NCT02288884

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

April 1, 2016

Enrollment Period

5.4 years

First QC Date

November 7, 2014

Last Update Submit

October 12, 2016

Conditions

Surgical Wound Infection

Keywords

ComplicationsCesarean SectionWoundInfection (Following Delivery)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Silver containing dressing

ACTIVE COMPARATOR

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

Device: Acticoat PostOp

Standard dressing

PLACEBO COMPARATOR

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

Device: OpSite PostOp

Interventions

Acticoat PostOpDEVICE
Silver containing dressing
OpSite PostOpDEVICE
Standard dressing

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women scheduled for elective cesarean section
  • BMI \>35 at the pre-op visit
  • consent to participate

You may not qualify if:

  • allergy to silver
  • immunocompromised (HIV/AIDS, on immunosuppressive medications)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

Location

MeSH Terms

Conditions

Surgical Wound InfectionWounds and InjuriesInfections

Condition Hierarchy (Ancestors)

Wound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2014

First Posted

November 11, 2014

Study Start

May 1, 2011

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-04

Locations

CA(1)