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OpenTrials
Completed

NCT Number: NCT03887299

Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

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).

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ashley Salazar

Galveston, Texas, 77555, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Standard Wound Care

Other

Wound care will be administered as standard protocol in our institution

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Official study title

Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Control Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 22, 2019
Registry last updated
Oct 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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