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

Surgical Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02288884
• Other study ID #: RQhealth
• Status: Completed
• Phase: N/A
• First received: November 7, 2014
• Last updated: October 12, 2016
• Start date: May 2011
• Est. completion date: October 2016

Study information

• Verified date: April 2016
• Source: Regina Qu'Appelle Health Region
• Contact: n/a
• Is FDA regulated: No
• Health authority: Regina Qu'Appelle Health Region Research Ethics Board, Regina, Canada:
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Device:
• Acticoat PostOp

• OpSite PostOp

Locations

Country	Name	City	State
Canada	Regina General Hospital	Regina	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
Regina Qu'Appelle Health Region

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks post-op	No