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

Not Applicable

• Conditions: Wound

• Registration Number: NCT03052647
• Lead Sponsor: Rubino Ob-Gyn Group

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-09
• Last Update Submitted: 2017-02-13
• Study First Posted: 2017-02-14
• Last Update Posted: 2017-02-15
• Primary Completion: 2017-11-30
• Study Completion: 2018-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

1. Age greater than 18
2. Elective cesarean section
3. Term pregnancy

Exclusion Criteria

1. Fever >101F in the past 14 days
2. Antibiotics in the past 14 days
3. Suspected ongoing infection
4. Poorly controlled gestational diabetes
5. Allergic to adhesive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of adhesive latch device to subcuticular skin closure at the time of cesarean section	18 months	The time for skin closure between subcuticular and demaclip techniques will compared during cesarean section

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rubino OBGYN Group; 🇺🇸 West Orange, New Jersey, United States