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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04582045
Enrollment
1064
Registered
2020-10-09
Start date
2019-03-01
Completion date
2021-06-15
Last updated
2023-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

D001458, D011247

Keywords

infection, bandage, cesarean section

Brief summary

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

Detailed 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.

Interventions

DEVICEsilver impregnated dressing

comparison of Mepilex versus our standard techniques

Sponsors

HealthPartners Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 55 Years

Inclusion criteria

* adult women, pregnant

Exclusion criteria

* \<18 years old * surgery complicated by non-routine surgeries (Such as appendectomy)

Design outcomes

Primary

MeasureTime frameDescription
Infection Rate30 days from surgeryrate of post operative infection

Countries

United States

Participant flow

Participants by arm

ArmCount
Low Risk, Silver Impregnated
low risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques
446
Low Risk, Border (Traditional) Bandage
low risk, border (traditional) bandage standard border wound bandage
440
High-risk, Silver Impregnated
high-risk, silver impregnated silver impregnated dressing: comparison of Mepilex versus our standard techniques
95
High-risk, Negative-pressure Wound Vacuum
high-risk, negative-pressure wound vacuum Commercially available negative-pressure wound vacuum
83
Total1,064

Baseline characteristics

CharacteristicLow Risk, Silver ImpregnatedLow Risk, Border (Traditional) BandageHigh-risk, Silver ImpregnatedHigh-risk, Negative-pressure Wound VacuumTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
446 Participants440 Participants95 Participants83 Participants1064 Participants
Enrollment Parameters446 Participants440 Participants95 Participants83 Participants1064 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
67 Participants66 Participants14 Participants12 Participants159 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
379 Participants374 Participants81 Participants71 Participants905 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
85 Participants79 Participants17 Participants14 Participants195 Participants
Race (NIH/OMB)
Black or African American
183 Participants185 Participants40 Participants36 Participants444 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
178 Participants176 Participants38 Participants33 Participants425 Participants
Region of Enrollment
United States
446 participants440 participants95 participants83 participants1064 participants
Sex: Female, Male
Female
446 Participants440 Participants95 Participants83 Participants1064 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 4460 / 4400 / 950 / 83
other
Total, other adverse events
6 / 4463 / 4402 / 953 / 83
serious
Total, serious adverse events
24 / 44613 / 4405 / 951 / 83

Outcome results

Primary

Infection Rate

rate of post operative infection

Time frame: 30 days from surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Low Risk, Silver ImpregnatedInfection Rate17 Participants
Low Risk, Border BandageInfection Rate18 Participants
High-risk, Silver ImpregnatedInfection Rate5 Participants
High-risk, Wound VacuumInfection Rate5 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026