post-discharge, the patient was evaluated at a follow-up appointment with fascial suture line that was intact and no clinical evidence of infection (Figure 4C).

In these patients, PFC was achieved and no appreciable increase in IAP was noted. No gastrointestinal complications related to the next generation perforated OA-NPT foam dressing were noted. This study reiterates previous findings that devices that can exert continuous medial traction along the fascial edges by administering subatmospheric pressure are the preferred method for attaining TAC.¹¹ 

Open abdomen-NPT affords ease of re-exploration, protection of visceral organs, mitigates fascial retraction and loss of domain, and provides volumetric management of intra-abdominal fluid.^4,7-9,11-14 Effectiveness is based on the tri-layer dressing consisting of a fenestrated foam-filled drape for visceral shielding and edematous fluid removal from paracolic gutters, reticulated open-cell foam to serve as a manifold for negative pressure, and an occlusive adhesive drape to sequester the abdominal cavity and ensure continuous negative pressure to the focus area. Compared with the Bogotá bag, OA-NPT allows for effective volumetric management of fluid.^11,12 In a bench study utilizing an in vitro test model to simulate the physical conditions of OA, 3 OA management (OAM) systems (ie, Barker’s vacuum packing technique [BVT], conventional negative pressure wound therapy, and commercially available OA-NPT) were evaluated for pressure mapping and the efficiency of fluid extraction. Open abdomen-NPT was revealed to be the most effective as the visceral protective layer enhanced pressure manifolding to regions immediately external of the edge of manifolding material and most distal to the source of subatmospheric pressure.¹³

In a prospective, multicenter cohort study, Jensen et al¹⁴ reported that OA-NPT was safe and effective in a cohort of 74 consecutive patients with abdominal catastrophes and demonstrated a low rate of complications. Complete secondary closure of the fascia without mesh usage immediately following OA-NPT was achieved in 84.3% of patients.¹⁴ 

In a retrospective study by Frazee et al,⁸ OA-NPT demonstrated greater success with PFC after OAM relative to BVT (33/37 [89%] vs 22/37 [54%]; P < .05). Given the difference in closure rates between commercially available OA-NPT and BVT, it was estimated that 11 ventral hernias could be prevented at a cost savings of $176 000. The higher cost of commercially available OA-NPT was purportedly counterbalanced by positive patient outcomes and cost-savings resultant of successful PFC.⁸ 

In a prospective study of 168 patients who received at least 48 hours of BVT (n= 57) or OA-NPT (n = 111), Cheatham et al¹⁵ compared clinical outcomes using BVT or OA-NPT. The 30-day PFC rate was 69% versus 51% for OA-NPT and BVT, respectively (P = .03). The 30-day all-cause mortality was 14% for OA-NPT and 30% for BVT (P = .01).¹⁵ Open abdomen-NPT was independently associated with a significantly improved 30-day survival among patients who were administered greater than or equal to 48 hours of consistent OAM.¹⁵ 

Conversely, in an analysis of 83 OA patients (OA-NPT = 65; BVT = 18), Montori et al¹⁶ found no difference in terms of time to closure between patients receiving OA-NPT and patients receiving BVT (75.4% vs 93.8%; P = .10).¹⁶ However, compared with BVT, treatment with OA-NPT demonstrated lower rates for intra-hospital mortality (27.7% vs 50%; P = .07) and overall mortality (37.1% vs 66.7%; P = .07).¹⁶

In a retrospective analysis of multiple TAC modalities that included 239 patients, the role of initial TAC on eventual PFC and preempting loss of domain was evaluated.¹⁷ Temporary abdominal closure methods included primary skin closure (n= 138; 57.7%), Bogotá bag (n= 60; 25.1%), OA-NPT (n= 36; 15.1%) and BVT (n= 5; 2.1%). Patients receiving skin-only closure had significantly higher rates of PFC and lower hospital mortality, but also significantly lower mean lactate, base deficit, and requirement for massive transfusion. Primary skin closure demonstrated the highest rate of PFC, which was significant relative to Bogotá bag usage (P = .001); however, when adjusted for confounding covariates, OA-NPT was associated with an increased capacity to attain PFC.¹⁷ Open abdomen-NPT was the preferred modality for TAC for damage control surgery in trauma cases.¹⁷

The medial traction provided by the innovative design of the next generation OA-NPT dressing afforded an advantage over the previous iteration of perforated OA-NPT foam. The present authors concur that placing the next generation OA-NPT foam dressing underneath the fascial edges for a minimum of 2 cm, known as the Fernández Tuck Technique, appeared to enhance the inherent biomechanical properties of OA-NPT. In the present authors’ experience, the more collapsible configuration of the foam dressing helped to achieve greater medial traction and PFC in these 4 patients. The increased medial tension relative to the previous iteration of OA-NPT foam dressing improved approximation of the fascial edges, minimizing fascial retraction and the loss of abdominal domain.

The limitations of the present study are those generally associated with case series (eg, small sample size). As such, there were no controls for comparison to evaluate the effectiveness of the perforated OA-NPT foam dressing relative to the prior iteration of OA-NPT foam dressing or alternative modalities of OAM. Additionally, the authors describe the Fernández Tuck Technique for applying the perforated OA-NPT foam dressing; however, to the researchers’ knowledge, there is no literature that considers alternative configurations to the application of prior OA-NPT foam dressings. It is noted that the more collapsible configuration of the next-generation OA-NPT foam dressing makes the Fernández Tuck Technique more effective as compared with its use with the prior iteration of the OA-NPT foam dressing.

In the authors’ experience, the innovative design of the next generation OA-NPT foam dressing increased medial tension and promoted PFC in the described patients. Additionally, tucking the edges of the next generation OA-NPT foam dressing under the fascia helped facilitate approximation of the wound edges. Robust statistical analysis is necessary to determine clinical efficacy and cost effectiveness for health economic studies. 

The authors thank Willie M. Heard III, PhD (3M), for manuscript preparation and editing.

Authors: Luis G. Fernández, MD, FACS, FASAS, FCCP, FCCM, FICS^1-5; and Marc R. Matthews, MD, MS, MCG, FACS⁶

Affiliations: ¹Professor of Surgery, Dept. of Surgery University of Texas Health Science Center, Tyler, TX; ²Adjunct Clinical Professor of Medicine and Nursing, University of Texas, Arlington, TX; ³Adjunct Clinical Assistant Professor, Dept. of Medical Education Health Science Center; ⁴Adjunct Clinical Assistant Professor, Dept. of Physician Assistant Studies, School of Health Professions, University of North Texas, Fort Worth, TX; ⁵Medical Director, Trauma Wound Care, UT Health East, Tyler, TX; ⁶Surgical Attending, The Arizona Burn Center, Maricopa Integrated Health System, Phoenix, AZ

Correspondence: Luis G. Fernández, MD, FACS, FASAS, FCCP, FCCM, FICS, Professor of Surgery, Dept. of Surgery, UT Health East Texas Physicians Tyler-Trauma Surgery, 1020 E. Idel St., Tyler, TX 75701; Office: 903-535-2902; Fax: 903-535-9217; thebigkahuna115@gmail.com

Disclosure: Dr. Fernández and Dr. Matthews are consultants for 3M.

Authors’ contributions: Dr. Fernández was responsible for study design, performed surgical procedures, and revised the manuscript. Dr. Matthews was responsible for study design, performed surgical procedures, and reviewed the manuscript. All authors have read and approved the final document.