vacuum-assisted closure of laparostomy wounds: a critical review of the literature

ORIGINAL ARTICLE

Vacuum-assisted closure oflaparostomy wounds: acritical review of theliteraturePhilip Stevens

Stevens P. Vacuum-assisted closure of laparostomy wounds: a critical review of the literature. Int Wound J 2009;6:259–266

ABSTRACTVacuum-assisted closure (VAC) reduces the burden for carers of laparostomy wounds but evidence from randomisedtrials is lacking. This review analyses the evidence for the VAC® abdominal wound management system (KCI,San Antonio, TX) in the open abdomen. Three prospective studies provide level III evidence that VAC® allowsdelayed primary fascial closure in the majority of these wounds up to 21 days after occurrence, but not whereduration of VAC® was less than 9 days or if vacuum pack techniques were used in place of VAC®. Fistulaeoccurred in a minority of wounds complicated by multi-organ failure or sepsis and could not be attributed to VAC®

itself. Two retrospective analyses suggested VAC® may reduce re-operation rate and length of stay in complexwounds. Whilst randomised controlled trials remain the gold standard of evidence for effectiveness of health careinterventions, contemporaneous level III evidence supports the hypothesis that VAC® increases the rate of primaryfascial closure. Whilst enterocutaneous fistula formation is reported in the most complex of these wounds, there isno more evidence that these are consequential to as opposed to coincident with VAC® use.

Key words: Laparostomy • Open abdomen • Temporary abdominal closure • Topical negative pressure • Vacuum-assisted closure

INTRODUCTIONLaparostomy, or the open abdomen, has devel-oped over the last 20 years as a life-saving inter-vention in surgical emergencies for abdominalcompartment syndrome, wound dehiscence,trauma and intra-abdominal sepsis (1–6). Suchwounds are classified by severity as type II,III or IV (Table 1) (7). Invariably, the openabdomen imposes a significant burden onnursing staff caring for these critically illpatients.

Authors: P Stevens, MBBCh(Hons) MRCS(Royal College ofSurgeons of England), Department of General Surgery, NevillHall Hospital, Brecon Road, Abergavenny, NP7 7EGAddress for correspondence: P Stevens, MBBCh(Hons)MRCS(Royal College of Surgeons of England), Department ofGeneral Surgery, Nevill Hall Hospital, Brecon Road, Abergavenny,NP7 7EGE-mail: [email protected]

Consequent to the loss of abdominal wallintegrity, medical management is compli-cated by marked fluid shifts, loss of proteinand heat, and contamination with exogenousbacteria (8,9). Primary goals of wound man-agement include mechanical containment ofabdominal viscera, active removal of exudate,third space fluid loss estimation, infection con-trol and prevention of intestinal fistulae (8,10).The ideal dressing for temporary abdominalclosure (TAC) would achieve these primaryaims without trauma or adherence to underly-

Key Points

• laparostomy, or the openabdomen, has developed overthe last 20 years as a life-saving intervention in surgi-cal emergencies for abdom-inal compartment syndrome,wound dehiscence, trauma andintra-abdominal sepsis

• primary goals of wound man-agement include mechanicalcontainment of abdominal vis-cera, active removal of exu-date, third space fluid loss esti-mation, infection control andprevention of intestinal fistulae

ing bowel (7,11).Various materials have been used to dress

the open abdomen including intravenous fluidbags, Goretex, Bogota bags and sandwichedgauze dressings (12). Topical negative woundtherapy (TNWT) applies the principle of top-ical negative pressure (TNP), through the useof suction tubing and an occlusive dressing

© 2009 The Author. Journal Compilation © 2009 Blackwell Publishing Ltd and Medicalhelplines.com Inc • International Wound Journal • Vol 6 No 4 259

Vacuum-assisted closure of laparostomy wounds

Table 1 Classification of abdominal wounds (7)

Classification Wound type

I Superficial (skin only)II Deep (exposed bowel or omentum)III Complex (intra-abdominal sepsis)IV Complex (enterocutaneous fistula)A No prosthetic materialB Prosthetic material present

