Optimal Suture Choice for Improved Scar Outcomes

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-07-31

Brief Summary

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Certain parts of the body, such as the chest, back, and shoulders, are notorious for producing cosmetically poor scars after cutaneous surgery. While very little research has been done to understand these poor outcomes, it is generally thought that increased tension across the skin inherent to these body areas leads to significant widening of the final scar. Historically, the only way to combat this tension was to support the deeper portion of the wound with sutures that dissolve over several weeks. However, scars take many months to fully develop their greatest strength. So even with the standard technique, wounds in areas of high tension still show spreading of the scar with time. The investigators believe that these wounds require an extended duration of support throughout the scar's maturation period. Until recently, there did not exist a suture that could provide this long duration of support without also carrying the risk of the body rejecting it. Recently, a new extremely long acting absorbable biomaterial has been FDA approved for use as a suture. The investigators plan to use this suture to test the theory that alleviating stress on high tension wounds throughout the period which they gain their maximal integrity produces less scar spread and ultimately better cosmetic outcomes.

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Detailed Description

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Conditions

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Cicatrix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Tepha

Group Type EXPERIMENTAL

Intradermal Suture

Intervention Type PROCEDURE

Vicryl

Group Type ACTIVE_COMPARATOR

Intradermal Suture

Intervention Type PROCEDURE

Interventions

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Intradermal Suture

Intervention Type PROCEDURE

Intradermal Suture

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients requiring excision of a lesion on chest, back, or shoulders

Exclusion Criteria

* History of ionizing radiation
* History of keloid or hypertrophic scarring
* History of or current internal malignancy
* History of bleeding disorder
* History of collagen or elastin disorder
* Current use of immunosuppressive medications

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No