Clinical trial NCT01988168: Closure of Skin in ChorioAmnionitis Research Pilot Study
Official title: Closure of Skin in ChorioAmnionitis Research Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chorioamnionitis
Pregnancy Complications, Infectious
Complications; Cesarean Section
Postoperative Complications
Keywords: Suture Techniques
Sutures
Surgical Staplers
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: BC Children's Hospital Research Institute
First posted: 2013-11-20
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Patient recruitment rate
timeFrame: 1 year
Secondary outcomes:
measure: Follow-up rates
timeFrame: 6 months post-operative
measure: Wound infection
timeFrame: 6 months post-operative
measure: Wound disruption
timeFrame: 6 months post-operative
measure: Wound cosmesis
timeFrame: 6 months post-operative
measure: Patient satisfaction
timeFrame: 6 months post-operative
measure: Participation rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Children's and Women's Health Centre of British Columbia
state: British Columbia
Study officials:
affiliation: 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
name: Ellen M Giesbrecht, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynaecology, University of British Columbia
name: Jennifer A Hutcheon, PhD
role: STUDY_DIRECTOR
affiliation: Clinical Assistant Professor, Division of General Gynaecology & Obstetrics, Department of Obstetrics and Gynaecology, University of British Columbia
name: Julie E van Schalkwyk, MD
role: STUDY_DIRECTOR
affiliation: Resident, Department of Obstetrics and Gynaecology, University of British Columbia
name: Michael WH Suen, MD
role: STUDY_DIRECTOR
References: