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Suturing vs Biological Adhesive in Simple Lacerations of Hand (sutvsglu)

This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, August 2007

Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00524888
  Purpose

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


Condition Intervention
Lacerations
Procedure: suturing laceration
Procedure: bioadhesive

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:   Suturing Vs Adhesion for Hand Lacerations in the ER A Randomized Prospective Study

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Wound appearance [ Time Frame: 3 Months ]

Secondary Outcome Measures:
  • pain of treatment and time length of treatment [ Time Frame: 3 months ]

Estimated Enrollment:   200
Study Start Date:   September 2007

Arms Assigned Interventions
1: Active Comparator
suturing lacerations of the hand
Procedure: suturing laceration
suturing simple lacerations of the hand
2: Active Comparator
using bioadhesive on lacerations of hand
Procedure: bioadhesive
using bioadhesive on simple lacerations of the hand

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524888

Locations
Israel
Hadassah Medical Organization     Not yet recruiting
      Jerusalem, Israel, 91120
      Contact: Arik Tzukert, DMD     0097226776095     arik@hadassah.org.il    
      Contact: Hadas Lemberg     00972256777572     lhadas@hadassah.org.il    
      Principal Investigator: MICHAEL ICEKSON, MD            

Sponsors and Collaborators
Hadassah Medical Organization

Investigators
Principal Investigator:     Michael Icekson, MD     Hadassah Medical Organization    
  More Information

Study ID Numbers:   sutvsglu-HMO-CTIL
First Received:   September 4, 2007
Last Updated:   September 4, 2007
ClinicalTrials.gov Identifier:   NCT00524888
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
Hand  
Laceration  
bioadhesive  
ER  
Hand laceration distal to the volar wrist crease  

Study placed in the following topic categories:
Lacerations
Wounds and Injuries
Disorders of Environmental Origin
Adhesions

ClinicalTrials.gov processed this record on September 05, 2008




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