Recruiting

Closure of Skin

Sponsor:

University of British Columbia

Code:

NCT01988168

Conditions

Chorioamnionitis

Pregnancy Complications, Infectious

Complications; Cesarean Section

Postoperative Complications

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Suture closure

Staples closure

Study Details

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 ID

NCT01988168

Start date

Feb, 2014

Status verified date

May, 2017

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Suture closure

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

active comparator: Staples closure

Closure of skin with stainless-steel surgical staples.

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.

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.

Primary outcome measure

  • Patient recruitment rate [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Ellen M Giesbrecht, MD

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

Locations

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

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Ellen M Giesbrecht, MD

604-875-2424egiesbrecht@cw.bc.ca

Principal Investigator:

Ellen M Giesbrecht, MD

More Information

Sponsor

University of British Columbia

Last update posted

May 12, 2017

Last verified

May, 2017

Keywords

  • Suture Techniques
  • Sutures
  • Surgical Staplers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2017-05-12.