MedTrace Logo

Kerlix for Pregnant Women With Elevated BMI to Prevent Wound Infection by 6 Weeks Post Partum

NCT02882360 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-08-29

No results posted yet for this study

Summary

Pregnant women with BMI\>40 will be approached for participation in a study to reduce the rate of post-operative wound infection from C-section. Women will be randomized to a commonly used wound product (Kerlix-AMD) which consists of a PHMB-impregnated gauze versus normal gauze, and rates of post-operative surgical site infection will be assessed. Women with a planned procedure will also be randomized to applying Kerlix versus gauze for 3 days pre-operatively to determine if this improves outcomes as well.

Conditions

  • Obesity
  • Wound Infection
  • Pregnancy

Interventions

DEVICE

Kerlix-AMD

Application of PHMB impregnated gauze pre-operatively (for booked C-sections) and post-operatively for all patients with LSCS. Gauze to be changed daily or more frequently if damp/blood-tinged

OTHER

placebo--normal gauze

Application of gauze pre-operatively (for booked C-sections) and post-operatively for all patients with LSCS. Gauze to be changed daily or more frequently if damp/blood-tinged

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Debbie Penava, MD · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
15 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-01-31
Completion
2018-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02882360 on ClinicalTrials.gov