Topical Silver for Prevention of Wound Infection After Cesarean Delivery

NCT ID: NCT01169064

Last Updated: 2017-05-30

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

475 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A common concern in any surgical procedure is the occurrence of infection. Silver-containing treatments are popular and used in wound treatment; however, there is presently little evidence of the effectiveness of silver-containing treatment for the prevention of obstetrical wound infection. We plan to investigate the rate of infection in women experiencing cesarean sections at Vanderbilt University Medical Center (VUMC) by comparing the infection rate based on a randomized choice of silver-containing wound dressings to soft cloth adhesive wound dressings.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wound Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Silver-containing surgical dressing

Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver

Group Type ACTIVE_COMPARATOR

Silver-containing surgical dressing

Intervention Type DEVICE

Dressing placed over surgical incision and remain for 3-5 days

Cloth adhesive dressing

Soft cloth adhesive wound dressing

Group Type ACTIVE_COMPARATOR

Cloth adhesive dressing

Intervention Type DEVICE

Cloth adhesive dressing placed over surgical incision and remains for 3-5 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Silver-containing surgical dressing

Dressing placed over surgical incision and remain for 3-5 days

Intervention Type DEVICE

Cloth adhesive dressing

Cloth adhesive dressing placed over surgical incision and remains for 3-5 days

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Acticoat Medipore

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Cesarean delivery with pfannenstiel incision

Exclusion Criteria

* Incision other than pfannenstiel
* Silver allergy
* Inability to provide informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kelly Bennett

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kelly A. Bennett, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Vanderbilt University Hospital

Nashville, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VUMFM-100785

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Mepilex Cesarean Delivery Trial
NCT07066254 NOT_YET_RECRUITING NA