NCT00933829

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

1.4 years

First QC Date

July 2, 2009

Last Update Submit

June 2, 2020

Conditions

LacerationsWoundsInjuries

Keywords

absorbable suturesnon-absorbable sutureswound management

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is cosmetic outcomes at 3 to 4 months using the visual analogue scale.

    at least 3 months post-injury

Secondary Outcomes (1)

  • Secondary outcome measures: complication rates such as infection and dehiscence rates at the first visit post-injury.

    8-12 days post-injury

Study Arms (2)

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 ArmProcedure: suture

Interventions

Absorbable Suture ArmPROCEDURE

use of irradiated polyglactin 910

Also known as: Vicryl Rapide
Absorbable Suture Arm
Non-absorbable suture (Prolene)DEVICE

suture

Non-absorbable arm
suturePROCEDURE

non-absorable sutures and absorable sutures

Absorbable Suture ArmNon-absorbable arm

Eligibility Criteria

Age1 Year - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (2)

  • 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.

    PMID: 15620501RESULT

  • 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.

    PMID: 25039547DERIVED

Related Links

MeSH Terms

Conditions

LacerationsWounds and Injuries

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation DevicesSurgical EquipmentEquipment and Supplies

Study Officials

  • Raemma p Luck, MD

    Temple University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 7, 2009

Study Start

April 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

June 4, 2020

Record last verified: 2020-06

Locations

US(1)