Comparison of Cosmetic Outcomes of Lacerations Repaired U... | NCT00933829

Studies
Comparison of Cosmetic Outcomes of Lacerations Repaired Using Absorbable Versus Non-absorbable Sutures

NCT00933829

Sponsor

Temple University

Status

Withdrawn

Last Update Posted

Jun 4, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Lacerations
Wounds
Injuries

Interventions

Absorbable Suture Arm
Non-absorbable suture (Prolene)
suture

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Jul 2, 2009

First Submission Date that Met QC Criteria

Jul 6, 2009

First Posted Date

Jul 7, 2009Estimated

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

Jun 2, 2020

Last Update Posted Date

Jun 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary objective of this prospective, randomized study is to compare cosmetic outcomes between absorbable and non-absorbable sutures in truncal and extremity lacerations in the pediatric and adult population. Secondary outcome measures include wound complications such as infection and wound dehiscence at the initial visit; and parental satisfaction and keloid formation after three months post repair.

Detailed Description

Even though there some studies showing good outcomes using absorbable sutures in skin closure in clean surgical wounds, ED based studies still need to be conducted to convince ED physicians that the use of absorbable sutures to close the skin in traumatic lacerations are just as acceptable as traditional non-absorbable sutures. Use of absorbable sutures confers several advantages over non-absorbable sutures. For one, patients do not need an additional physician visit either in the office, or more often that not, in the emergency department. These visits add to ED overcrowding, prolonged length of ED stay and are often not reimbursed if seen in the emergency department. Moreover, adult patients need to miss work or school and children often have to miss school or daycare to have these sutures removed. The potential to avert another traumatic experience from suture removal in children who had been restrained for suture placement is another advantage of using absorbable sutures over non-absorbable sutures.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-absorbable arm	Placebo Comparator	uses non-absorbable suture such as Prolene to repair lacerations	Device: Non-absorbable suture (Prolene) Procedure: suture
Absorbable Suture Arm	Active Comparator	uses absorbable sutures to repair lacerations	Procedure: Absorbable Suture Arm Procedure: suture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Absorbable Suture Arm	Procedure	use of irradiated polyglactin 910	Absorbable Suture Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale.		at least 3 months post-injury

Secondary Outcomes

Measure	Description	Time Frame
Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury.		8-12 days post-injury

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Isolated injury
Non-contaminated or minimally contaminated wounds
Linear laceration 1-5 cms
Topical adhesives not indicated

Exclusion Criteria:

Trunk and extremity lacerations less than 1 cm or greater than 5 cm.
Moderately contaminated wounds or dirty wounds
Wounds with visible foreign bodies
Wounds more than 8 hours old
Wounds that can be repaired using topical adhesives
Complex wounds needing surgical referral
Wounds caused by mammalian bites
Wounds in patients with immune deficiency, pregnancy, diabetes, suspected bleeding disorder or renal dysfunction
Wounds in patients who are currently taking steroids
Wounds in areas of tension such as the joint or crease
Patients with allergic reaction to the topical anesthetic
Irregular wounds

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raemma p Luck, MD	Temple University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Temple University Hospital		Philadelphia	Pennsylvania	19140	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15620501	Result	Al-Qattan MM. Vicryl Rapide versus Vicryl suture in skin closure of the hand in children: a randomized prospective study. J Hand Surg Br. 2005 Feb;30(1):90-1. doi: 10.1016/j.jhsb.2004.08.005.
25039547	Derived	Tejani C, Sivitz AB, Rosen MD, Nakanishi AK, Flood RG, Clott MA, Saccone PG, Luck RP. A comparison of cosmetic outcomes of lacerations on the extremities and trunk using absorbable versus nonabsorbable sutures. Acad Emerg Med. 2014 Jun;21(6):637-43. doi: 10.1111/acem.12387.

ID	Term
D022125	Lacerations
D014947	Wounds and Injuries

ID	Term
D053831	Surgical Fixation Devices
D013523	Surgical Equipment
D004864	Equipment and Supplies