Closure Techniques and Scar Appearance

NCT ID: NCT01352533

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Wound Closure Techniques

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Running polypropylene closure

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

Group Type ACTIVE_COMPARATOR

Running polypropylene closure

Intervention Type PROCEDURE

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

Tissue Adhesive (Derma-Bond)

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

Group Type EXPERIMENTAL

Tissue Adhesive (Derma-Bond)

Intervention Type PROCEDURE

Approximately half of wounds will be randomized to be closed 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.

Group Type EXPERIMENTAL

Subcuticular polyglactin-910 combined with tissue adhesive

Intervention Type PROCEDURE

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

Interventions

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Running polypropylene closure

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

Intervention Type PROCEDURE

Tissue Adhesive (Derma-Bond)

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Murad Alam

Associate Professor of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Murad Alam, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Countries

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United States

Other Identifiers

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STU38040

Identifier Type: -

Identifier Source: org_study_id