Closure of Skin in ChorioAmnionitis Research Pilot Study

Postoperative Complications Clinical Trial

— CSCAR  

Official title:

Closure of Skin in ChorioAmnionitis Research Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01988168
• Other study ID #: H13-03009
• Status: Recruiting
• Phase: N/A
• First received: October 31, 2013
• Last updated: May 11, 2017
• Start date: February 2014
• Est. completion date: December 2019

Study information

• Verified date: May 2017
• Source: University of British Columbia
• Contact: Ellen M Giesbrecht, MD
• Phone: 604-872-5484
• Email: egiesbrecht[@]cw.bc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chorioamnionitis
• Complications; Cesarean Section
• Postoperative Complications
• Pregnancy Complications
• Pregnancy Complications, Infectious

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Children's and Women's Health Centre of British Columbia	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	BC Children's Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

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