Prophylactic Negative Pressure Dressings for Closed Laparotomy Wounds - A Randomised, Controlled, Open Label Trial

Phase 2

Completed

• Conditions: Infection
• Interventions: Device: Negative pressure dressing; Device: Standard wound dressing

• Registration Number: NCT02780453
• Lead Sponsor: University Hospital of Limerick

Brief Summary

Laparotomy wounds are associated with high rates of surgical site infections (SSI). The effect of prophylactic negative pressure dressing of closed incisional wounds on SSI rates is inconclusive.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-05-19
• Study First Posted: 2016-05-23
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-26
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Elective and emergency abdominal surgery

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative pressure dressing	Negative pressure dressing	Negative pressure dressing
Standard dressing	Standard wound dressing	Standard wound dressing

Primary Outcome Measures

Name	Time	Method
Surgical site infection rate	30 days

Trial Locations

Locations (1)

University Hospital Limerick; 🇮🇪 Limerick, Ireland