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

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.

Study Overview

• Status: Unknown
• Conditions: Wound
• Intervention / Treatment: Device: Subcuticular suture; Device: Dermaclip

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • West Orange, New Jersey, United States, 07052
      • Recruiting
      • Rubino OBGYN Group
      • Contact: Robert J Rubino, MD; Phone Number: 973-736-1100; Email: rubinoobgyn@yahoo.com
      • Contact: Priya Patel, MD; Phone Number: 9737361100; Email: ppatel@rubinoobgyn.com
      • Principal Investigator: Robert J Rubino, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rubino Ob-Gyn Group

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Anticipated): November 30, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 9, 2017
• First Posted (Actual): February 14, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2017
• Last Update Submitted That Met QC Criteria: February 13, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: cesarean section; dermaclip; subcuticular; staples; adhesive latch; rousseau
• Other Study ID Numbers: Rubinoobgyn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No