Trial record 5 of 609 for:    Open Studies | "Pregnancy Complications"

Closure of Skin in ChorioAmnionitis Research Pilot Study (CSCAR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of British Columbia
Sponsor:
Collaborator:
Child and Family Research Institute
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01988168
First received: October 31, 2013
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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 Intervention
Chorioamnionitis
Pregnancy Complications, Infectious
Complications; Cesarean Section
Postoperative Complications
Procedure: Suture closure
Procedure: Staples closure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Closure of Skin in ChorioAmnionitis Research Pilot Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Patient recruitment rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Follow-up rates [ Time Frame: 6 months post-operative ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Using the POSAS Patient Scale, patient satisfaction will be assessed.

  • Participation rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01988168

Contacts
Contact: Ellen M Giesbrecht, MD 604-872-5484 egiesbrecht@cw.bc.ca

Locations
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    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         
Sponsors and Collaborators
University of British Columbia
Child and Family 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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01988168     History of Changes
Other Study ID Numbers: H13-03009
Study First Received: October 31, 2013
Last Updated: May 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Suture Techniques
Sutures
Surgical Staplers

Additional relevant MeSH terms:
Pregnancy Complications
Pregnancy Complications, Infectious
Chorioamnionitis
Communicable Diseases
Infection
Postoperative Complications
Fetal Diseases
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Placenta Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014