Skip to main content
OpenTrials
Completed

NCT Number: NCT02288884

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Acticoat PostOp

Device

OpSite PostOp

Device

Primary outcomes

  1. Wound complication

    Time frame: 6 weeks post-op

    Composite of: wound infection treated with antibiotics, incision and drainage, wound requiring packing, or patient requiring medical attention for concerns about wound healing.

Sponsors and collaborators

Lead sponsor

Saskatchewan Health Authority - Regina Area

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2014
Registry last updated
Oct 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.