NCT02288884

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Saskatchewan Health Authority - Regina Area · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Surgical Wound Infection

Interventions

Type	Name	Description
DEVICE	Acticoat PostOp
DEVICE	OpSite PostOp

Timeline

• Start date: 2011-05-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-11-11
• Last updated: 2016-10-13

Locations

1 site across 1 country: Canada