Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

NCT03887299 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: 18-0265
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Cesarean; Wound care; Wound complication; Surgical site infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of Participants With Composite Wound Complication

  30 days postpartum

• Number of Participants With Wound Breakdown

  30 days postpartum

• Number of Participants That Resulted in Maternal Death

  4 days postpartum

• Number of Participants With Puerperal Fever

  4 days postpartum

• Provider Satisfaction

  Postpartum wound care visit (up to 10days postpartum)

Study Arms (2)

Standard Wound Care

PLACEBO COMPARATOR

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

CHG Wound Care

ACTIVE COMPARATOR

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)

Interventions

ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG) COMBINATION_PRODUCT

Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7

Also known as: Dressing containing CHG a disinfectant and antiseptic that is used for skin disinfection

CHG Wound Care

Standard Wound Care OTHER

Wound care will be administered as standard protocol in our institution

Standard Wound Care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Obstetrical population: Pregnant women undergoing cesarean section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

Ashley Salazar

Galveston, Texas, 77555, United States

Location

Related Publications (5)

• 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.

  PMID: 27816414 BACKGROUND

• 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.

  PMID: 12576252 BACKGROUND

• 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.

  PMID: 18350768 BACKGROUND

• Gibbs RS. Clinical risk factors for puerperal infection. Obstet Gynecol. 1980 May;55(5 Suppl):178S-184S. doi: 10.1097/00006250-198003001-00045.

  PMID: 6990333 BACKGROUND

• 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.

  PMID: 33264808 DERIVED

MeSH Terms

Conditions

Surgical Wound Dehiscence; Wound Infection; Personal Satisfaction; Surgical Wound Infection

Interventions

Chromogranins

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Behavior

Intervention Hierarchy (Ancestors)

Nerve Tissue Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors

Results Point of Contact

• Title: Antonio F Saad
• Organization: University of Texas Medical Branch Galveston

afsaad@utmb.edu

4097476646

Study Officials

• Antonio F. Saad, MD

  UTMB Galveston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analysis will be blinded to assignment including the principal investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label randomized control trial

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 22, 2019
• Study Start: April 18, 2019
• Primary Completion: January 18, 2020
• Study Completion: February 28, 2020
• Last Updated: October 5, 2021
• Results First Posted: October 5, 2021

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)