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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00524888
Other study ID # sutvsglu-HMO-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 4, 2007
Last updated September 4, 2007
Start date September 2007

Study information

Verified date August 2007
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
suturing laceration
suturing simple lacerations of the hand
bioadhesive
using bioadhesive on simple lacerations of the hand

Locations

Country Name City State
Israel Hadassah Medical Organization Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Wound appearance 3 Months
Secondary pain of treatment and time length of treatment 3 months
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Completed NCT00547638 - Study to Show Equivalence of DERMABOND PROTAPE to DERMABOND HVD for Wound Closure Phase 2
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Withdrawn NCT00933829 - Comparison of Cosmetic Outcomes of Lacerations Repaired Using Absorbable Versus Non-absorbable Sutures N/A
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