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

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Albany Medical College

Status

Completed

Conditions

Surgical Site Infection

Treatments

Other: Wound dressing removal.

Study type

Interventional

Funder types

Other

Identifiers

NCT02902419
AlbanyMC2984

Details and patient eligibility

About

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

Full 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.

Enrollment

602 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

602 participants in 2 patient groups

1
Active Comparator group
Description:
Wound dressing removal was performed between 12-30 hours postoperatively.
Treatment:
Other: Wound dressing removal.
2
Active Comparator group
Description:
Wound dressing removal was performed between 30-48 hours postoperatively.
Treatment:
Other: Wound dressing removal.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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