Cesarean Section Complications Clinical Trial
Official title:
Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery: A Randomized Control Trial
Verified date | March 2019 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | Ashley Salazar | Galveston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston |
United States,
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
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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