Fascia-to-Fascia Closure with Abdominal Topical Negative Pressure for Severe Abdominal Infections: Preliminary Results in a Department of General Surgery and Intensive Care Unit

Abstract

Background:

Vacuum-assisted fascial closure (VAFC-KCI^®) of an open abdomen is one of the latest methods.

Methods:

A prospective observational study was performed with medical records of nine patients who had been treated by abdominal VAFC-KCI^® from March 2006 to October 2007 in the Department of Surgical Sciences, University of Insubria. The mean Acute Physiology and Chronic Health Evaluation II and Sequential Organ Failure Assessment scores were 22.62 and 10.62, respectively. All patients had abdominal compartment syndrome and a sepsis source that was difficult to control.

Results:

All patients survived. The mean duration of open abdomen was 22.7 days (range, 3–50 days). Primary fascial closure was possible in six patients (66%), with a closure rate of 100% when early control of the infectious source was possible (Group A) but only 40% in patients with difficult and delayed control of infection (Group B). The mean durations of open abdomen in the two groups were statistically different: 8.5 days for Group A vs. 34.2 days for Group B (p < 0.005; Student t -test).

Conclusions:

In our brief experience, VAFC-KCI^® seems to be associated with a high fascial closure rate. The complexity of the management of abdominal source control has a role in the success of primary fascial closure. The VAFC-KCI^® system seems to contribute positively in fascia-to-fascia abdominal closure in cases of severe abdominal infection, in particular when early surgical source control is obtained.

Today, the open abdomen is a common clinical challenge in surgical and intensive care units (ICUs). Open abdominal management should be considered after laparotomy in patients who need early re-exploration or when conventional closure would result in unacceptable abdominal wall tension [1].

Recognition of the role of intra-abdominal hypertension in the pathophysiology of visceral hypoperfusion and multiple organ failure after trauma, burns, pancreatitis, and intensive resuscitation has induced surgeons to make more use of decompressive laparotomy and consequently laparostomy [2 –6]. Damage control surgery characterized by intraoperative metabolic derangements such as acidosis or coagulopathy is another procedure in which there are benefits from an open abdomen [7]. In severe intra-abdominal infection or severe acute pancreatitis, when a single laparotomy cannot control the source of infection effectively, an open abdomen facilitates repeated debridement and effective drainage and prevents the development of abdominal hypertension [8,9].

Once the decision is made to institute an open abdominal procedure, it is necessary to select a suitable temporary abdominal closure [10 –12]. Several methods have been described; the choice of a specific option should be tailored to the clinical circumstances. Personal preference and local experience could have a major impact; in any case, this choice should consider that the permanent fascial closure of the abdominal wall is the goal for all patients with open abdominal management [13 –18].

Several techniques of temporary closure have been reported, some of which contemplate the use of negative pressure. In 1986, Schein et al. reported the first use of an open abdomen plus “negative pressure.” A “sandwich technique” was the method suggested to obtain closure of the abdominal cavity [19]. In 1993, Wittmann et al. presented another method to facilitate temporary abdominal closure [20]. A few years later, Brock et al. introduced the vacuum pack, a technique in which the visceral block is wrapped in a polyethylene sheet, then covered with a surgical towel [21]. More recently, in 1999, Argenta and Morykwas introduced a new device for vacuum-assisted wound management: VAFC-KCI^® (Kinetic Concepts, Inc., San Antonio, TX [KCI]) [22]. This method replaces the absorptive towel of the vacuum pack with a coated polyurethane sponge and introduces the application of controlled sub-atmospheric pressure to the incision [22]. All these methods use topical negative pressure, facilitate removal of fluid collections, reduce edema, and accelerate healing by granulation. Furthermore, they should exert continuous traction on fascial edges and consequently promote primary abdominal wall closure [2,7,23 –25].

Use of the VAFC-KCI^® in the experience of Miller et al. and Cothern et al. was associated with a fascial closure rate of 88% and 100%, respectively [23,26]. In a group of 116 trauma and 142 general and vascular surgery patients, Barker et al. described 154 patients (68.1%) who underwent primary fascial closure [7]. Those investigators reported that primary fascial closure was performed more frequently in patients requiring a single vacuum pack than in those requiring multiple packs (89.4% vs. 53.9%). Fascial closure was delayed until completion of the planned intra-abdominal procedures. For patients with multiple vacuum packs, the mean number of revisions of the abdominal cavity was 3.6 ± 3.1 (range, 2–23). The patients most likely to undergo primary fascial closure are those who can be closed during the first week after initial celiotomy. We evaluated our early experience with open abdominal management in patients with abdominal sepsis and the use of abdominal topical negative pressure, with particular regard to the success of fascia-to-fascia closure.

