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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02882360
Recruitment Status : Unknown
Verified August 2016 by Debbie Penava, Lawson Health Research Institute.
Recruitment status was:  Not yet recruiting
First Posted : August 29, 2016
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Debbie Penava, Lawson Health Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Wound Infection Pregnancy Device: Kerlix-AMD Other: placebo--normal gauze Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: The Use of Antimicrobial Gauze in Pregnant Women Undergoing C-section With BMI >40 to Decrease Wound Complications by 6 Weeks postpartum--a Small Feasibility Study
Study Start Date : October 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Elective LSCS--Kerlix AMD
Kerlix-AMD applied to wound site pre-operatively (3 days) and post-operatively for 2 weeks
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

Placebo Comparator: Elective LSCS--Placebo
Normal gauze applied to wound site pre-operatively for 3 days and post-operatively for 2 weeks
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

Experimental: Labouring LSCS--Kerlix AMD
Kerlix-AMD applied to wound post-operatively for 2 weeks
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

Placebo Comparator: Labouring LSCS--Placebo
Normal gauze applied to wound post-operatively for 2 weeks
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




Primary Outcome Measures :
  1. surgical site infection [ Time Frame: 6 weeks ]
    All patients will have their wounds assessed by 6 weeks post partum to evaluate for the presence (or absence) of surgical site infection, using the Centers for Disease Control and Prevention (CDC) Nosocomial Infections Surveillance (NNIS) system criteria.


Secondary Outcome Measures :
  1. patient satisfaction [ Time Frame: 6 weeks ]
    patients will be surveyed on adherence and acceptability of application of gauze post c-section



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pregnant women at LHSC with BMI >40

Exclusion Criteria:

  • pregnant women who cannot understand English, who have a fetal demise or who have a pre-existent infected skin infection at the site of c-section

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02882360


Contacts
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Contact: Debbie Penava, MD 5196466401 Debbie.Penava@lhsc.on.ca
Contact: Jennifer Ryder, HBSc, MHS 519-685-8781 Jennifer.Ryder@lhsc.on.ca

Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Debbie Penava, MD Lawson Health Research Institute
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Responsible Party: Debbie Penava, Associate Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02882360    
Other Study ID Numbers: 106708
First Posted: August 29, 2016    Key Record Dates
Last Update Posted: August 29, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infection
Wound Infection
Wounds and Injuries