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: Unknown
• Conditions: Postoperative Complications; Chorioamnionitis; Pregnancy Complications, Infectious; Complications; Cesarean Section
• Intervention / Treatment: Procedure: Suture closure; Procedure: Staples closure

• Study Type: Interventional
• Enrollment (Anticipated): 60
• 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

• Canada
  • 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: No
• Genders Eligible for Study: Female

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient recruitment rate	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	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	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	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	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	Using the POSAS Patient Scale, patient satisfaction will be assessed.	6 months post-operative
Participation rate	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: University of British Columbia
• Collaborators: BC Children's Hospital Research Institute
• 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: February 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: October 31, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (ESTIMATE): November 20, 2013

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Sutures; Suture Techniques; Surgical Staplers
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Fetal Diseases; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Chorioamnionitis; Postoperative Complications; Pregnancy Complications; Pregnancy Complications, Infectious
• Other Study ID Numbers: H13-03009