Clinical trial NCT02902419: The Effect of Timing of Removal of Wound Dressing on Surgical Site Infection Rate After Cesarean Delivery
Official title: The Effect of Timing of Removal of Wound Dressing on Surgical Site Infection Rate After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 602
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical Site infection Rate
timeFrame: 6 weeks postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: St. Peter's Hospital
state: New York
city: Niskayuna
country: United States
facility: Bellevue Women's Center
state: New York
Study officials:
affiliation: Albany Medical College
name: Peter R Cole, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albany Medical College
name: Kevin C Kiley, MD
role: STUDY_CHAIR
References:
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