Antimicrobial Dressing Versus Standard Dressing in Obese Women Undergoing Cesarean Delivery

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887299
• Other study ID #: 18-0265
• Status: Completed
• Phase: Phase 4
• 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
• 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 (ReliaTect™ 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: 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).

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.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Communicable Diseases
• Infections
• Satisfaction
• Surgical Wound
• Surgical Wound Dehiscence
• Surgical Wound Infection
• Wound Breakdown
• Wound Infection
• Wounds and Injuries

Intervention

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:
• 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)