A study to determine the rate of infection of wounds from abdominal operations across Nigeria

Not Applicable

• Conditions: Abdominal operations; Surgery

• Registration Number: ISRCTN14422305
• Lead Sponsor: Association of Surgeons of Nigeria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-25
• Last Update Posted: 12 August 2024
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

1.Patient able and willing to provide written informed consent (signature or a fingerprint) or assent from parent or guardian
2.All children and adult patients undergoing emergency or elective abdominal operations
3.Benign, malignant and trauma cases can all be included
4.Abdominal incision with an anticipated clean-contaminated, contaminated or dirty surgical wound
5.Anticipated abdominal incision of 3cm in children or 5cm or more in adults
6.Both open surgery and laparoscopic surgery can be included
7.All secondary, tertiary, public, and privately funded hospitals that perform abdominal surgeries will be eligible

Exclusion Criteria

1.Abdominal operations with clean surgical wound, such as simple hernia repair
2.Patients undergoing caesarean section will be excluded
3.Patients who are unable to complete follow-up at post-operative day 30
4.Patient already enrolled in another trial assessing surgical site infection

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical site infection (SSI) 30 days post operation, defined according to Centre for Disease Control criteria

Secondary Outcome Measures

Name	Time	Method
Measured using patient records:<br>1.Profile of organisms detected from wound swab<br>2.Patient-reported time taken to return to normal activities<br>3.Patient-reported time taken to return to work.<br>4..Mortality at day 30 after operation and its relationship to SSIs