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A clinical trial to assess whether Negative Pressure Wound Therapy is better than Conventional Wound management in post operative abdominal wounds.

Hospital based Interventional Study to compare Negative Pressure wound Therapy and Conventional Wound Therapy in Open Post-Operative Abdominal Wounds. - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/08/071904
Enrollment
75
Registered
2024-08-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: T814- Infection following a procedure

Interventions

Intervention1: Negative Pressure Wound Therapy: Continuous Mode of application, 125 mmHg suction pressure, changed every 5 days for 2 such applications, total duration of treatment 10 days. Control In

Sponsors

Debaraj Shome Purkayastha
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participant/Authorised Representative is willing and able to provide written informed consent. 2.Diagnosis of post-surgical subcutaneous abdominal wound healing impairment, i.e. with intact fascia. 3.Minimum wound size eligible for the application of the intervention, i.e. where NPWT is feasible (fixed at 10 sq. cm for this trial.)

Exclusion criteria

Exclusion criteria: 1.Age less than 18years. 2.A patient unable or unwilling to sign the Informed Consent Form, or to have their legally authorised representative act as a surrogate. 3.A patient unable or unwilling to comply with the protocol and study-related requirements. 4.Presence of Fascial defect of abdomen. 5.Necrotic tissue with eschar present. 6.Enteric or other Fistulae if present, or discharge containing Enteric content. 7.Possibility of Malignancy in wound.

Design outcomes

Primary

MeasureTime frame
Gross and Percentage Area Reduction of wound.Timepoint: Gross and Percentage Area Reduction of wound at Day 10 after 2 cycles of therapy.

Secondary

MeasureTime frame
Quality of Life assessment using Visual Analog ScaleTimepoint: At Day 10;Adverse eventsTimepoint: At every Dressing Change

Countries

India

Contacts

Public ContactDEBARAJ SHOME PURKAYASTHA

IPGMER and SSKM Hospital

gautamdas_dr@yahoo.co.in9830580728

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026