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

Rubino Ob-Gyn Group

Status: Unknown

Conditions: Wound

Treatments: Device: Dermaclip; Device: Subcuticular suture

Study type: Interventional

Funder types: Other

Identifiers

NCT03052647

Rubinoobgyn

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Subcuticular arm

Active Comparator group

Description:

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

Treatment:

Device: Subcuticular suture

Adhesive Latch Arm (Demaclip arm)

Active Comparator group

Description:

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

Treatment:

Device: Dermaclip