Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

This study be a randomized double-blinded feasibility study to improve the rates of wound complications post-C/S in women with a BMI >40. It will be conducted out of a single tertiary care centre in London, Ontario. The women will be randomized to one of two treatment groups, either Kerlix AMD gauze or Kerlix plain gauze (Kendall, Covidien AG, Mansfield MA). This randomization will be performed by validated computer based randomization software (www.sealedenvelope.com). The patients, staff and physicians will be blinded to the assigned groups. After consenting to the study, at the time of their C/S, participants will be assigned a sealed envelope which will contain their assigned group. All patients with a BMI >40 who qualify for the study that are seen in the outpatient clinics at our centre will be approached about their participation in the study. Patients that meet the study criteria who are seen for the first time after being admitted to the labor and delivery ward will be consented for the study, and if they do not require a C/S, then this consent will be disregarded. Participants who have a planned C/S will also be randomized to receive treatment with either AMD or plain gauze for three days prior to their C/S. This requires placement of a piece of gauze, randomly assigned, under the pannus in the area of the anticipated incision. This gauze is to be changed daily for three days prior to the booked C/S. These patients will continue to receive the same gauze they were assigned to post-operatively. As part of routine care peri-operatively, all patients receive 3g of Ancef 15-60 min prior to skin incision (Ayres-de-Campos), and their skin is prepped with 2% chlorohexidine (Lee I) (2%, Laboratoire Atlas Inc, Montreal, QC) . The subcutaneous layer will be closed at the end of the case using absorbable sutures (Chelmow). The skin will be closed with a running absorbable suture in the subcuticular layer (Clay). At the end of the C/S, all patients will have their respective gauze placed over their incision, with a Tegaderm (3M Healthcare, St. Paul, MN) or pressure dressing placed on top. This outer occlusive dressing will be removed poat-operative day )POD) 1, unless it becomes saturated before then. Their gauze will be replaced daily, or more frequently if it becomes saturated. The incisions will be inspected daily by a physician while they are in hospital. The Centers for Disease Control and Prevention (CDC) Nosocomial Infections Surveillance (NNIS) system criteria will be used to diagnose wound infections. They will be discharged home with enough gauze for daily dressing changes for two weeks, as well as an information sheet outlining signs and symptoms to be aware of, or reasons to return to hospital. Their incision will be inspected by a physician at one, two and six weeks post-operatively. If at any point over the duration of the study they develop signs or symptoms of infection or any other complications, they will be investigated and treated accordingly. This may involve taking a picture of the wound to track whether or not cellulitis or infection is spreading or tracking; this will always be with your explicit consent and to track wound progression. At six weeks they will also complete a qualitative survey investigating their subjective experience with the gauze and the protocol. A cost analysis will also be performed. All data will be collected using data collection sheets. The newest version of Statistical Package for Social Sciences (SPSS) Statistical analysis software will be used to conduct data analysis, using formulas such as student t-test for continuous data and chi-squared for nominal data. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


NCT number NCT02882360
Study type Interventional
Source Lawson Health Research Institute
Contact Debbie Penava, MD
Phone 5196466401
Email Debbie.Penava@lhsc.on.ca
Status Not yet recruiting
Phase Phase 4
Start date October 2016
Completion date December 2018

See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2