Closure of Skin in ChorioAmnionitis Research Pilot Study

NCT ID: NCT01988168

Last Updated: 2017-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2019-12-31

Brief Summary

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.

Conditions

Chorioamnionitis; Pregnancy Complications, Infectious; Complications; Cesarean Section; Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Suture closure

Closure of skin with a running subcuticular, absorbable monofilament suture.

Group Type: EXPERIMENTAL

Suture closure

Intervention Type: PROCEDURE

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.

Staples closure

Closure of skin with stainless-steel surgical staples.

Group Type: ACTIVE_COMPARATOR

Staples closure

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

3-0 Monocryl suture (from Ethicon)

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

BC Children's Hospital Research Institute

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Ellen Giesbrecht

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ellen M Giesbrecht, MD

Role: PRINCIPAL_INVESTIGATOR

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

Jennifer A Hutcheon, PhD

Role: STUDY_DIRECTOR

Assistant Professor, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynaecology, University of British Columbia

Julie E van Schalkwyk, MD

Role: STUDY_DIRECTOR

Clinical Assistant Professor, Division of General Gynaecology & Obstetrics, Department of Obstetrics and Gynaecology, University of British Columbia

Michael WH Suen, MD

Role: STUDY_DIRECTOR

Resident, Department of Obstetrics and Gynaecology, University of British Columbia

Locations

Children's and Women's Health Centre of British Columbia

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ellen M Giesbrecht, MD

Role: CONTACT

egiesbrecht@cw.bc.ca

604-872-5484

Facility Contacts

Ellen M Giesbrecht, MD

Role: primary

egiesbrecht@cw.bc.ca

604-875-2424

Other Identifiers

H13-03009

Identifier Type: -

Identifier Source: org_study_id