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Antimicrobial Dressing versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Controlled TrialFunding This trial was funded by Eloquest Healthcare, Inc., MI. The funder did not have any role in the conduct of the trial, analysis of the data, or drafting of this manuscript.
Objective This study aimed to evaluate the effect of a novel antimicrobial dressing on patient satisfaction and health-related quality of life (HRQoL) following a cesarean delivery.
Study Design This was an open-label, single-center, two-arm randomized controlled trial. This study was done at the tertiary center, maternal unit, Galveston, TX. Pregnant women with body mass indices ≥35 kg/m2 were screened for eligibility. Women were randomized to ReliaTect Post-Op Dressing (RELIATECT) or standard wound dressing (STANDARD). Primary outcome was patient satisfaction and HRQoL using validated questionnaires. Secondary outcomes were provider satisfaction, surgical site infection (SSI) rates, and wound complications.
Results In total, 160 women were randomized. Population characteristics were not significant among groups. RELIATECT dressing group had an overall higher score of satisfaction and HRQoL compared with STANDARD group. Women in the RELIATECT group reported less incision odor and incisional pain. Compared with the STANDARD group, most women in RELIATECT dressing group reported better daily activities, self-esteem, personal hygiene, body image, and sleep. Providers reported that the RELIATECT dressing allowed better assessment of the surgical incision site, allowed patients to shower early, and did observe less wound dressing leakage. No differences were found in other secondary end points.
Conclusion Postcesarean RELIATECT dressing for wound care in pregnant women with obesity had better patient and provider satisfaction as well as better HRQoL scores. Further, level 1 evidence is needed to assess its impact on SSI rates and wound complication, as this trial was not powered to accomplish this goal.
This study was conducted to evaluate RELIATECT on patient satisfaction and HRQoL following a cesarean.
Post-cesarean RELIATECT dressing for wound care had better HRQoL and patient and provider satisfaction scores.
This is the first randomized controlled trial evaluating RELIATECT dressing in obese pregnant women undergoing cesarean section.
Clinical Trial Registration
ClinicalTrials.gov; date of registration: March 22, 2019; date of first enrollment: April 18, 2019; available at: https://clinicaltrials.gov/ct2/show/NCT03887299
A.F.S., A.E.S., and G.R.S. conceived the study and editing the final manuscript. A.F.S. and G.R.S. were involved in data analysis, interpretation of data, drafting of manuscript, and critical review and editing the manuscript. A.F.S. and L.A. were involved in data abstraction/extraction. L.A. was involved in data abstraction. All authors approved the final version for submission.
After review and determination by the University of Texas Medical Branch Galveston Hospital Institutional Review Board (Name: “Institutional Review Board,” 301 University Boulevard, Galveston, TX 77550-0158), our research project (IRB protocol # 18-0265) was found to meet the criteria for approval on March 8, 2019. Written informed consent was obtained from all participants prior to inclusion and randomization in the study. Participants were identified by number, not by name.
Received: 09 September 2020
Accepted: 06 October 2020
02 December 2020 (online)
© 2020. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)
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