Closure of Skin in ChorioAmnionitis Research Pilot Study

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

Interventions

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.

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.

Sponsors & Collaborators

• BC Children's Hospital Research Institute

  collaborator OTHER

• University of British Columbia

  lead OTHER

Principal Investigators

• 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

• Jennifer A Hutcheon, PhD · Assistant Professor, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynaecology, University of British Columbia

• Julie E van Schalkwyk, MD · Clinical Assistant Professor, Division of General Gynaecology & Obstetrics, Department of Obstetrics and Gynaecology, University of British Columbia

• Michael WH Suen, MD · Resident, Department of Obstetrics and Gynaecology, University of British Columbia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-02-28

Primary Completion

2019-12-31

Completion

2019-12-31

Countries

• Canada

Study Locations