Back to resultsThe Use of a Silver Containing Dressing (Acticoat) on Wound Complication Rates Post Elective Cesarean Section
Primary Purpose
Surgical Wound Infection
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Acticoat PostOp
OpSite PostOp
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection focused on measuring Complications, Cesarean Section, Wound, Infection (Following Delivery)
Eligibility Criteria
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)
Sites / Locations
- Regina General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Silver containing dressing
Standard dressing
Arm Description
Subjects will have a silver containing dressing (Acticoat PostOp) applied at the time of elective cesarean section.
Subjects will have a standard dressing (OpSite PostOp) applied at the time of elective cesarean section.
Outcomes
Primary Outcome Measures
Wound complication
Composite of: wound infection treated with antibiotics, incision and drainage, wound requiring packing, or patient requiring medical attention for concerns about wound healing.
Secondary Outcome Measures
Full Information
NCT ID
NCT02288884
First Posted
November 7, 2014
Last Updated
October 12, 2016
Sponsor
Saskatchewan Health Authority - Regina Area
1. Study Identification
Unique Protocol Identification Number
NCT02288884
Brief Title
The Use of a Silver Containing Dressing (Acticoat) on Wound Complication Rates Post Elective Cesarean Section
Official Title
The Use of a Silver Containing Dressing (Acticoat) on Wound Complication Rates Post Elective Cesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saskatchewan Health Authority - Regina Area
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Complications, Cesarean Section, Wound, Infection (Following Delivery)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Silver containing dressing
Arm Type
Active Comparator
Arm Description
Subjects will have a silver containing dressing (Acticoat PostOp) applied at the time of elective cesarean section.
Arm Title
Standard dressing
Arm Type
Placebo Comparator
Arm Description
Subjects will have a standard dressing (OpSite PostOp) applied at the time of elective cesarean section.
Intervention Type
Device
Intervention Name(s)
Acticoat PostOp
Intervention Type
Device
Intervention Name(s)
OpSite PostOp
Primary Outcome Measure Information:
Title
Wound complication
Description
Composite of: wound infection treated with antibiotics, incision and drainage, wound requiring packing, or patient requiring medical attention for concerns about wound healing.
Time Frame
6 weeks post-op
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Regina General Hospital
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4P 0W5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
The Use of a Silver Containing Dressing (Acticoat) on Wound Complication Rates Post Elective Cesarean Section
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