Patients and Methods

From March 2006 to October 2007, all patients undergoing open abdomen and topical negative pressure management in the Department of Surgical Sciences–University of Insubria were studied prospectively. Six of the nine patients were referred to our department from other institutions, where they had undergone to initial abdominal treatment (Table 1). For all patients, the indication for re-laparotomy was severe peritonitis, persistent infection of the abdominal cavity, and the presence of primary abdominal compartment syndrome.

Table 1.

Patients Treated with Open Abdomen, 2006–2007

Patient no.	Age (years)	Disease
1	67	Rectal perforation
2^a	35	Spontaneous retroperitoneal abscess
3^a	69	Diverticulitis
4	79	Segmental bowel necrosis
5	46	Multiple bowel perforations
6^a	50	Colonic anastomotic leakage
7^a	69	Colonic anastomotic leakage
8^a	23	Liver abscess and gallbladder perforation
9^a	55	Colonic anastomotic leakage

Referred from another hospital.

Demographic data, including age, gender, duration of open abdomen, local complications, and type of temporary and definitive abdominal wall closure, were collected. Severity of disease was evaluated by Acute Physiology and Chronic Health Evaluation (APACHE) II and Sequential Organ Failure Assessment (SOFA) scores [27,28] calculated at the time of admission to the intensive care unit (ICU). Intra-abdominal pressure (IAP) was determined by the routine measurement of urinary bladder pressure. The success of fascia-to-fascia abdominal closure, duration of open abdomen, and length of hospital stay were calculated. Also, 12-mo follow-up data were recorded. All patients were operated on by RD, who also was the supervisor throughout the treatment, and daily management was performed by the other authors; GM co-ordinated resuscitation and management of organ dysfunction during the patients' stay in the ICU.

All patients received the same abdominal management. During revisions, a complete bowel separation was made and all infectious foci within the abdominal cavity were debrided until source control was complete.

For all patients, temporary closure was achieved with VAFC® (KCI, San Antonio, TX). The abdominal dressing consists of three layers. The deepest layer is a thin sponge covered by a double-perforated non-adherent plastic sheet placed over the peritoneal viscera and beneath the peritoneum. This material prevents adhesions of the viscera and decreases damage attributable to repeated exploration. The second layer consists of sterile polyurethane sponge (Granu Foam^®, KCI). The edges of the sponge are positioned between the perforated polyethylene sheet and the parietal peritoneum. Placement of sponge below the anterior parietal peritoneum prevents the viscera from protruding through the abdominal wall defect. In fact, when negative pressure is applied to the dressing, this material becomes semirigid, providing additional protection for the intra-abdominal contents. The third component consists of an adhesive polyethylene drape that completes the vacuum seal. An aspiration system is placed over this third component. The drain is connected to a source at −50 to −150 mm Hg of pressure. Aspiration ensures fluid removal and adhesion of the sponge of the external drape to the skin (Fig. 1).

FIG. 1.

Steps in placement of vacuum-assisted fascial closure system.

Re-explorations were performed every 48 h. At the end of abdominal exploration, the non-adherent polyethylene sheet and the sponge were changed. The polyethylene sheet that formed the deepest layer of the dressing serves as a physical barrier between the viscera and the abdominal natural or artificial wall (Fig. 2). It prevents adhesions between the bowel and the abdominal wall and is necessary until complete debridement and effective source control are obtained.

FIG. 2.

Polyethylene sheet (deepest layer) creates physical barrier between viscera and abdominal wall (natural or artificial).

Primary definitive closure, fascia-to-fascia suture, was the principal end point of our study. The duration of open abdomen in relation to source control was the secondary end point of our research. The control of sepsis was considered arbitrarily to be “early” (Group A) when the abdomen was open for less than two weeks and “delayed” (Group B) when the time to source control exceeded 14 days.

Values are presented as median, mean with standard deviation, or range. The student t-test was used for comparison of the duration of open abdomen in groups A and B. Significance was set at p < 0.05 for all tests. The study was approved by the ethics committee of the University of Insubria.

Results

The nine patients, with a mean age of 54.7 years (range, 23–79 years), presented with multiple organ dysfunction syndrome secondary to persistent infection of the abdominal cavity. The initial mean APACHE II and SOFA scores were 22.62 and 10.62, respectively (Table 2). The patients all were admitted to the ICU because of the severity of their conditions. All of them had abdominal compartment syndrome; the mean intra-abdominal pressure the day before decompression was 24 cm H₂O. A decrease in abdominal pressure was evidenced after laparotomy and during progression of open-abdomen management.

Table 2.

