NCT00681070

Brief Summary

Our research hypothesis in this study is that there is no difference in long-term cosmetic outcomes between absorbable sutures and non-absorbable sutures in the repair of pediatric facial lacerations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

May 19, 2008

Last Update Submit

February 8, 2017

Conditions

LacerationsWounds

Keywords

lacerationwound managementabsorbable suturescosmetic outcomes

Outcome Measures

Primary Outcomes (1)

  • cosmetic outcomes

    3 months

Secondary Outcomes (1)

  • infection

    4-6 days

Study Arms (2)

Arm1: Non-absorbable sutures

ACTIVE COMPARATOR

use of non-absorbable sutures in facial laceration in this arm

Other: Arm 1: non-absorbable sutures

Arm 2: Absorbable sutures

ACTIVE COMPARATOR

use of absorbable sutures in this arm

Other: Arm 2: Absorbable sutures

Interventions

Arm 2: Absorbable suturesOTHER

use of absorbable catgut sutures in pediatric facial lacerations

Also known as: fast-absorbing catgut 5-0 by Johnson and Johnson
Arm 2: Absorbable sutures
Arm 1: non-absorbable suturesOTHER

Use of non-absorbing sutures

Arm1: Non-absorbable sutures

Eligibility Criteria

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

You may qualify if:

  • Clean. minimally contaminated facial lacerations, between 1-5 cms long, less than 8 hours old, not caused by animal bites, not needing plastic surgery repair

You may not qualify if:

  • Pregnancy
  • Bleeding
  • Renal
  • Endocrine problems
  • Dirty wounds
  • Irregular wounds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19130, United States

Location

MeSH Terms

Conditions

LacerationsWounds and Injuries

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

May 19, 2008

First Posted

May 21, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2010

Study Completion

September 1, 2010

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

US(2)