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

Saskatchewan Health Authority

Status: Completed

Conditions: Surgical Wound Infection

Treatments: Device: Acticoat PostOp; Device: OpSite PostOp

Study type: Interventional

Funder types: Other

Identifiers

NCT02288884

RQhealth

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Silver containing dressing

Active Comparator group

Description:

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

Treatment:

Device: Acticoat PostOp

Standard dressing

Placebo Comparator group

Description:

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

Treatment:

Device: OpSite PostOp