(the vacuum pack method), to divert contam-inated effluent away from the peritoneal cav-ity. However, simple vacuum pack techniquesdo not directly assist fascial closure or gran-ulation (13–15). The VAC®(Vacuum-AssistedClosure) Abdominal Dressing System (KCI,San Antonio, TX) (11) has the advantage ofstandardising equipment, making applicationand nursing care easier. It is also claimed toencourage wound closure through a processof reverse tissue expansion, thereby reducingthe need for planned ventral hernia forma-

Key Points

• simple vacuum pack tech-niques do not directly assistfascial closure or granulation

• the VAC® (Vacuum-AssistedClosure) Abdominal DressingSystem (KCI, San Antonio, TX)has the advantage of stan-dardising equipment, makingapplication and nursing careeasier

• it is also claimed to encour-age wound closure through aprocess of reverse tissue expan-sion, thereby reducing the needfor planned ventral hernia for-mation

• the aim of this review is to sys-tematically find and appraisecontemporaneous evidence forVAC of grade II or III abdom-inal wounds using the VAC®

Abdominal Dressing System• a systematic literature search

for primary research articleswas performed on EMBASE,OvidMEDLINE, AMED, Global-Health, British Nursing Index,PsycINFO, Health Manage-ment Information Consor-tium (HMIC), Meta-Press,the Cochrane Library, GoogleScholar, PubMed, Scopus, Webof Science, Bandolier, Zetocand the Centre for Reviewsand Dissemination; Medline In-process was interrogated toretrieve results from ongoingtrials and non indexed citations

tion (11,16).The role of VAC® in the management of type

IV wounds has so far only been reported in afew case series (17–21). We prefer the VAC® fortype II and III wounds, although opinion onthe evidence for this practice remains divided.Observational studies are susceptible to con-founding and bias (22) and industry sponsoredtrials are known to be more likely to concludein favour of their own product (23). Althougha number of systematic reviews of VAC®exist,these have not focussed on its application inTAC for the open abdomen (24–30). The aimof this review is to systematically find andappraise contemporaneous evidence for VACof grade II or III abdominal wounds using theVAC® Abdominal Dressing System.

LITERATURE REVIEW

Search strategyA systematic literature search for primaryresearch articles was performed on EMBASE,Ovid MEDLINE, AMED, Global Health, BritishNursing Index, PsycINFO, Health Manage-ment Information Consortium (HMIC), Meta-Press, the Cochrane Library, Google Scholar,PubMed, Scopus, Web of Science, Bandolier,Zetoc and the Centre for Reviews and Dissem-ination. Medline In-process was interrogatedto retrieve results from ongoing trials and nonindexed citations.

The search strategy used was (openabdomen) OR (laparostomy) OR (abdominalcompartment syndrome) AND (VAC dress-ing) OR (VAC) OR (TNP). Search terms wereused as medical subject headings (MeSH) andas keywords. Backward chaining was usedto identify studies not retrieved by databaseexploration. The last search was performed inJanuary 2009. No language restrictions wereimposed on these searches.

Inclusion and exclusion criteriaInclusion criteria were primary research arti-cles on VAC® dressings used in type II or IIIabdominal wounds. Studies of vacuum packand non vacuum dressings were excluded.Articles primarily focussing on enterocuta-neous fistulae (type IV wounds) were alsoexcluded. Editorials, letters, duplicated refer-ences and review articles (except systematicreviews and meta-analyses) were excluded.Individual case reports were excluded becauseof intrinsic selection bias and lack of general-isation but case series were included. Elevenarticles were identified by these search criteria.

Method of critical appraisalCritical appraisal of evidence was performedaccording to Crombie’s model (31). Table 2describes the classification of levels of evidenceused (32).

