Vergelijk wonduitkomsten na stoma-omkering tussen NPWT en secundaire intentie genezing
Negatieve druk wondtherapie versus secundaire intentie genezing bij stoma-omkering: Een gerandomiseerde gecontroleerde studie die chirurgische plaatsinfectie en wondresultaten evalueert
This was a single-center, parallel-group randomized controlled trial conducted in 2025 at the General Surgery Ward of the Sindh Institute of Urology and Transplantation (SIUT), Karachi. The study compared negative pressure wound therapy (NPWT) with healing by secondary intention (SIH) for patients undergoing stoma reversal surgery.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Study Design and Participants A total of 92 adult patients (aged ≥18 years) scheduled for stoma reversal were assessed for eligibility. Of these, 72 patients who met the inclusion criteria and provided informed consent were enrolled and randomized in a 1:1 ratio into NPWT (intervention) and SIH (control) groups (n=36 each). Eligibility criteria included patients undergoing elective or emergency stoma reversal with conventional layered closure of the muscular layer and skin management by either NPWT or SIH. Exclusion criteria included use of skin closure techniques other than suture, prolonged antibiotic use before surgery, or need for reoperation for causes other than surgical site infection (SSI).
Randomization and Allocation Random allocation was performed using simple random sampling by lot draw. A list of consecutive serial numbers with equal halves of even and odd numbers was utilized. Each number was printed separately on slips of paper and folded to conceal. A slip was drawn for each patients allocation. Patients who drew odd-numbered lots were assigned to the treatment group (NPWT), and those with even-numbered lots to the control group (SIH). This approach ensured unbiased allocation while maintaining transparency.
Interventions In both groups, stoma reversal was performed following standard operative protocols with fascial layer closure using absorbable sutures. In the NPWT group, after the procedure, the skin was left open and covered with four sterile gauze layers. An 18 Fr Nelaton catheter was placed directly over the wound and sealed with transparent, waterproof adhesive to create a vacuum. Continuous negative pressure was applied at 15 mmHg. Dressings were evaluated for SSI on postoperative days 2 and 4 using the ASEPSIS score; if no infection was present, the NPWT dressing was reapplied. On postoperative day 6, a final wound assessment was conducted, and further management was carried out as per departmental protocol.
In the SIH group, the wound was left open and dressed using four layers of sterile gauze and a transparent adhesive dressing. Similar to the NPWT group, dressing changes and assessments using the ASEPSIS score were performed on postoperative days 2, 4, and 6. If an infection was identified, standard management protocols were followed.
All patients received prophylactic antibiotics with piperacillin-tazobactam (4.5 g) administered 30 minutes before incision and three postoperative doses of the same antibiotic.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Sindh
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Karachi, Sindh, Pakistan, 74200
- Sindh Institute of Urology and Transplantation
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
All patients aged between 18-80 years undergoing stoma reversal surgery were included, following their formal consent for inclusion in the study protocol.
Exclusion Criteria:
- Patients with history of prolonged antibiotic use prior to stoma reversal surgery (>1months).
- Patients with prior skin condition that required medical treatment (for instance, Plaque Psoriasis).
- Patient with prior history of wound-related complication (like keloids or hypertrophic scars).
Furthermore, after allocation, the patients with the following protocol violations were also excluded:
- Patients who had undergone any other forms of wound closure after stoma reversal, that deviated from the study protocol.
- Patients who were re-operated during the hospital stay for any other reason than surgical site infection.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Negative pressure wound therapy
In the NPWT (negative-pressure wound therapy) group, after the procedure, the skin was left open and covered with four sterile gauze layers. An 18 Fr Nelaton catheter was placed directly over the wound and sealed with transparent, waterproof adhesive to create a vacuum. Continuous negative pressure was applied at 15 mmHg. Dressings were evaluated for Surgical site infection on postoperative days 2 and 4 using the ASEPSIS score; if no infection was present, a NPWT dressing was reapplied. On postoperative day 6, a final wound assessment was conducted, and further management was carried out as per departmental protocol. |
In the NPWT (negative pressure wound therapy) group, after the procedure, the skin was left open and covered with four sterile gauze layers. An 18 Fr Nelaton catheter was placed directly over the wound and sealed with transparent, waterproof adhesive to create a vacuum. Continuous negative pressure was applied at 15 mmHg. Dressings were evaluated for SSI on postoperative days 2 and 4 using the ASEPSIS score; if no infection was present, NPWT dressing was reapplied. On postoperative day 6, final wound assessment was conducted and further management was carried out as per departmental protocol. |
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Geen tussenkomst: secondary intention healing
In the SIH (secondary intention healing) group, the wound was left open and dressed using four layers of sterile gauze and a transparent adhesive dressing. Similar to the NPWT group, dressing changes and assessments using the ASEPSIS score were performed on postoperative days 2, 4, and 6. If an infection was identified, standard management protocols were followed. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Highest Postoperative Asepsis Score for SSI assessment
Tijdsspanne: Post-operative day (POD) 2, 4 and 6 (ASEPSIS score recorded)
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The primary outcome was the occurrence and severity of surgical site infection, assessed using the ASEPSIS scoring system (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay duration as an inpatient) on postoperative days 2, 4, and 6. The highest ASEPSIS score recorded across these time points was used for between-group comparison. The score may vary between. 0-70 with higher score representing worse outcome. |
Post-operative day (POD) 2, 4 and 6 (ASEPSIS score recorded)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Scar Cosmesis Assessment and Rating (SCAR) score on postoperative day 30
Tijdsspanne: On Postoperative day 30 wound cosmesis were assessed using scar scale
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All patient's operative wounds were assessed for cosmesis on postoperative day 30. This was performed utilizing the Scar Cosmesis Assessment and Rating (SCAR) scale for objective assessment. Scores range from 0 (best possible scar) to 15 (worst possible scar). |
On Postoperative day 30 wound cosmesis were assessed using scar scale
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Length of Stay
Tijdsspanne: 6-12 days. Following completion of study observations on postoperative day 6, patient may be discharged on meeting the discharge criteria. Expected between 6-12 days.
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Duration of stay assessed as: number of days of hospital stay after the index procedure till the patient discharged from hospital was recorded. |
6-12 days. Following completion of study observations on postoperative day 6, patient may be discharged on meeting the discharge criteria. Expected between 6-12 days.
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- SIUT-ERC-2025/A-275
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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