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

Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03052647
• Other study ID #: Rubinoobgyn
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2017
• Last updated: February 13, 2017
• Start date: June 1, 2016
• Est. completion date: March 1, 2018

Study information

• Verified date: February 2017
• Source: Rubino Ob-Gyn Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: March 1, 2018
• Est. primary completion date: November 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound

Intervention

Device:
• Dermaclip
Dermaclip is an adhesive latch device used for skin closure
• Subcuticular suture
subcuticular suture will be used as the device to close the skin in this arm

Locations

Country	Name	City	State
United States	Rubino OBGYN Group	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rubino Ob-Gyn Group

Country where clinical trial is conducted

United States, 

Outcome

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