The Use of a Silver Containing Dressing (Acticoat) on Wound Complication Rates Post Elective Cesarean Section

NCT ID: NCT02288884

Last Updated: 2016-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2016-10-31

Brief Summary

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The purpose of this study is to determine the effect of a silver containing dressing (Acticoat Post-Op) compared to a standard dressing (OpSite PostOp) on post elective cesarean section wound complications in obese women (BMI \>35).

Detailed Description

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Women scheduled for an elective cesarean section at term will be recruited to participate in this study. The investigators plan to recruit 100 women. Baseline demographic information will be obtained at the pre-op visit. Eligible subjects will be randomized to received a silver containing dressing (Acticoat PostOp) or the standard dressing (OpSite PostOp). A randomization table will be computer generated in blocks of 20. A sealed opaque envelope containing the assigned dressing will accompany the patient to the operating room. Standard antibiotic prophylaxis will be provided prior to skin incision. A subcuticular suture will be used for skin closure. At the time of skin closure, the envelope will be opened and the assigned dressing will be applied. The dressing will only be changed if it is saturated. The dressing will be removed at the time of discharge from hospital. A questionnaire regarding wound complications will be completed at the time of discharge from hospital, at 2 weeks post-op and 6 weeks post-op.

Conditions

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Surgical Wound Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Silver containing dressing

Subjects will have a silver containing dressing (Acticoat PostOp) applied at the time of elective cesarean section.

Group Type ACTIVE_COMPARATOR

Acticoat PostOp

Intervention Type DEVICE

Standard dressing

Subjects will have a standard dressing (OpSite PostOp) applied at the time of elective cesarean section.

Group Type PLACEBO_COMPARATOR

OpSite PostOp

Intervention Type DEVICE

Interventions

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Acticoat PostOp

Intervention Type DEVICE

OpSite PostOp

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women scheduled for elective cesarean section
* BMI \>35 at the pre-op visit
* consent to participate

Exclusion Criteria

* allergy to silver
* immunocompromised (HIV/AIDS, on immunosuppressive medications)
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Saskatchewan Health Authority - Regina Area

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Regina General Hospital

Regina, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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RQhealth

Identifier Type: -

Identifier Source: org_study_id

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