The Role of Antimicrobial Foam Dressing in Prevention of Cesarean Section Wound Complications

Cesarean Section; Complications, Wound, Dehiscence Clinical Trial

Official title:

The Role of Adherent Occlusive Antimicrobial Absorbent Foam Dressing in Prevention of Cesarean Section Wound Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03136159
• Other study ID #: 207526
• Status: Completed
• Phase: N/A
• Start date: July 24, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2020
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-cesarean section wound infections are responsible for longer hospital stays, readmissions, and ultimately, increased costs to the healthcare system. Silver-containing dressings may prevent wound infections. The purpose of the current study is to determine if the use of a silver-impregnated dressing decreases the occurence of wound infection following cesarean delivery.

Description:

A single-centered, single-arm clinical trial was originally designed to investigate the effects of an adherent soft silicone anti-microbial occlusive foam silver-impregnated dressing in preventing surgical site infection (SSI) in women delivered by primary cesarean section (CS). We sought to determine if the incidence of SSIs, would be lower in patients who received a silver-impregnated dressing as compared to those who received a standard dressing, when used as part of the overall hospital protocol for reducing SSIs. Given the addition of adjunctive azithromycin antibiotic prophylaxis for those who labored or had rupture of membranes prior to undergoing a non-elective CS right at the time of initiation of the study to our institution perioperative bundle, we also elected to undertake further analyses of observational data on those with the same study inclusion criteria receiving standard dressing undergoing primary CS with subcuticular skin closure during the same time period, rather than limiting comparisons of our outcomes solely to our historical SSI rates. In order to have this comparison group, patients who declined participation in the experimental groups were selected as our non-randomized control group, given fiscal restraints precluded conducting a randomized clinical trial (RCT). Demographic, labor, delivery, intraoperative and postoperative characteristic data were collected in a de-identified fashion. Medical record review and data entry were conducted by trained research personnel. All study procedures were approved by the Investigational Review Board.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Consent to undergo cesarean delivery
• Between the ages of 18 and 45
• Primary C-section
• Subcuticular skin closure
• Able to consent, fill out study documents, and complete all study procedures and follow-up visits

Exclusion Criteria:

• Patients with an allergy to silver
• Inability to obtain informed consent
• Staples
• Repeat C-section
• Vertical skin incision
• Intrapartum fever of 100F or >

Related Conditions & MeSH terms

• Cesarean Section; Complications, Wound, Dehiscence
• Wounds and Injuries

Intervention

Device:
• Silver-impregnated antimicrobial dressing
All participants will receive an adherent soft silicone silver impregnated anti-microbial occlusive foam dressing after cesarean section. The dressing will stay on for up to seven days.

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Loyola University	Molnlycke Health Care AB

Country where clinical trial is conducted

United States, 

References & Publications (22)

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Connery SA, Downes KL, Young C. A retrospective study evaluating silver-impregnated dressings on cesarean wound healing. Adv Skin Wound Care. 2012 Sep;25(9):414-9. doi: 10.1097/01.ASW.0000419407.37323.e8. — View Citation

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Opøien HK, Valbø A, Grinde-Andersen A, Walberg M. Post-cesarean surgical site infections according to CDC standards: rates and risk factors. A prospective cohort study. Acta Obstet Gynecol Scand. 2007;86(9):1097-102. — View Citation

Owen J, Andrews WW. Wound complications after cesarean sections. Clin Obstet Gynecol. 1994 Dec;37(4):842-55. Review. — View Citation

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Smaill FM, Grivell RM. Antibiotic prophylaxis versus no prophylaxis for preventing infection after cesarean section. Cochrane Database Syst Rev. 2014 Oct 28;(10):CD007482. doi: 10.1002/14651858.CD007482.pub3. Review. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Wound Disruption and/or Infection	Rate of wound disruption and /or infection occurring by 6 weeks was compared to a historical control rate of 10%, and to a contemporary group who received a standard dressing	6 weeks postoperative