Comparison of Adhesive Latch Device to Subcuticular Skin Closure at the Time of Cesarean Section

Study Overview
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Brief Summary
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The objective of this study was to compare the an adhesive latch device ( Dermaclip) to subcuticular skin closure at the time of cesarean section. Currently, no studies exist comparing these two closure techniques. The hypothesis is dermaclip closure is faster than subcuticular closure. The null hypothesis is there is no difference in closure times. There is a study (see reference at bottom) that compares staples closure to subcuticular closure, but none comparing subcuticular to dermaclip closure. Dermaclip device is easily deployed and is expected to be as fast as staples closure compared to subcuticular as noted in the prior study referenced below.

Official Title
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Comparison of Adhesive Latch Device to Subcuticular Skin Closure at the Time of Cesarean Section

Conditions
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Wound

Intervention / Treatment
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* Device: Dermaclip
* Device: Subcuticular suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 Elective cesarean section Term pregnancy Exclusion Criteria: Fever >101F in the past 14 days Antibiotics in the past 14 days Suspected ongoing infection Poorly controlled gestational diabetes Allergic to adhesive

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: A control group of subcuticular closure and the experimental group is skin closure withthe adhesive latch device (dermaclip)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subcuticular arm<br>closure technique that the Adhesive Latch arem (dermaclip) arm is being compared to | Device: Subcuticular suture<br>* subcuticular suture will be used as the device to close the skin in this arm<br>* Other names: sucuticular;|
| Active Comparator: Adhesive Latch Arm (Demaclip arm)<br>This is the arm which the adhesive latch system is used and it is being compared to the arm of subcuticular | Device: Dermaclip<br>* Dermaclip is an adhesive latch device used for skin closure<br>* Other names: adhesive latch device, dermaclip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of adhesive latch device to subcuticular skin closure at the time of cesarean section | The time for skin closure between subcuticular and demaclip techniques will compared during cesarean section | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Scores | - pain scores using the visual analog pain scale (VAPS) system | 18 months | 
| Wound Infections as measured in centimeters of erythema | - wound infections will measured in centimeters of redness/erythema around the infected area | 18 months | 
| Wound separation as measured in centimeters | - wound separation will be recorded centimeters | 18 months | 
| Patient Satisfaction scores | - patient satisfaction | 18 months | 
| Total surgery time | - total surgery time | 18 months | 
| Age | - age (years) | 18 months | 
| BMI | BMI of participants bmi (in kg/m2, weight in kg, height, in meters) | 18 months | 
| Ethnicity | Ethnic origin | 18 months | 
| Race | Race of participants | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dermaclip, subcuticular, cesarean section, staples, adhesive latch, rousseau