Closure of Skin in ChorioAmnionitis Research Pilot Study

NCT01988168 | Unknown

• 1 other identifier: H13-03009
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Suture Techniques; Sutures; Surgical Staplers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Follow-up rates

  6 months post-operative

• Wound infection

  6 months post-operative

• Wound disruption

  6 months post-operative

• Wound cosmesis

  6 months post-operative

• Patient satisfaction

  6 months post-operative

Study Arms (2)

Suture closure

EXPERIMENTAL

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

Procedure: Suture closure

Staples closure

ACTIVE COMPARATOR

Closure of skin with stainless-steel surgical staples.

Procedure: Staples closure

Interventions

Suture closure 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.

Also known as: 3-0 Monocryl suture (from Ethicon)

Suture closure

Staples closure 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.

Staples closure

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-Pfannenstiel incision
• Immune compromising disease
• History of keloid formation
• Chronic steroid use
• Allergy to staples
• Planned postpartum care at another facility

Sponsors & Collaborators

• University of British Columbia: lead
• BC Children's Hospital Research Institute: collaborator

Study Sites (1)

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

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Chorioamnionitis; Pregnancy Complications, Infectious; Postoperative Complications

Interventions

Sutures

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Ellen M Giesbrecht, MD

CONTACT

604-872-5484; egiesbrecht@cw.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 20, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 12, 2017

Record last verified: 2017-05

Locations

CA (1)