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Optimal Suture Choice for Improved Scar Outcomes

D

Dallas VA Medical Center

Status

Unknown

Conditions

Cicatrix

Treatments

Procedure: Intradermal Suture

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00938691
ASDS-45322

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

25 participants in 2 patient groups

Tepha
Experimental group
Treatment:
Procedure: Intradermal Suture
Procedure: Intradermal Suture
Vicryl
Active Comparator group
Treatment:
Procedure: Intradermal Suture
Procedure: Intradermal Suture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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