NCT03887299

Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Control Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 154 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This will be an open label pilot randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have standard wound dressing care or chlorohexidine gluconate (CHG) impregnated wound dressing (ReliaTect™ Post-Op Dressing).

Detailed description

Subjects requiring cesarean delivery and without exclusion criteria will be informed by the obstetrical team about the study and asked for permission to contact the study personnel. Written informed consent will be obtained by person-to-person contact. The research staff will be responsible for the informed consent. Subjects who agree to participate in the study will be randomized to one of the two groups below in a 1/1 allocation: * Standard Wound Care: Wound dressing and care as per our current practice. Compression dressing consisting of gauze, tefla and adhesive tape will be placed intraoperatively. Dressing will be removed after 24 hours from surgery completion and subjects will have an absorption pad with overlying garments for the remaining postoperative days until standard postoperative visit for wound check. * CHG Wound Care: ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions (Appendix A) intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7. The remainder of the subjects' care will be similar for both arms and will follow current standard clinical practice at the University of Texas Medical Branch (UTMB).

Conditions

• Cesarean Section Complications
• Wound Breakdown
• Wound Infection
• Satisfaction
• Surgical Wound Infection

Interventions

Type	Name	Description
COMBINATION_PRODUCT	ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)	Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7
OTHER	Standard Wound Care	Wound care will be administered as standard protocol in our institution

Timeline

• Start date: 2019-04-18
• Primary completion: 2020-01-18
• Completion: 2020-02-28
• First posted: 2019-03-22
• Last updated: 2021-10-05
• Results posted: 2021-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study