CRITICAL APPRAISAL OF THEEVIDENCE

Prospective studiesMiller et al. (2004) (33) reported the use ofVAC® dressings in a prospective, single cen-tre comparative study of 53, mostly young,

Table 2 Levels of evidence (32)

Level of evidence Requirement

Ia Meta-analysis of randomised controlledtrials

Ib At least one randomised controlled trialIIa At least one well-designed controlled

trial without randomisationIIb At least one other type of well-designed,

quasi-experimental studyIII Well-designed non experimental

descriptive studies such ascomparative studies, correlationstudies, case-control studies

IV Expert opinions and/or clinical experienceof respected authorities

260 © 2009 The Author. Journal Compilation © 2009 Blackwell Publishing Ltd and Medicalhelplines.com Inc


abdominal trauma patients with type IIAwounds. They concluded the rate of success-ful primary fascial closure (88%) and timedelay possible before attempt of fascial clo-sure (up to 21 days) were both significantlyimproved with VAC® dressings comparedagainst historic controls (level III evidence). Noenterocutaneous fistulae were reported withVAC® and no conflicting interests of authorswere evident. However, systematic errors wereevident despite thorough reporting of method-ology.

The study design prevented blinding ofsubjects or observers. Although injury severityscores were considered, no classification ofwound severity was used to standardisecomparisons raising doubt over inter- andintra-rated reliability of outcome data. Relianceon historic controls prevented randomisationor allocation concealment of participants.Selection of historic data was also dependenton authors’ search criteria, which was notspecified. Temporal factors may have causedoutcome differences because of unreportedchanges in other treatment modalities.

The validity of authors’ inference thatimprovement in VAC® technique was account-able for the increased fascial closure rate isquestionable. An earlier study by the sameauthors (34) found closure rates no better thanhistoric controls (69% versus a quoted rate of50–70% in reviewed literature). Miller et al. (33)may be subject to a type 1 error (inappropri-ate rejection of the null hypothesis) because nopower calculation was performed pre or posthoc. Hence results may represent a chancefinding due to the small sample size, especiallyin view of results differing with their earlierstudy (34).

Miller et al. (33) report mean rather thanmedian measures of central tendency, despitedata suggestive of a positive skew. Forexample, duration of follow-up is quoted asa mean of 185 days but the range of 144–708suggests a positively skewed distribution.Thus, average follow-up may seem longerthan it would have been had median beenquoted here. The failure to censor follow-upat a specified date also makes evaluation oflate hernia occurrence impossible (quoted asaffecting only one patient) as no standardiseddenominator can be used to account for thoselost to follow-up.

In a prospective observational cohort study,Perez et al. (35) reported results up to 1 yearfollowing laparostomy for abdominal sepsisor compartment syndrome (mostly type IIIAwounds) in 37 patients (level III evidence).Trauma cases were excluded, severely limitingthe available sample population and limitinggeneralisation to a highly specific patientgroup. This also reflected the older samplepopulation compared with Miller et al. (33).Greater methodological rigor was evidentthrough both choice of statistical analysesand inclusion of a control group (level IIaevidence), compared with Miller et al. (33);although the choice of elective patients meantthis control was not valid for considerationof fascial closure rates. Instead fascial closurewas compared with historical cohorts (levelIII evidence). Unlike the earlier paper, Perezet al. (35) applied VAC® to all cases, regardlessof the presence of oedematous bowel. Despitethis, only one fistula was reported.

Owing to longer duration of follow-up, Perez et al. (35) reported greater overallmortality than previous studies with only35% of patients alive at 3 months, despitefavourable in-hospital mortality. However,survivors compared favourably to elective con-trols in psychometric assessment using themedical outcomes study 36-item short-formhealth survey, validated for use in inten-sive care patients (36,37). This was despitepoorer wound appearance, as measured byboth visual analogue scales and the Vancouverscar scale (38,39). Physical and mental statuswas comparable to controls from 3 months on.

Allocation concealment was only attemptedat long-term follow-up by use of independentassessors, but not for short-term results andtherefore bias may exist in reporting of earlycomplication rates. Duration of the openabdomen did not correlate with the choice offascial closure technique and although closurewas achieved in 70% of cases, only half of thesewere achieved by direct suture, others requiredcomposite mesh insertion.

