Skin Glue Cesarean Study

Study Overview
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Brief Summary
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The aim of this study is to compare cesarean incision outcomes between patients with incision closed with the Dermabond Prineo system compared to standard subcuticular suture.

Detailed Description
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The purpose of this study is to assess patient satisfaction with their incision after undergoing cesarean delivery. Patient satisfaction with their cesarean scar at 4-6 weeks after their surgery will be compared amongst women receiving skin closure with the Dermabond Prineo skin adhesive system versus standard subcuticular suture. Dermabond Prineo has been shown to have improved cosmesis outcomes in non-obstetric populations but has not yet been studied for women receiving cesarean section. In addition to scar appearance, outcomes such as wound infection, postoperative pain, and operative time will be assessed.

Official Title
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Glue Versus Subcuticular Suture for Cesarean Closure: a Randomized Control Trial

Conditions
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Cesarean Section, Complication, Wound

Intervention / Treatment
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* Device: Dermabond Prineo
* Other: Suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women age 18 years or older All women scheduled for primary or repeat cesarean deliveries All women undergoing intrapartum or antepartum cesarean delivery Pfannenstiel skin incision Birth of a live infant at time of cesarean delivery Exclusion Criteria: Vertical skin incision Cesarean hysterectomy Emergency or stat cesarean delivery excluding standard preoperative preparation measures (i.e., use of Chlorhexidine skin prep, vaginal prep, etc) Intrapartum stillbirth Planned postpartum follow up at another facility Contraindications to routine postpartum pain medications Adhesive or tape allergy

Ages Eligible for Study
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Minimum Age: 18 Years

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
Interventional Model Description: Women undergoing cesarean delivery will be recruited and randomized to skin closure with either the Dermabond Prineo system or standard subcuticular suture.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dermabond Prineo Group<br>At time of cesarean delivery, patients in the Dermabond Prineo group will undergo skin closure with the Dermabond Prineo skin adhesive system. | Device: Dermabond Prineo<br>* For subjects in the Dermabond Prineo group, the Dermabond Prineo system will be applied to the skin for skin closure under manufacturer's guidelines.<br>|
| Placebo Comparator: Suture Group<br>At time of cesarean delivery, patients in the Suture group will undergo skin closure with standard subcuticular suture. | Other: Suture<br>* For subjects in the Suture group, the skin will be closed with the standard subcuticular suture method.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient scar satisfaction | The patient's satisfaction with their cesarean incision will be assessed using the validated Patient Scar Assessment Scale (PSAS) questionnaire. The PSAS is a 6-item questionnaire that is scored on a 1 (no complaints/as normal skin) to 10 (worst imaginable/very different from normal skin) scale. Total scores range from 6-60, with a lower score indicating a greater level of patient satisfaction. | Up to 6 weeks post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of surgical site infection (SSI) | A composite of surgical site infection (SSI) will be assessed. This composite will include superficial and deep SSI, endometritis, wound separation from any cause, and/or fascial dehiscence. | Up to 6 weeks post-surgery | 
| Skin closure time | The skin closure time will be assessed. | Intraoperative | 
| Operative time | The total operative time will be assessed. | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complications, Wound, Hematoma, Surgical Incision