Closure Techniques and Scar Appearance

Not Applicable

Withdrawn

• Conditions: Wound Closure Techniques
• Interventions: Procedure: Subcuticular polyglactin-910 combined with tissue adhesive; Procedure: Tissue Adhesive (Derma-Bond); Procedure: Running polypropylene closure

• Registration Number: NCT01352533
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-12
• Study Start: 2016-07
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subcuticular polyglactin-910 combined with tissue adhesive	Subcuticular polyglactin-910 combined with tissue adhesive	The experimental half of the wound will be randomized to receive closure with running subcuticular polyglactin-910 combined with tissue adhesive.
Tissue Adhesive (Derma-Bond)	Tissue Adhesive (Derma-Bond)	The experimental half of the wound will be randomized to receive closure with tissue adhesive alone.
Running polypropylene closure	Running polypropylene closure	Half of every linear wound will be closed with running polypropylene sutures. This technique is Standard of Care.

Primary Outcome Measures

Name	Time	Method
Wound Healing	10 day/3 weeks and 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Dehiscence	10 days/3 weeks and 3 months	The rate of dehiscence observed will be noted and recorded by the treating physicians.
Adverse Events	10 days/3 weeks and 3 months	The treating physicians will note occurrence and extent of any adverse events associated with either type of epidermal closure.
Subject Satisfaction	10 days/3 weeks and 3 months	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.