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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2018-03-01

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.

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Detailed Description

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Conditions

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Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

computer randomized list of closure type opened from a sealed envelope on the day of surgery

Study Groups

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Subcuticular arm

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

Group Type ACTIVE_COMPARATOR

Subcuticular suture

Intervention Type DEVICE

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

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

Group Type ACTIVE_COMPARATOR

Dermaclip

Intervention Type DEVICE

Dermaclip is an adhesive latch device used for skin closure

Interventions

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Dermaclip

Dermaclip is an adhesive latch device used for skin closure

Intervention Type DEVICE

Subcuticular suture

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

Intervention Type DEVICE

Other Intervention Names

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adhesive latch device, dermaclip sucuticular

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes