Ashley Salazar
Galveston, Texas, 77555, United States
NCT Number: NCT03887299
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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Notify Me18 year–50 year
Female
Interventional
Phase 4
Galveston, Texas, 77555, United States
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:
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Wound care will be administered as standard protocol in our institution
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.
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)
Time frame: 30 days postpartum
Opening of wound incision documented in the chart at the provider's discretion(Yes or No)
Time frame: 4 days postpartum
Death of participant during hospital stay (Yes or No)
Time frame: 4 days postpartum
Temperature > 100.4oF after first 24 hours or ≥101 oF any time. (Yes or No)
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.
The University of Texas Medical Branch, Galveston
Other
Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Control Trial
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