Randomised trialsA randomised trial comparing different typesof TAC was reported by Bee et al. (40). Fifty-one patients were randomised to receivevacuum packing or VAC® dressings orpolyglactin-910 mesh temporary abdominalrepair, following abdominal trauma or general

© 2009 The Author. Journal Compilation © 2009 Blackwell Publishing Ltd and Medicalhelplines.com Inc 261


surgical emergencies (type IIA and IIIAwounds). Use of a prospective study designand randomisation greatly reduced potentialfor bias, providing level Ib evidence. How-ever, strict selection criteria meant that only21% of open abdominal procedures were ran-domised, leaving a small sample population of51 patients and therefore poor statistical powerto refute the null hypothesis (i.e. likelihood ofa type 2 error). This also limited scope to gen-eralise to other populations. The authors wereunable to demonstrate significant differencesin primary fascial repair rates [both groupslower than Miller et al. (33)], fistula and abscessformation, or mortality [which was higher thanMiller et al. (33) despite similar injury severityscores].

Several other important methodological dif-ferences exist between Bee et al. (40) and Milleret al. (33). Bee et al. (40) considered vacuumpack and VAC techniques as equivalent ratherthan different but related technologies andthe actual number of VAC® applications waslow (only 5 of the 31 negative pressure dress-ings used). Analysis was not on an intentionto treat basis as seven deaths were excludedafter randomisation, demonstrating lack of sta-tistical rigor. The design of this randomisedtrial involved application of negative pressuredressings for a total of 9 days therefore stop-ping vacuum therapy at the very point Milleret al. (33) advocated its benefit would start toincrease fascial closure rates. As with Milleret al. (33), Bee et al. (40) relied on parametricanalyses despite probable non normal distri-bution of data.

The authors acknowledged that randomi-sation by sealed envelopes, whilst concealingallocation, may have led to a disparity betweencomparison groups over an electronically gen-erated randomised allocation. Also, a greaterproportion of their randomised subjects expe-rienced penetrating abdominal trauma thancases in Miller et al. (33). Although injuryseverity scores were comparable, underlyingpathology was therefore very different.

Nevertheless, Bee et al. (40) recruited a con-temporary comparison group matched for age,gender and injury severity score rather thanrelying on historic controls. They also consid-ered absolute cost of each treatment modalityalthough fell short of comprehensive analysisof health economic effects because of inad-equate long-term follow-up to compare the

eventual health burden from the consequentmorbidity of each approach.

Key points of prospective evidenceVAC® appears to allow delayed primary fas-cial closure in the majority of open abdominalwounds, up to 21 days after type IIA (33)and IIIA (35) wounds (level III evidence). Thiswas not seen with duration of treatment forless than 9 days or where vacuum pack tech-niques were used in place of VAC® (40) (levelIb evidence). Fistulae were reported only inthe minority of type IIIA wounds (35) and inno type IIA wounds (33) and could not becausally attributed to VAC® use. VAC® alsofacilitated favourable psychometric outcomesin those surviving for 3 months or more (levelIIa evidence) (35).

Retrospective studiesOlejnik et al. (41) reviewed their experiencewith laparostomy for confirmed severe intra-abdominal sepsis (mostly cases of infected pan-creatic necrosis, grade IIIA wounds) over an8-year period. They divided subjects into twochronologically distinct cohorts (level III evi-dence), the earliest of which preceded VAC®

use whereas the later group received VAC(although at only half the pressure appliedby the KCI VAC® system, which may reflectconcern to avoid fistula formation). Some ofthe obvious problems of a retrospective studydesign arose from lack of control of confound-ing variables and, in this study, highly selectiveinclusion criteria which limited sample size. Aswith Perez et al. (35), highly selective cohortshave limited scope for generalisation; thisstudy primarily described VAC® in cases ofinfected pancreatic necrosis. Again, the smallsample size indicates a low power with whichto refute the null hypothesis and thereby risksa type 2 error.

Olejnik et al. (41) concluded mortality, re-operation rate and hospital stay were reducedby use of VAC®, although only the lattertwo confirmed statistical significance. Twofistulae were reported but both were allegedto resolve with continued VAC therapy.Although treatment protocol was reportedexplicitly in this paper, the duration of follow-up was unclear and no consideration was madeof fascial closure rate or long-term outcome,making comparison with other studies of VACuse limited.



Arigon et al. (42) compared 18 laparos-tomies managed with VAC® augmented by apolyethylene film covering abdominal viscera,with four standard VAC® procedures (levelIII evidence). All causes of laparostomy wereincluded allowing generalisation to trauma orsepsis related patient groups (type IIA and IIIAwounds). Patient demographics were compa-rable to previous studies. Strength for thisstudy came from authors following patientsfor 29 months after surgery, although samplesize, as with other studies, was small partic-ularly in the comparison group (four cases).Perhaps in view of the lack of power, statis-tical comparison of the two groups was notperformed; results therefore became purelydescriptive.

Hospital mortality in the combined VAC®

and polyethylene group was 17% with atleast one anastomotic leak, although causesof death were felt attributable to initial injuryrather than VAC®, a conclusion which mustbe interpreted with caution in retrospectivedata. Delayed primary closure was achieved in40% with polyethylene, comparable with Beeet al. (40), but in none of the small cohort ofstandard VAC®. Early complications reportedincluded an intra-abdominal abscess, chronicwound suppuration, two intra-abdominalbleeds, ischaemic colitis requiring resection butno fistulae or evisceration. Long-term follow-up identified four ventral hernias in thosenot receiving primary closure, emphasisingthe importance of primary fascial closure.Authors estimated the cost of VAC therapyto be approximately ¤2000 per case butagain fell short of a full health economicevaluation.

Key points of retrospective evidenceVAC® may reduce re-operation rates andlength of stay in type IIIA wounds (level

III evidence) (41), although not all centresachieved such high fascial closure rates asMiller et al. (33) and Perez et al. (35) and failureto close fascia primarily remains complicatedby ventral hernia formation on later follow-up(level III evidence) (42).

CASE SERIESCase series offer a body of observational datawhich provide credibility for a historical cohortthat may be compared against future trials (43).However, the lack of a comparison group pre-vents objective evaluation of effect from thevariable of interest and authors’ inferences aretherefore biased by pre-established expecta-tions. Identified case series are summarisedin Table 3 as level IV evidence (clinical expe-rience of respected authorities) only to addweight to conclusions of those from the doc-umented comparative studies (44–49). A few,however, require specific attention to method-ological errors.

Rao et al. (47) cited a high incidence offistulae in non trauma cases, although fiveof these cases had established multi-organfailure before VAC® therapy. Hence, withno comparison group, fistulation cannot beattributed to the effect of VAC anymorethan as a consequence of poor anastomotichealing because of severe systemic illness orunderlying pathology. von Ruden et al. (49)reported a modification of the VAC® system tocombine advantages of the Bogota bag whereevisceration could not be reduced. Althoughpotentially a useful precursor to developmentof prospective trials, the analysis focussed onchanges in intracranial pressure for subjectswith comorbid head injuries with little regardfor abdominal complications and thus addslittle to the other case series’ data. Withthese exceptions as noted, the case seriesappear consistent with the expected frequency

Table 3 Summary of case series

Fascial closureWound Duration of VAC Hospital

Study Year Cases type days (range) mortality Primary Secondary Mesh Fistulae

Labler et al. (44) 2005 18 – trauma IIA 2.5 (1–7) 28% 93% 8% – –Heller et al. (45) 2006 9 – dehiscence II/IIIA 5 (2–21) – 69% 31% 43% 22%Cothren et al. (46) 2006 14 – mixed II/IIIA 7.5 (4–16) – 100% 0% 0% –Rao et al. (47) 2007 29 – sepsis IIIA 26 (2–68) 34% – – – 20%Durmishi et al. (48) 2007 48 – sepsis IIIA –(20–30) – 75% 6% 19% 0%von Ruden et al. (49) 2008 5 – trauma IIA 22 (–) – 100% – – –



of primary fascial closure and fistula ratepredicted by the comparative reports (Table 3).Key Points

• seeing first hand the effectof VAC® therapy on complexabdominal wounds in one’sown practice on a regular basis,it is hard to believe such adevice is anything other thanefficacious

• however, there remains apaucity of high quality, rigorousclinical trials to support thisnotion, as seen from theidentified literature

• data for the occurrence of ente-rocutaneous fistulae resultingfrom, as opposed to coincid-ing with VAC® dressing usein the open abdomen needsclarification

• existing level III evidence atleast supports the hypothesisthat VAC® therapy increasesthe likelihood of successfuldelayed primary fascial closureand thereby may reduce thelate presentation of ventralhernias

• in view of the cost of VAC®

therapy compared with alter-natives, there is also a need forbroader health economic stud-ies and National Institute ofHealth and Clinical Excellence(NIHCE) guidance to clarify thefuture role of VAC® dressings

• contemporaneous level III evi-dence supports the hypothesisthat VAC® therapy increasesthe rate of successful pri-mary fascial closure in type IIAand IIIA abdominal wounds;although several methodolog-ical weaknesses were evidentin the small trials published

• the open abdomen remainsa complex clinical problemfor critically ill patients withinsurgical critical care units, thedressing of which representsonly one of a multitude ofprognostic factors

• cumulative observational evi-dence indicates withdrawal ofthis technology from our prac-tice would be inadvisable with-out clear evidence against itsuse

DISCUSSIONSeeing first hand the effect of VAC® therapyon complex abdominal wounds in one’sown practice on a regular basis, it is hardto believe such a device is anything otherthan efficacious. However, there remains apaucity of high quality, rigorous clinical trialsto support this notion, as seen from theidentified literature. Data for the occurrenceof enterocutaneous fistulae resulting from, asopposed to coinciding with VAC® dressinguse in the open abdomen needs clarification.Existing level III evidence at least supportsthe hypothesis that VAC® therapy increasesthe likelihood of successful delayed primaryfascial closure and thereby may reduce the latepresentation of ventral hernias.

Whilst randomised controlled trials remainthe gold standard of evidence for effectivenessof health care interventions (30), the complex-ity of a problem such as laparostomy may pre-vent homogenisation of sample populations,control of confounding variables, true blindingor allocation concealment (50). Ethical practicemay conflict with academic purity in the faceof expedient progression of technology, espe-cially when data from observational studiescompares favourably with the natural historyof an illness. This may be seen by analogy in thelack of randomised trials of appendicectomyor, as Smith and Pell (51) note, the evidencebase for the efficacy of parachute use. Never-theless, there remains scope for developmentof future multi-centre trials for comparison ofdifferent techniques of TAC. In view of the costof VAC® therapy compared with alternatives,there is also a need for broader health eco-nomic studies and National Institute of Healthand Clinical Excellence (NIHCE) guidance toclarify the future role of VAC® dressings.

In conclusion, contemporaneous level IIIevidence supports the hypothesis that VAC®

therapy increases the rate of successful pri-mary fascial closure in type IIA and IIIAabdominal wounds (33,35,41); although sev-eral methodological weaknesses were evidentin the small trials published. Cost benefitof this evolving treatment modality remainsunclear and, whilst enterocutaneous fistula for-mation is reported in the most complex ofthese wounds (type IIIA), there is no more

evidence that these are consequential to asopposed to coincident with VAC® use (40,42).Comparison with cheaper alternative meth-ods of TAC now needs evaluation in large,multi-centre, randomised comparison trials.The open abdomen remains a complex clin-ical problem for critically ill patients withinsurgical critical care units, the dressing ofwhich represents only one of a multitude ofprognostic factors. Cumulative observationalevidence (44–49) indicates withdrawal of thistechnology from our practice would be inad-visable without clear evidence against its use.

ACKNOWLEDGEMENTSI would like to thank S Holloway of CardiffUniversity for the encouragement to submitthis article for publication.

CONFLICT OF INTERESTDECLARATIONThere were no conflicts of interest on thepart of the author of this review and themanufacturers of the VAC®abdominal wounddressing system.

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vacuum-assisted closure of laparostomy wounds: a critical review of the literature

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