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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03887299
Other study ID # 18-0265
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 18, 2019
Est. completion date February 28, 2020

Study information

Verified date March 2019
Source The University of Texas Medical Branch, Galveston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 (ReliaTectâ„¢ Post-Op Dressing).


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: ReliaTectâ„¢ 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).


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date February 28, 2020
Est. primary completion date January 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Intervention

Combination Product:
ReliaTectâ„¢ 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:
Standard Wound Care
Wound care will be administered as standard protocol in our institution

Locations

Country Name City State
United States Ashley Salazar Galveston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Medical Branch, Galveston

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Gibbs RS. Clinical risk factors for puerperal infection. Obstet Gynecol. 1980 May;55(5 Suppl):178S-184S. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of Participants With Composite Wound Complication 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) 30 days postpartum
Secondary Number of Participants With Wound Breakdown Opening of wound incision documented in the chart at the provider's discretion(Yes or No) 30 days postpartum
Secondary Number of Participants That Resulted in Maternal Death Death of participant during hospital stay (Yes or No) 4 days postpartum
Secondary Number of Participants With Puerperal Fever Temperature > 100.4oF after first 24 hours or =101 oF any time. (Yes or No) 4 days postpartum
Secondary Provider Satisfaction 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.
Postpartum wound care visit (up to 10days postpartum)
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