NCT03887299

Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

Completed Phase 4 Results posted Last updated 5 October 2021

What this trial tests

Phase 4 trial testing ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG) in Cesarean Section Complications in 154 participants. Completed in 28 February 2020.

Timeline

18 April 2019

Primary endpoint
18 January 2020

28 February 2020

Quick facts

Lead sponsor	The University of Texas Medical Branch, Galveston
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	154
Start date	18 April 2019
Primary completion	18 January 2020
Estimated completion	28 February 2020
Sites	1 location across United States

Drugs / interventions tested

• ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)
• Standard Wound Care

Conditions studied

• Cesarean Section Complications — all drugs for Cesarean Section Complications →
• Wound Breakdown — all drugs for Wound Breakdown →
• Wound Infection — all drugs for Wound Infection →
• Satisfaction — all drugs for Satisfaction →

Sponsor

The University of Texas Medical Branch, Galveston

Who can join

Adults 18 to 50, female only, with Cesarean Section Complications or Wound Breakdown. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Satisfaction and QoL Questionnaire Primary · Postpartum wound care visit (up to 10days postpartum)

We will be assessing through a survey patient satisfaction concerning dressing received and assess the quality of life while receiving either intervention (5 point Richter scale). A maximum score of 5: Strongly agree and a minimum score of 1: Strongly disagree. A higher score means a better outcome.

Group	Value	95% CI
Standard Wound Care	49	20 – 55
CHG Wound Care	52	12 – 55

Number of Participants With Composite Wound Complication Secondary · 30 days postpartum

Defined as presence of any of the following within 30 days from surgery: Wound infection: Presence of either superficial or deep incisional SSI described as cellulitis/erythema and induration around the incision or purulent discharge from the incision site, with or without fever, such as necrotizing fasciitis (diagnosed based on necrotizing wound infection). Wound hematoma, seroma, or breakdown alone. (yes or No)

Group	Value	95% CI
Standard Wound Care	5
CHG Wound Care	9

Number of Participants With Wound Breakdown Secondary · 30 days postpartum

Opening of wound incision documented in the chart at the provider's discretion(Yes or No)

Group	Value	95% CI
Standard Wound Care	1
CHG Wound Care	0

Number of Participants That Resulted in Maternal Death Secondary · 4 days postpartum

Death of participant during hospital stay (Yes or No)

Group	Value	95% CI
Standard Wound Care	0
CHG Wound Care	0

Number of Participants With Puerperal Fever Secondary · 4 days postpartum

Temperature \> 100.4oF after first 24 hours or ≥101 oF any time. (Yes or No)

Group	Value	95% CI
Standard Wound Care	0
CHG Wound Care	1

Provider Satisfaction Secondary · Postpartum wound care visit (up to 10days postpartum)

Assessing health care providers opinion on the dressing care (5 point Richter scale). A maximum score of 5: Strongly agree and a minimum score of 1: Strongly disagree. A higher score means a better outcome.

Group	Value	95% CI
Standard Wound Care	17	5 – 25
CHG Wound Care	21	5 – 25

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Antimicrobial Dressing versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial.
   Saad AF, Salazar AE, Allen L, Saade GR. · · 2022 · cited 2× · PMID 33264808 · DOI 10.1055/s-0040-1721112