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

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).

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Surgical Wound Infection; Wound Infection; Satisfaction; Wound Breakdown
• Intervention / Treatment: Other: Standard Wound Care; Combination product: ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)

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).

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • Ashley Salazar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 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.	Other: Standard Wound Care; Wound care will be administered as standard protocol in our institution
ACTIVE_COMPARATOR: CHG Wound Care; 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.	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 Names: Dressing containing CHG a disinfectant and antiseptic that is used for skin disinfection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction and QoL Questionnaire	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.	Postpartum wound care visit (up to 10days postpartum)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Composite Wound Complication	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)	30 days postpartum
Number of Participants With Wound Breakdown	Opening of wound incision documented in the chart at the provider's discretion(Yes or No)	30 days postpartum
Number of Participants That Resulted in Maternal Death	Death of participant during hospital stay (Yes or No)	4 days postpartum
Number of Participants With Puerperal Fever	Temperature > 100.4oF after first 24 hours or ≥101 oF any time. (Yes or No)	4 days postpartum
Provider Satisfaction	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.	Postpartum wound care visit (up to 10days postpartum)

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Principal Investigator: Antonio F. Saad, MD, UTMB Galveston

Publications and helpful links

General Publications

• Allegranzi B, Zayed B, Bischoff P, Kubilay NZ, de Jonge S, de Vries F, Gomes SM, Gans S, Wallert ED, Wu X, Abbas M, Boermeester MA, Dellinger EP, Egger M, Gastmeier P, Guirao X, Ren J, Pittet D, Solomkin JS; WHO Guidelines Development Group. New WHO recommendations on intraoperative and postoperative measures for surgical site infection prevention: an evidence-based global perspective. Lancet Infect Dis. 2016 Dec;16(12):e288-e303. doi: 10.1016/S1473-3099(16)30402-9. Epub 2016 Nov 2.
• Berg CJ, Chang J, Callaghan WM, Whitehead SJ. Pregnancy-related mortality in the United States, 1991-1997. Obstet Gynecol. 2003 Feb;101(2):289-96. doi: 10.1016/s0029-7844(02)02587-5.
• DeFrances CJ, Cullen KA, Kozak LJ. National Hospital Discharge Survey: 2005 annual summary with detailed diagnosis and procedure data. Vital Health Stat 13. 2007 Dec;(165):1-209.
• Gibbs RS. Clinical risk factors for puerperal infection. Obstet Gynecol. 1980 May;55(5 Suppl):178S-184S. doi: 10.1097/00006250-198003001-00045.
• Saad AF, Salazar AE, Allen L, Saade GR. Antimicrobial Dressing versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Controlled Trial. Am J Perinatol. 2022 Jul;39(9):951-958. doi: 10.1055/s-0040-1721112. Epub 2020 Dec 2.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2019
• Primary Completion (ACTUAL): January 18, 2020
• Study Completion (ACTUAL): February 28, 2020

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (ACTUAL): March 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Cesarean; Surgical site infection; Wound complication; Wound care
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection; Surgical Wound Dehiscence; Anti-Infective Agents; Disinfectants
• Other Study ID Numbers: 18-0265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No