Closure Techniques and Scar Appearance

Northwestern University

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Wound Closure Techniques

Interventions

Running polypropylene closurePROCEDURE

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

Tissue Adhesive (Derma-Bond)PROCEDURE

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

Subcuticular polyglactin-910 combined with tissue adhesivePROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 10 day/3 weeks and 3 months

Secondary Outcomes

Dehiscence

The rate of dehiscence observed will be noted and recorded by the treating physicians.

Time frame: 10 days/3 weeks and 3 months

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.

Time frame: 10 days/3 weeks and 3 months

Adverse Events

The treating physicians will note occurrence and extent of any adverse events associated with either type of epidermal closure.

Time frame: 10 days/3 weeks and 3 months

Data from ClinicalTrials.gov

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