Closure Techniques and Scar Appearance

NCT01352533 | Withdrawn DMC

• 1 other identifier: STU38040
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Wound Closure Techniques

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Dehiscence

  10 days/3 weeks and 3 months

• Subject Satisfaction

  10 days/3 weeks and 3 months

• Adverse Events

  10 days/3 weeks and 3 months

Study Arms (3)

Running polypropylene closure

ACTIVE COMPARATOR

Half of every linear wound will be closed with running polypropylene sutures. This technique is Standard of Care.

Procedure: Running polypropylene closure

Tissue Adhesive (Derma-Bond)

EXPERIMENTAL

The experimental half of the wound will be randomized to receive closure with tissue adhesive alone.

Procedure: Tissue Adhesive (Derma-Bond)

Subcuticular polyglactin-910 combined with tissue adhesive

EXPERIMENTAL

The experimental half of the wound will be randomized to receive closure with running subcuticular polyglactin-910 combined with tissue adhesive.

Procedure: Subcuticular polyglactin-910 combined with tissue adhesive

Interventions

Running polypropylene closure PROCEDURE

Half of every wound will be closed with Standard of Care running polypropylene sutures

Running polypropylene closure

Tissue Adhesive (Derma-Bond) PROCEDURE

Approximately half of wounds will be randomized to be closed with tissue adhesive.

Tissue Adhesive (Derma-Bond)

Subcuticular polyglactin-910 combined with tissue adhesive PROCEDURE

Approximately half of the experimental wounds will be randomized to be closed with a combination of subcuticular polyglactin-910 and tissue adhesive.

Subcuticular polyglactin-910 combined with tissue adhesive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

MeSH Terms

Interventions

Tissue Adhesives

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Murad Alam, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Dermatology

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 12, 2011
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 6, 2021

Record last verified: 2021-12