- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01988168
Closure of Skin in ChorioAmnionitis Research Pilot Study (CSCAR)
The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by determining the patient recruitment rate and participation rate. The objective of the full-scale trial is to determine the optimal method of skin closure after Caesarean delivery in women with chorioamnionitis, which is an acute inflammation of the membranes and chorion of the placenta, seen typically after rupture of membranes with ascending polymicrobial bacterial infection. Women in labour with chorioamnionitis will be randomized at the time of Caesarean delivery to skin closure with either staples or sutures. The women will be followed at 6 weeks and 6 months post-partum in order to establish the occurrence of surgical site infection and wound disruption, as well as evaluation of the scar and other secondary questions.
The investigators hypothesis is that closure of skin with sutures will have a rate of wound infection that is no higher than the rate of wound infection when closing skin with staples. The investigators also hypothesize that closure with sutures will have a decreased rate of wound disruption, increased patient satisfaction and decreased length of hospital stay compared to skin closure with staples.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ellen M Giesbrecht, MD
- Phone Number: 604-872-5484
- Email: egiesbrecht@cw.bc.ca
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6H 3N1
- Recruiting
- Children's and Women's Health Centre of British Columbia
-
Contact:
- Ellen M Giesbrecht, MD
- Phone Number: 604-875-2424
- Email: egiesbrecht@cw.bc.ca
-
Principal Investigator:
- Ellen M Giesbrecht, MD
-
Sub-Investigator:
- Jennifer A Hutcheon, PhD
-
Sub-Investigator:
- Julie E van Schalkwyk, MD
-
Sub-Investigator:
- Michael WH Suen, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of chorioamnionitis (Fever ≥ 38.0°C AND at least TWO of: Maternal tachycardia: Heart rate > 100bpm, Fetal tachycardia: Baseline heart rate > 160bpm, Uterine tenderness, Foul smelling / purulent vaginal discharge, White Blood Cell count > 15,000 cells/mm3)
- Caesarean delivery with Pfannenstiel incision
- Pregnancies >24 weeks
- Scheduled or non-elective procedures
- Primary or repeat Caesarean delivery
- No restrictions based on BMI
- No exclusions due to DM (GDM or non GDM)
- No exclusions due to multiple gestation pregnancy
Exclusion Criteria:
- Non-Pfannenstiel incision
- Immune compromising disease
- History of keloid formation
- Chronic steroid use
- Allergy to staples
- Planned postpartum care at another facility
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Suture closure
Closure of skin with a running subcuticular, absorbable monofilament suture.
|
A running subcuticular suture is placed by taking horizontal bites through the papillary dermis on alternating sides of the wound.
An absorbable suture is used and left in place until degraded and absorbed by the patient's tissues.
Other Names:
|
ACTIVE_COMPARATOR: Staples closure
Closure of skin with stainless-steel surgical staples.
|
Surgical stapling devices re-appose skin edges with stainless steel or titanium staples.
A second operator everts the wound skin edges while the operator applies staples along the incision.
Staples can be removed on post-operative day 2 or 3, or delayed further according the surgeon preference based on patient characteristics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient recruitment rate
Time Frame: 1 year
|
The patient recruitment rate will be calculated as the total number of women successfully recruited to the trial divided by the total duration of the trial.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Follow-up rates
Time Frame: 6 months post-operative
|
Number of women successfully contacted at 6 weeks and at 6 months post-partum divided by the total number of women randomized in the trial
|
6 months post-operative
|
Wound infection
Time Frame: 6 months post-operative
|
Number of women who experience a wound infection divided by the total number of eligible women who participate in the trial.
|
6 months post-operative
|
Wound disruption
Time Frame: 6 months post-operative
|
Number of women who experience a wound disruption divided by the total number of eligible women who participate in the trial.
|
6 months post-operative
|
Wound cosmesis
Time Frame: 6 months post-operative
|
Wound cosmesis will be assessed using the POSAS Observer scale, which is directed at physicians, and the POSAS Patient scale, which is directed at patients
|
6 months post-operative
|
Patient satisfaction
Time Frame: 6 months post-operative
|
Using the POSAS Patient Scale, patient satisfaction will be assessed.
|
6 months post-operative
|
Participation rate
Time Frame: 1 year
|
The trial participation rate will be calculated as the percentage of eligible women who agreed to participate in the trial divided by the total number of eligible women approached to participate in the trial.
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ellen M Giesbrecht, MD, Clinical Assistant Professor, Division of General Gynaecology & Obstetrics, Department of Obstetrics and Gynaecology, University of British Columbia; Site Head, Department of Obstetrics, BC Women's Hospital
- Study Director: Jennifer A Hutcheon, PhD, Assistant Professor, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynaecology, University of British Columbia
- Study Director: Julie E van Schalkwyk, MD, Clinical Assistant Professor, Division of General Gynaecology & Obstetrics, Department of Obstetrics and Gynaecology, University of British Columbia
- Study Director: Michael WH Suen, MD, Resident, Department of Obstetrics and Gynaecology, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H13-03009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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