Severity of Disease

	Mean (range)
Acute Physiology and Chronic Health Evaluation II score	22.62 (12–36)
Sequential Organ Failure Assessment score	10.62 (4–21)
Intra-abdominal pressure (cm H₂O)	24 (12–36)

The mean duration of open abdominal treatment was 22.7 days (range, 3–50 days). Every 48 h, a re-exploration of the abdominal cavity and a change of dressing was done by senior surgeons. Forty-six re-operations were executed, the majority in an operating room. However, when the clinical condition was so severe that transfer was considered a risk, dressing change and re-exploration were performed in the ICU. A mean of 10.1 changes of dressing per patient was made (range, 1–24). The adjustment of abdominal pressure and control of infection were the principal determinants of the time to abdominal closure. Clinical improvement and disappearance of multiple organ dysfunction syndrome associated with a computed tomography (CT) scan that demonstrated absence of residual abscesses identified the resolution of abdominal sepsis.

Three local complications were observed: Two cases of hemorrhages and one fistula. One patient presented with intestinal perforation and bleeding contemporaneously. The enteric fistula closed spontaneously after ten days of non-operative management. In this patient, open management was continued, but the topical negative pressure was reduced to 50 mm Hg. Bleeding was the other complication observed; compression with abdominal pads and temporary interruption of negative pressure led to prompt control. No patient died, and all returned to a normal life.

Primary direct fascia-to-fascia closure was possible in six patients (66%). Definitive closure was possible for all patients with early control of abdominal infection (Table 3). By contrast, when source control was delayed, primary wound closure by fascia-to-fascia suture was executed in only 40% of cases.

Table 3.

Treatment Details and Outcomes

Patient no.	Source control	Days of VAFC®	Local complications	Closure
1	Delayed	41	No	Primary
2	Early	9	No	Primary
3	Delayed	20	No	Skin graft
4	Early	3	No	Primary
5	Delayed	50	No	Delayed
6	Delayed	40	Bleeding	Delayed
7	Delayed	20	Bleeding and duodenal fistula	Primary
8	Early	13	No	Primary
9	Early	9	No	Primary

VAFC = Vacuum-Assisted Fascial Closure.

The mean time to fascial closure was 8.5 and 34.2 days, respectively, for Groups A and B (p < 0.005) (Table 4). A 12-mo follow-up revealed that no incisional hernias were present in six patients (four patients with early control of sepsis and a primary abdominal closure and two patients with delayed control of sepsis but primary closure of the abdominal wall). One patient had a ventral hernia. Two patients with delayed source control of sepsis and therefore delayed abdominal wall closure presented small abdominal defects.

Table 4.

Primary Closure Success in Relation to Timing of Control of Septic Source

Early septic control?	Mean days to closure	Primary closure success (%)
Yes (Group A)	8.5	100
No (Group B)	34.20	40

P < 0.005; Student t-test.

Discussion

Planned re-laparotomy, re-laparotomy on demand, and open management are current strategies for the treatment of severe peritonitis [35,36]. The evaluation of specific approaches to source control of infection is difficult. Clinical trials are not particularly useful and, as Schein et al. wrote in one of their papers, the real cause of unsatisfactory studies is that “clinical trials compare populations of patients but source control decisions must be made for the individual patients” [37].

Several alternative techniques have been proposed for temporary abdominal closure during open management [29 –34,39]. It remains unclear whether any of these approaches is superior. The ideal temporary abdominal wound closure should contain the abdominal viscera, protect the viscera from mechanical injury, prevent bowel desiccation, prevent adherence of the viscera to the closure materials, and the abdominal wall, minimize loss of abdominal domain, be applicable rapidly, be capable of multiple applications, and be inexpensive.

In our recent experience, March 2006–October 2007, vacuum-assisted wound management was used. The mean duration of open management was 22.7 days, but we evidenced a significant difference in relation to the timing of surgical control. When the abdomen was closed at a mean of 8.5 days, few complications and a definitive fascial closure rate of 100% were observed in this subgroup of patients. By contrast, 34.2 days was the mean time to abdominal closure in patients with delayed source control. Definitive primary fascia closure was performed in six of our nine patients (66%), and two patients had delayed wound closure. Closure was obtained for an elderly female with a spilt-thickness skin graft; a ventral hernia developed afterward. These results are similar to those of Barker et al. [7]; in particular, fascial closure was possible in their patients with a short period of open management. Our data are in contrast to those reported by Robledo et al. [36], in particular regarding the mortality rate. We agree that open treatment can be associated with high morbidity and mortality rates, but the presence of a severe abdominal infection with incomplete source control associated with abdominal hypertension is a condition that, in our opinion, requires this invasive surgical management.

