Closure of Skin in ChorioAmnionitis Research Pilot Study (CSCAR)

University of British Columbia

Status: Unknown

Conditions: Postoperative Complications; Chorioamnionitis; Complications; Cesarean Section; Pregnancy Complications, Infectious

Treatments: Procedure: Suture closure; Procedure: Staples closure

Study type: Interventional

Funder types: Other

Identifiers

NCT01988168

H13-03009

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Suture closure

Experimental group

Description:

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

Treatment:

Procedure: Suture closure

Staples closure

Active Comparator group

Description:

Closure of skin with stainless-steel surgical staples.

Treatment:

Procedure: Staples closure