Vacuum-Assisted Closure Versus Graduated Primary Skin Closure for Postoperative Burst Abdomen
Vacuum-Assisted Closure Versus Graduated Primary Skin Closure for the Management of Postoperative Burst Abdomen: A Randomized Controlled Trial
Burst abdomen, or complete abdominal wound dehiscence, is a severe postoperative complication characterized by the separation of the musculo-aponeurotic layer of the abdominal wall. It leads to extended hospital stays, high treatment costs, and an increased risk of long-term incisional hernia. While negative pressure wound therapy using vacuum-assisted closure (VAC) is widely utilized, graduated (staged) primary skin closure remains a common, accessible bedside alternative. Direct randomized comparative evidence evaluating these two approaches for established burst abdomen is limited.
The main objective of this study is to compare the clinical effectiveness and safety of vacuum-assisted closure (VAC) versus graduated primary skin closure in the management of postoperative burst abdomen.
Participants will be randomly assigned (1:1) to one of two groups:
- VAC Group: Patients will receive continuous negative pressure wound therapy (-75 to -125 mmHg) applied via a specialized polyurethane foam and adhesive dressing, with changes performed every 48 to 72 hours until sufficient granulation tissue forms for definitive closure.
- Graduated Closure Group: Patients will undergo progressive re-approximation of the wound edges using full-thickness retention sutures placed under local anesthesia and tightened incrementally every 48 to 72 hours until complete closure is achieved.
The primary outcome of the study is the time to achieve complete fascial and cutaneous wound closure. Secondary outcomes include total length of hospital stay, incidence of surgical site infections, pain scores during procedures, wound recurrence, and incisional hernia formation during follow-up.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Adult patients aged 18 years or older of either sex
- Clinically confirmed complete (full-thickness) postoperative burst abdomen following a midline or paramedian laparotomy
- Medically fit to tolerate bedside wound management/re-intervention (hemodynamically stable, not requiring vasopressor support)
- Patient or legal guardian willing and able to provide written informed consent
Exclusion Criteria:
- Planned or pre-existing open abdomen (laparostomy) at the index operation
- Presence of enterocutaneous or enteroatmospheric fistula at the wound site
- Uncontrolled intra-abdominal sepsis or ongoing hemodynamic instability precluding safe wound management
- Known hypersensitivity or allergy to polyurethane foam or adhesive drape materials used in VAC systems
- Active malignancy with peritoneal carcinomatosis where wound closure is not a treatment priority
- Pregnancy
- Refusal to participate or to be randomized
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Vacuum-Assisted Closure (VAC)
Participants in this arm receive negative pressure wound therapy (NPWT) using an open-cell polyurethane foam dressing, fenestrated adhesive drape, and continuous sub-atmospheric pressure standardized between -75 and -125 mmHg.
A non-adherent protective layer is interposed over exposed bowel loops.
Dressing changes and wound assessments are performed under aseptic technique every 48 to 72 hours until sufficient granulation tissue forms to permit secondary suturing or delayed primary closure.
|
Under aseptic technique, non-viable tissue is debrided and the wound irrigated with normal saline.
An open-cell polyurethane foam is trimmed to fit the wound cavity (with a non-adherent protective layer over exposed bowel), sealed with an adhesive drape, and connected to continuous sub-atmospheric pressure (-75 to -125 mmHg).
Dressing changes and assessments are conducted every 48 to 72 hours until sufficient granulation tissue permits definitive closure.
|
|
Aktiv komparator: Graduated Primary Skin Closure
Participants in this arm undergo bedside staged/graduated primary wound closure using full-thickness interrupted monofilament retention sutures with bolsters/bridges across the abdominal wall under local anesthesia.
Sutures are progressively approximated and tightened in sequential sessions every 48 to 72 hours (mirroring the dressing change interval) to avoid tension-related tissue ischemia until complete fascial and skin apposition is achieved.
|
Full-thickness interrupted retention monofilament sutures with protective bolsters/bridges are placed across the abdominal wall under local anesthesia at the bedside.
Sutures are progressively tightened and approximated in sequential sessions every 48 to 72 hours to minimize tissue ischemia and tension until complete fascial and cutaneous apposition is achieved.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to Complete Wound Closure
Tidsramme: 30 days
|
Measured as the number of days elapsed from the date of randomization until complete fascial and skin apposition of the abdominal wound is achieved, verified by clinical examination.
|
30 days
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VAC vs Graduated Burst Closure
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