Reduction Of Surgical Site Infection using a Novel Interventio

Completed

• Conditions: Wound infection; Injury, Occupational Diseases, Poisoning; Complications of procedures, not elsewhere classified

• Registration Number: ISRCTN40402832
• Lead Sponsor: niversity Hospitals Birmingham NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 769

Inclusion Criteria

All adults (greater than 18 years of age, either sex) undergoing laparotomy via a midline incision (for any surgical indication), including both elective and emergency operations.

Exclusion Criteria

1. Patients less than 18 years of age, or unable to give informed consent
2. Laparoscopic-assisted cases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of post-operative wound infection, assessed at 7 and 30 days

Secondary Outcome Measures

Name	Time	Method
Assessed at 30 days:<br>1. Health related quality of life<br>2. Length of hospital stay<br>3. Cost effectiveness<br>4. The effect on the efficacy of a wound edge protection device in reducing wound infection of:<br>4.1. Degee of abdominal contamination<br>4.2. Comorbidity<br>4.3. Duration of surgery<br>4.4. Grade of surgeon closing the wound