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

Comparison of Traditional Superficial Cutaneous Sutures Versus Steri-Strip Coaptive Film in Layered Dermatologic Closures on the Back - a Prospective, Randomized, Split-scar Study

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

Study Overview

• Status: Completed
• Conditions: Wound Cosmesis
• Intervention / Treatment: Other: Steri-Strip; Other: Superficial sutures

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Dermatology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Outpatient dermatology clinic

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall scar appearance as evaluated by the Patient and Observer Scar Assessment Scale	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of postoperative complications	Assessment of scar erythema, swelling, infection, drainage, dehiscence	6 months
Time for closure of each split half portion of wound		1 hour (intraoperative)

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: September 5, 2013
• First Submitted That Met QC Criteria: September 5, 2013
• First Posted (Estimate): September 10, 2013

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 14, 2016
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Scar; Appearance
• Other Study ID Numbers: SYDO-2013