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

Primary Purpose

Lacerations

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
suturing laceration
bioadhesive
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lacerations focused on measuring Hand, Laceration, bioadhesive, ER, Hand laceration distal to the volar wrist crease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hadassah Medical Organization

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

suturing lacerations of the hand

using bioadhesive on lacerations of hand

Outcomes

Primary Outcome Measures

Wound appearance

Secondary Outcome Measures

pain of treatment and time length of treatment

Full Information

First Posted
September 4, 2007
Last Updated
September 4, 2007
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00524888
Brief Title
Suturing vs Biological Adhesive in Simple Lacerations of Hand
Acronym
sutvsglu
Official Title
Suturing Vs Adhesion for Hand Lacerations in the ER A Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lacerations
Keywords
Hand, Laceration, bioadhesive, ER, Hand laceration distal to the volar wrist crease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
suturing lacerations of the hand
Arm Title
2
Arm Type
Active Comparator
Arm Description
using bioadhesive on lacerations of hand
Intervention Type
Procedure
Intervention Name(s)
suturing laceration
Intervention Description
suturing simple lacerations of the hand
Intervention Type
Procedure
Intervention Name(s)
bioadhesive
Intervention Description
using bioadhesive on simple lacerations of the hand
Primary Outcome Measure Information:
Title
Wound appearance
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
pain of treatment and time length of treatment
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Icekson, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
0097226776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg
Phone
00972256777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
MICHAEL ICEKSON, MD

12. IPD Sharing Statement

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Suturing vs Biological Adhesive in Simple Lacerations of Hand

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