Comparison of Traditional Superficial Cutaneous Sutures V... | NCT01938586

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

NCT01938586

Sponsor

Henry Ford Health System

Status

Completed

Last Update Posted

Apr 15, 2016Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Wound Cosmesis

Interventions

Steri-Strip
Superficial sutures

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Jun 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Sep 5, 2013

First Submission Date that Met QC Criteria

Sep 5, 2013

First Posted Date

Sep 10, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2016

Last Update Posted Date

Apr 15, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

David M. Ozog, Director of Cosmetic Dermatology, Vice-Chair of Operations, Henry Ford Health SystemPrincipal Investigator

Lead Sponsor

Henry Ford Health SystemOTHER

Collaborators

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
Surgical excision			Other: Steri-Strip Other: Superficial sutures

Name	Type	Description	Arm Group Labels	Other Names
Steri-Strip	Other		Surgical excision
Superficial sutures

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Outpatient dermatology clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henry Ford Dermatology Clinic		Detroit	Michigan	48202	United States

Condition Browse Module

MeSH Terms

ID	Term
D002921	Cicatrix

Ancestor Terms

ID	Term
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided