Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

• ClinicalTrials.gov Identifier: NCT03887299
• Recruitment Status: Completed
• First Posted: March 22, 2019
• Results First Posted: October 5, 2021
• Last Update Posted: October 5, 2021
• Sponsor: The University of Texas Medical Branch, Galveston
• Information provided by (Responsible Party): The University of Texas Medical Branch, Galveston

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Cesarean Section Complications; Wound Breakdown; Wound Infection; Satisfaction; Surgical Wound Infection	Combination Product: ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG); Other: Standard Wound Care	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Open label randomized control trial
• Masking: None (Open Label)
• Masking Description: Data analysis will be blinded to assignment including the principal investigator.
• Primary Purpose: Treatment
• Official Title: Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Control Trial
• Actual Study Start Date: April 18, 2019
• Actual Primary Completion Date: January 18, 2020
• Actual Study Completion Date: February 28, 2020

Arms and Interventions

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 Name: Dressing containing CHG a disinfectant and antiseptic that is used for skin disinfection

Outcome Measures

Primary Outcome Measures :

1. Satisfaction and QoL Questionnaire [ Time Frame: 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.

Secondary Outcome Measures :

1. Number of Participants With Composite Wound Complication [ Time Frame: 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)
2. Number of Participants With Wound Breakdown [ Time Frame: 30 days postpartum ]
   Opening of wound incision documented in the chart at the provider's discretion(Yes or No)
3. Number of Participants That Resulted in Maternal Death [ Time Frame: 4 days postpartum ]
   Death of participant during hospital stay (Yes or No)
4. Number of Participants With Puerperal Fever [ Time Frame: 4 days postpartum ]
   Temperature > 100.4oF after first 24 hours or ≥101 oF any time. (Yes or No)
5. Provider Satisfaction [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Obstetrical population: Pregnant women undergoing cesarean section
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Texas

Ashley Salazar

Galveston, Texas, United States, 77555

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

Investigators

• Principal Investigator: Antonio F. Saad, MD; UTMB Galveston

  Study Documents (Full-Text)

Documents provided by The University of Texas Medical Branch, Galveston:

Study Protocol and Statistical Analysis Plan  [PDF] January 11, 2019

More Information

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. Review.

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.

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. Review.

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT03887299
• Other Study ID Numbers: 18-0265
• First Posted: March 22, 2019
• Results First Posted: October 5, 2021
• Last Update Posted: October 5, 2021
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by The University of Texas Medical Branch, Galveston:

Cesarean; Wound care; Wound complication; Surgical site infection

Additional relevant MeSH terms:

Infections; Communicable Diseases; Wound Infection; Surgical Wound Infection; Surgical Wound Dehiscence; Wounds and Injuries; Surgical Wound; Disease Attributes; Pathologic Processes; Postoperative Complications; Disinfectants; Anti-Infective Agents