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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02902419
Enrollment
602
Registered
2016-09-15
Start date
2011-08-31
Completion date
2012-05-31
Last updated
2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Site Infection

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.

Interventions

OTHERWound dressing removal.

Sponsors

Albany Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Surgical Site infection Rate6 weeks postoperativelyCellulitis, purulent drainage, abscess or wound requiring drainage, debridement, and antibiotics associated with a clinical diagnosis of infection. Any disruption of fascia or subcutaneous skin.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026