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

NCT03052647 | Unknown FDA Device

• 1 other identifier: Rubinoobgyn
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound

Keywords

dermaclip; subcuticular; cesarean section; staples; adhesive latch; rousseau

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pain Scores

  18 months

• Wound Infections as measured in centimeters of erythema

  18 months

• Wound separation as measured in centimeters

  18 months

• Patient Satisfaction scores

  18 months

• Total surgery time

  18 months

Study Arms (2)

Subcuticular arm

ACTIVE COMPARATOR

closure technique that the Adhesive Latch arem (dermaclip) arm is being compared to

Device: Subcuticular suture

Adhesive Latch Arm (Demaclip arm)

ACTIVE COMPARATOR

This is the arm which the adhesive latch system is used and it is being compared to the arm of subcuticular

Device: Dermaclip

Interventions

Dermaclip DEVICE

Dermaclip is an adhesive latch device used for skin closure

Also known as: adhesive latch device, dermaclip

Adhesive Latch Arm (Demaclip arm)

Subcuticular suture DEVICE

subcuticular suture will be used as the device to close the skin in this arm

Also known as: sucuticular

Subcuticular arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age greater than 18
• Elective cesarean section
• Term pregnancy

You may not qualify if:

• Fever \>101F in the past 14 days
• Antibiotics in the past 14 days
• Suspected ongoing infection
• Poorly controlled gestational diabetes
• Allergic to adhesive

Sponsors & Collaborators

• Rubino Ob-Gyn Group: lead

Study Sites (1)

Rubino OBGYN Group

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: computer randomized list of closure type opened from a sealed envelope on the day of surgery
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator , Assistant Clinical Professor

Model Details: A control group of subcuticular closure and the experimental group is skin closure withthe adhesive latch device ("dermaclip")

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 14, 2017
• Study Start: June 1, 2016
• Primary Completion: November 30, 2017
• Study Completion: March 1, 2018
• Last Updated: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)