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

NCT ID: NCT04582045

Last Updated: 2023-01-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1064 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2021-06-15

Brief Summary

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

Detailed Description

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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.

Conditions

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D001458 D011247

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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low risk, silver impregnated

low risk, silver impregnated

silver impregnated dressing

Intervention Type DEVICE

comparison of Mepilex versus our standard techniques

low risk, border bandage

low risk, border bandage

No interventions assigned to this group

high-risk, silver impregnated

high-risk, silver impregnated

silver impregnated dressing

Intervention Type DEVICE

comparison of Mepilex versus our standard techniques

high-risk, wound vacuum

high-risk, wound vacuum

No interventions assigned to this group

Interventions

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silver impregnated dressing

comparison of Mepilex versus our standard techniques

Intervention Type DEVICE

Other Intervention Names

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Mepilex Wound vacuum

Eligibility Criteria

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Inclusion Criteria

* adult women, pregnant

Exclusion Criteria

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

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Larry Goldenberg

Role: PRINCIPAL_INVESTIGATOR

Regions Hospital

Locations

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Regions Hospital

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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A180389

Identifier Type: -

Identifier Source: org_study_id

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