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Comparison of Traditional Superficial Cutaneous Sutures Versus Steri-Strip Coaptive Film in Layered Dermatologic Closures

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ClinicalTrials.gov Identifier: NCT01938586
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
David M. Ozog, Henry Ford Health System

Brief Summary:
The purpose of this study is to compare the cosmetic outcome between buried intradermal and superficial cutaneous suture closures versus buried intradermal sutureand superficial Steri-Strip closures in the bilayered repair of dermatologic wounds on the back following elliptical excision of benign or malignant lesions

Condition or disease Intervention/treatment
Wound Cosmesis Other: Steri-Strip Other: Superficial sutures

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Traditional Superficial Cutaneous Sutures Versus Steri-Strip Coaptive Film in Layered Dermatologic Closures on the Back - a Prospective, Randomized, Split-scar Study
Study Start Date : November 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Group/Cohort Intervention/treatment
Surgical excision Other: Steri-Strip
Other: Superficial sutures



Primary Outcome Measures :
  1. Overall scar appearance as evaluated by the Patient and Observer Scar Assessment Scale [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Rates of postoperative complications [ Time Frame: 6 months ]
    Assessment of scar erythema, swelling, infection, drainage, dehiscence

  2. Time for closure of each split half portion of wound [ Time Frame: 1 hour (intraoperative) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Outpatient dermatology clinic
Criteria

Inclusion Criteria:

  • 18 years or greater in age
  • Simple excision of benign or malignant lesion on the back
  • Final scar length of at least 3cm

Exclusion Criteria:

  • Known history of keloid formation or hypertrophic scars
  • Known adhesive allergy
  • Pregnancy or active breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938586


Locations
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United States, Michigan
Henry Ford Dermatology Clinic
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System

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Responsible Party: David M. Ozog, Director of Cosmetic Dermatology, Vice-Chair of Operations, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01938586     History of Changes
Other Study ID Numbers: SYDO-2013
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: September 2013

Keywords provided by David M. Ozog, Henry Ford Health System:
Scar
Appearance