Closure Techniques and Scar Appearance

Wound Closure Techniques Clinical Trial

Official title:

A Randomized Prospective Trial of 2-Octyl Cyanoacrylate (Derma-Bond) Tissue Adhesive Versus Running Subcuticular Suture Combined With Tissue Adhesive Versus Epidermal Sutures in Dermatologic Surgery Procedures of the Head and Neck

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01352533
• Other study ID #: STU38040
• Status: Withdrawn
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: December 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to assess whether wound closure with skin adhesive or running stitches combined with skin adhesive will be superior to standard wound sutures. This is a split-wound study that will compare two methods of skin closure within one standard closure technique, thereby providing an internal control of running stitches within each wound. The investigators plan to measure outcomes by assessing for scar appearance, the incidence of wound opening, scar elasticity and subject satisfaction.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and over

• Linear closures on the head and neck, at least 3cm in length

• The subjects are in good health

• The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

• Under 18 years of age

• Pregnancy or Lactation

• Subjects who are unable to understand the protocol or to give informed consent

• Subjects with mental illness

• Defects on the scalp

Related Conditions & MeSH terms

• Wound Closure Techniques

Intervention

Procedure:
• Running polypropylene closure
Half of every wound will be closed with Standard of Care running polypropylene sutures
• Tissue Adhesive (Derma-Bond)
Approximately half of wounds will be randomized to be closed with tissue adhesive.
• Subcuticular polyglactin-910 combined with tissue adhesive
Approximately half of the experimental wounds will be randomized to be closed with a combination of subcuticular polyglactin-910 and tissue adhesive.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound Healing	The primary outcome measure of this study will be wound healing. This outcome will be assessed by the blinded observers, subject ratings and Cutometer measurements of scar elasticity. Two double-blinded dermatologists will be asked to rate the scars according to the objective scar scales at the 10 day/ 3 week and 3 month follow-up exams.	10 day/3 weeks and 3 months
Secondary	Dehiscence	The rate of dehiscence observed will be noted and recorded by the treating physicians.	10 days/3 weeks and 3 months
Secondary	Subject Satisfaction	The subjects will fill out the VAS to evaluate their overall assessment of their scar, any associated pruritus and pain. The subjects will also fill out a Subject Satisfaction Survey to evaluate subject preference for closure.	10 days/3 weeks and 3 months
Secondary	Adverse Events	The treating physicians will note occurrence and extent of any adverse events associated with either type of epidermal closure.	10 days/3 weeks and 3 months