NCT00524888

Brief Summary

To assess the difference in clinical outcome between lacerations in the hand treated by sutures versus treated by tissue adhesive.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 5, 2007

Completed
Last Updated

September 5, 2007

Status Verified

August 1, 2007

First QC Date

September 4, 2007

Last Update Submit

September 4, 2007

Conditions

Lacerations

Keywords

HandLacerationbioadhesiveERHand laceration distal to the volar wrist crease

Outcome Measures

Primary Outcomes (1)

  • Wound appearance

    3 Months

Secondary Outcomes (1)

  • pain of treatment and time length of treatment

    3 months

Study Arms (2)

1

ACTIVE COMPARATOR

suturing lacerations of the hand

Procedure: suturing laceration

2

ACTIVE COMPARATOR

using bioadhesive on lacerations of hand

Procedure: bioadhesive

Interventions

suturing lacerationPROCEDURE

suturing simple lacerations of the hand

1
bioadhesivePROCEDURE

using bioadhesive on simple lacerations of the hand

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any age
  • Hand laceration distal to the volar wrist crease.

You may not qualify if:

  • Fracture , tendon, artery involvement, more than 8 hours from laceration to trx,
  • Immunosuppression
  • Anticoagulation therapy
  • Diabetes
  • Unable to achieve homeostasis in more than 15 minutes
  • Unwilling to participate in the study
  • Unable to participate in the follow up or bite of any kind.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Lacerations

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Michael Icekson, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 5, 2007

Study Start

September 1, 2007

Last Updated

September 5, 2007

Record last verified: 2007-08

Locations

IL(1)