NCT01938586

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

April 15, 2016

Status Verified

September 1, 2013

Enrollment Period

7 months

First QC Date

September 5, 2013

Last Update Submit

April 14, 2016

Conditions

Keywords

ScarAppearance

Outcome Measures

Primary Outcomes (1)

  • Overall scar appearance as evaluated by the Patient and Observer Scar Assessment Scale

    6 months

Secondary Outcomes (2)

  • Rates of postoperative complications

    6 months

  • Time for closure of each split half portion of wound

    1 hour (intraoperative)

Study Arms (1)

Surgical excision

Other: Steri-StripOther: Superficial sutures

Interventions

Surgical excision
Surgical excision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Outpatient dermatology clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Dermatology Clinic

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cosmetic Dermatology, Vice-Chair of Operations

Study Record Dates

First Submitted

September 5, 2013

First Posted

September 10, 2013

Study Start

November 1, 2013

Primary Completion

June 1, 2014

Study Completion

August 1, 2014

Last Updated

April 15, 2016

Record last verified: 2013-09

Locations