Wittmann et al. proposed other procedures that facilitate both access to the peritoneal cavity and gradual advancement of the fascial edges [20]. In 1995, Brock et al. described a composite, sutureless, negative atmospheric pressure dressing as a temporary abdominal closure vacuum pack [38]. Used initially in trauma patients, this procedure was expanded thereafter to a variety of general surgical conditions. The negative abdominal pressure solved the problem of controlling the effluent from the open peritoneal cavity. Topical negative pressure is sutureless, and there is no damage to the abdominal wall tissue; in this way, when possible, primary closure is made with minimal tissue damage. Another particular characteristic of the vacuum pack is the cost; components are available readily and inexpensive, and the total cost of the dressing is less than $50 [21]. The method proposed by Argenta and Morykwas, which applies negative pressure to polyurethane foam, is expensive, and many authors point out this drawback.

We used the VAFC-KCI. In our opinion, the perforated polyethylene sheet, the deepest layer of the abdominal dressing and the most expensive part, should be useful in the early phases of abdominal infection when bowel separation and additional debridements are mandatory. In our experience, a mean of 2.2 ± 1.4 abdominal dressings was needed for each patient. Thereafter, a simple non-adherent gauze, placed underneath the polyurethane sponge, could replace the abdominal dressing in order to protect the viscera. Polyurethane sponge and negative pressure together assure the optimal environment for healing. The use of non-adherent gauze has, in our experience, substituted for the expensive abdominal dressing, reducing costs and maintaining all positive effects secondary to the association of continuous topical negative pressure and polyurethane sponge. Other strategies have been reported to reduce costs; for example, the abdominal dressing could be replaced with a commercially available thin isolation bag (Vi-Drape; Medical Concepts Development, Woodbury, MN) without any complications [39].

All patients with an open abdomen and severe sepsis should be managed in the ICU. In our experience, all nine patients had some degree of pulmonary dysfunction. Other patients needed hemodynamic assistance and monitoring. The cooperation between ICU specialists and surgeons is essential in these critical circumstances. The timing of re-exploration is based on patient stability and intra-abdominal pathology. The decision to continue with open abdominal management is made at the time of each re-operation and is based on clinical conditions and the CT findings concerning residual infection sources. All patients in this series underwent repeated dressings, and a mean of 2.2 postoperative CT examinations were performed. A mean of 14.3 re-explorations of the abdominal cavity were executed. Forty-six explorations were made, 38 in the operating room and eight in the ICU. Considering the severity of disease and the costs for the treatment of severe sepsis, we believe that resources for acquiring the abdominal dressing are a justifiable expense.

In our recent usual practice, we have not used any biosynthetic material. In particular, we have not used any mesh for definitive treatment. In the past, we used a polypropylene mesh or a temporary abdominal wound closure device (Ethizip, Ethicon, Somerville, NJ) for temporary closure of the abdomen. The mesh or zipper was sewed to abdominal fascial edges in order to prevent fascial retraction in 30 patients with multiple abdominal abscesses. At the end of the open treatment, the device used as temporary closure was removed. In patients treated in this way, we reported a bowel fistula incidence of 10% and fascia-to-fascia closure of 56% [34]. These two different experiences from the same authors suggest that any fascial substitute should be temporary in the presence of a complex open abdomen management.

Enteric fistulas are a difficult problem during open management. Care must be taken when handling the bowels, particularly at re-exploration, because the serosal surface becomes increasingly easy to damage. Fistula formation is more common in exposed bowel, and extreme caution is important during re-exploration or dressing change. The incidence of fistula formation in our experience was low, only one case. All surgeons in our institution, including the authors of the present paper, have experience in open abdominal management. Revisions were done by the senior surgeons, who have treated more than 100 patients with open methods [13 –15].

In conclusion, a high rate of fascial closure is an interesting result of this preliminary prospective study, in particular if it is considered that all our patients had severe infectious and no patient had a single abdominal dressing. Primary fascia-to-fascia closure was easier in patients with early source control. In other experiences with trauma patients or patients undergoing emergency repair of a ruptured abdominal aortic aneurysm, re-exploration was not necessary, and abdominal closure was easier. In other words, management of the abdominal wall in trauma and “clean” surgery patients is different from that in patients with an infected abdomen [40].

We believe that the combination of polyurethane sponge and negative pressure could be the preferred way to accelerate granulation, promote closure of the abdominal site, and prevent formation of large ventral hernias. The use of non-adherent gauze plus polyurethane sponge could replace the expensive abdominal dressing and maintain all the positive effects of continuous topical negative pressure. This way of temporary abdominal management is associated with a high rate of fascial closure and few local complications. In our short experience, the VAFC systems seems to be effective in patients with open abdomens.

Footnotes

Author Disclosure Statement

No conflicting financial interests exist.

Presented at the 21^st Annual Congress of the Surgical Infection Society–Europe, Antalya, Turkey, May 1–3, 2008.

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