Closure of Skin in ChorioAmnionitis Research Pilot Study

Not Applicable

• Conditions: Pregnancy Complications, Infectious; Complications; Cesarean Section; Postoperative Complications; Chorioamnionitis
• Interventions: Procedure: Suture closure; Procedure: Staples closure

• Registration Number: NCT01988168
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-20
• Study Start: 2014-02
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Suture closure	Suture closure	Closure of skin with a running subcuticular, absorbable monofilament suture.
Staples closure	Staples closure	Closure of skin with stainless-steel surgical staples.

Primary Outcome Measures

Name	Time	Method
Patient recruitment rate	1 year	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

Name	Time	Method
Follow-up rates	6 months post-operative	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	6 months post-operative	Number of women who experience a wound infection divided by the total number of eligible women who participate in the trial.
Wound disruption	6 months post-operative	Number of women who experience a wound disruption divided by the total number of eligible women who participate in the trial.
Wound cosmesis	6 months post-operative	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	6 months post-operative	Using the POSAS Patient Scale, patient satisfaction will be assessed.
Participation rate	1 year	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.

Trial Locations

Locations (1)

Children's and Women's Health Centre of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada