Effect of Prophylactic Negative Pressure Versus Silver Impregnated Silicone Bandage on C-Section Infection Rates

D001458 Clinical Trial

Official title:

Effect of Prophylactic Negative Pressure Versus Silver Impregnated Silicone Bandage on Cesarean Section Surgical Site Infection Rate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582045
• Other study ID #: A180389
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: June 15, 2021

Study information

• Verified date: December 2021
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Effect of Prophylactic Negative Pressure versus Silver Impregnated Silicone Bandage on Cesarean Section Surgical Site Infection Rate

Description:

Comparison of effect of Prophylactic Negative Pressure versus Silver Impregnated Silicone Bandage on Cesarean Section Surgical Site Infection Rate as compared to wound vacuum in high risk women and traditional border dressing in low risk women in adult women having uncomplicated cesarean section.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1064
• Est. completion date: June 15, 2021
• Est. primary completion date: March 1, 2021
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• adult women, pregnant

Exclusion Criteria:

• <18 years old

• surgery complicated by non-routine surgeries (Such as appendectomy)

Related Conditions & MeSH terms

• D001458
• D011247
• Infections

Intervention

Device:
• silver impregnated dressing
comparison of Mepilex versus our standard techniques

Locations

Country	Name	City	State
United States	Regions Hospital	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infection Rate	rate of post operative infection	30 days from surgery