Closure of Skin in ChorioAmnionitis Research Pilot Study (CSCAR)
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|ClinicalTrials.gov Identifier: NCT01988168|
Recruitment Status : Recruiting
First Posted : November 20, 2013
Last Update Posted : May 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Chorioamnionitis Pregnancy Complications, Infectious Complications; Cesarean Section Postoperative Complications||Procedure: Suture closure Procedure: Staples closure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Closure of Skin in ChorioAmnionitis Research Pilot Study|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Suture closure
Closure of skin with a running subcuticular, absorbable monofilament suture.
Procedure: Suture closure
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 Name: 3-0 Monocryl suture (from Ethicon)
Active Comparator: Staples closure
Closure of skin with stainless-steel surgical staples.
Procedure: Staples closure
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.
- 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.
- 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
- 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.
- 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.
- 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
- Patient satisfaction [ Time Frame: 6 months post-operative ]Using the POSAS Patient Scale, patient satisfaction will be assessed.
- 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.
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): NCT01988168
|Contact: Ellen M Giesbrecht, MDfirstname.lastname@example.org|
|Canada, British Columbia|
|Children's and Women's Health Centre of British Columbia||Recruiting|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Contact: Ellen M Giesbrecht, MD 604-875-2424 email@example.com|
|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|
|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|