Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Cesarean Section Complications; Wound Breakdown; Satisfaction; Surgical Wound Infection; Wound Infection

Treatments: Combination Product: ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG); Other: Standard Wound Care

Study type: Interventional

Funder types: Other

Identifiers

NCT03887299

18-0265

Details and patient eligibility

About

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).

Full 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).

Enrollment: 154 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-50 years of age.
• Women ≥ 24 weeks' viable gestation.
• To undergo cesarean delivery.
• Admission BMI ≥ 35.

Exclusion criteria

• Patient unwilling or unable to provide consent.
• No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery.
• Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other.
• Decision not to have skin closure (e.g. secondary wound closure, mesh closure).
• Current skin infection.
• Coagulopathy.
• High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery).
• Known allergy to CHG.
• Incarcerated individuals.
• Chorioamnionitis.
• Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 2 patient groups, including a placebo group

Standard Wound Care

Placebo Comparator group

Description:

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.

Treatment:

Other: Standard Wound Care

CHG Wound Care

Active Comparator group

Description:

ReliaTect™ Post-Op Dressing will be applied as per the manufacturer's instructions intraoperatively. The dressing will be in place until the postoperative clinic visit on postoperative day 7.

Treatment:

Combination Product: ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)