Suturing vs Biological Adhesive in Simple Lacerations of... | NCT00524888

Studies
Suturing vs Biological Adhesive in Simple Lacerations of Hand

NCT00524888

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Sep 5, 2007Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Lacerations

Interventions

suturing laceration
bioadhesive

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 4, 2007

First Submission Date that Met QC Criteria

Sep 4, 2007

First Posted Date

Sep 5, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2007

Last Update Posted Date

Sep 5, 2007Estimated

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	suturing lacerations of the hand	Procedure: suturing laceration
2	Active Comparator	using bioadhesive on lacerations of hand	Procedure: bioadhesive

Interventions

Name	Type	Description	Arm Group Labels	Other Names
suturing laceration	Procedure	suturing simple lacerations of the hand	1

Measure	Description	Time Frame
Wound appearance		3 Months

Measure	Description	Time Frame
pain of treatment and time length of treatment		3 months

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Icekson, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization		Jerusalem		91120	Israel