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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00524888
First Posted: September 5, 2007
Last Update Posted: September 5, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Suturing Vs Adhesion for Hand Lacerations in the ER A Randomized Prospective Study

Resource links provided by NLM:


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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00524888     History of Changes
Other Study ID Numbers: sutvsglu-HMO-CTIL
First Submitted: September 4, 2007
First Posted: September 5, 2007
Last Update Posted: September 5, 2007
Last Verified: August 2007

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

Additional relevant MeSH terms:
Lacerations
Wounds and Injuries