Closure of Skin in ChorioAmnionitis Research Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Closure of Skin in ChorioAmnionitis Research Pilot Study

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

Intervention / Treatment
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* Procedure: Suture closure
* Procedure: Staples closure


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suture closure<br>Closure of skin with a running subcuticular, absorbable monofilament suture. | Procedure: Suture closure<br>* 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.<br>* Other names: 3-0 Monocryl suture (from Ethicon);|
| Active Comparator: Staples closure<br>Closure of skin with stainless-steel surgical staples. | Procedure: Staples closure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Patient satisfaction | Using the POSAS Patient Scale, patient satisfaction will be assessed. | 6 months post-operative | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suture Techniques, Sutures, Surgical Staplers