Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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).

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887299


Locations
Layout table for location information
United States, Texas
Ashley Salazar
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Layout table for investigator information
Principal Investigator: Antonio F. Saad, MD UTMB Galveston
  Study Documents (Full-Text)

Documents provided by The University of Texas Medical Branch, Galveston:
Publications:
Layout table for additonal information
Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03887299    
Other Study ID Numbers: 18-0265
First Posted: March 22, 2019    Key Record Dates
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

Layout table for additional information
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:
Layout table for 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