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Comparison of wounds in stoma closure patients, conventional gauze dressing vs negative pressure wound therapy

Comparison between Negative Pressure Wound Therapy and Conventional Dressing on Stoma Closure Skin Wounds : A Randomized Controlled Trial (VACOMA Trial) - VACOMA

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112681
Enrollment
90
Registered
2026-06-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K639- Disease of intestine, unspecified

Interventions

Intervention1: Negative pressure wound dressing: Negative pressure wound dressing will be applied over the stoma reversal wound on post operative day 0 of surgery. It will be removed on day 3. The ASE

Sponsors

All India Institute of Medical Sciences, Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 or more at the time of consent Patient scheduled for stoma reversal Patient with ability and willingness to provide written informed consent and follow-up for atleast 3 months

Exclusion criteria

Exclusion criteria: Patients with refusal or inability to provide written informed consent Patient with known allergy or sensitivity to any NPWT dressing components

Design outcomes

Primary

MeasureTime frame
To compare proportion of patients achieving good wound status at POD3 and 10 between NPWT and conventional dressingTimepoint: Assessed on POD 3 and 10

Secondary

MeasureTime frame
Compare pain experienced on POD3 and 10 between NPWT and conventional dressingTimepoint: Assessed on POD 3 and 10;Compare incidence of SSI on day 30Timepoint: Assessed on day 30;Cost analysis between NPWT and conventional dressing on POD 10Timepoint: Assessed on POD 10;To compare cosmetic outcome of the wound after 3 monthsTimepoint: Assessed after 3 months

Countries

India

Contacts

Public ContactDr S Manwar Ali

AIIMS Bhubaneswar

akhilsundar07@gmail.com6282512760

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026