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Prospective Study on Cesarean Wound Outcomes

NCT01697748 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2019-11-14

Study results available
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Summary

This study will investigate whether the placement of silver impregnated dressings beginning in the OR will improve wound healing in patients undergoing cesarean delivery compared to traditional Telfa pads. This study will also explore the presumed improvement in scar integrity when silver impregnated dressings are used compared to the Telfa pads.

The study will compare the percentage of patients who develop a surgical site infection after application of silver impregnated dressings versus standard Telfa dressings. Investigators will also assess the cosmetic appearance and pain of the cesarean section scar at the patient's one week and 6 week post-operative visits.

Conditions

  • Surgical Site Infection
  • Cosmetic Appearance of Cesarean Scar
  • Post Operative Pain

Interventions

DEVICE

Silver-impregnated dressing

Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.

DEVICE

Telfa pad dressing

Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.

Sponsors & Collaborators

  • University of South Florida

    lead OTHER

Principal Investigators

  • Sheila Connery, MD · USF Health Morsani College of Medicine, Department of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-08-31
Completion
2018-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01697748 on ClinicalTrials.gov