The Effect of Timing of Removal of Wound Dressing on Surgical Site Infection Rate After Cesarean Delivery

Not Applicable

Completed

• Conditions: Surgical Site Infection

• Registration Number: NCT02902419
• Lead Sponsor: Albany Medical College

Brief Summary

A randomized controlled trial measuring surgical site infection rate as a function of timing of wound dressing removal.

Detailed Description

A randomized controlled trial with a sample size of 602 patients to study the effect of timing of wound dressing removal on the surgical site infection rate. 300 patients were randomized to a group that had the wound dressing removed between 12-30 hours postoperatively. 302 patients were randomized to a group that had the wound dressing removal between 30-48 hours postoperatively. Statistical analyses were performed to determine if the timing of dressing removal had statistical significance on the surgical site infection rate, the primary outcome.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-03
• Study Completion: 2012-05
• Status Verified: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-14
• Last Update Submitted: 2016-09-14
• Study First Posted: 2016-09-15
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 602

Inclusion Criteria

• patients ages 18-50 years;
• medically competent (no proxies or prisoners); and
• multifetal and singleton gestations from 23 0/7 weeks to 42 0/7 weeks gestational age.

Exclusion Criteria

• Inability to obtain informed consent;
• fetal death;
• immunocompromised patients; patients taking immuno-suppressants; history of documented surgical site infection; or patients requiring reoperation within the 6 week postoperative period for indications other than wound dehiscence/debridement/infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical Site infection Rate	6 weeks postoperatively	Cellulitis, purulent drainage, abscess or wound requiring drainage, debridement, and antibiotics associated with a clinical diagnosis of infection. Any disruption of fascia or subcutaneous skin.

Trial Locations

Locations (2)

St. Peter's Hospital; 🇺🇸 Albany, New York, United States

Bellevue Women's Center; 🇺🇸 Niskayuna, New York, United States