NCT01069614

Brief Summary

A skin stretching device has been designed to stretch tissue prior to surgery, during surgery and in order to secure wounds following surgery. The device may be used in non-invasive and invasive applications.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
Last Updated

February 17, 2010

Status Verified

February 1, 2010

First QC Date

February 7, 2010

Last Update Submit

February 16, 2010

Conditions

Keywords

Equipment and supplies

Outcome Measures

Primary Outcomes (1)

  • Safety and efficacy of wound closure

Study Arms (1)

Skin stretching device

EXPERIMENTAL

Skin stretching device

Device: TopClosure 3S System

Interventions

Skin stretching device

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hard to close wounds

You may not qualify if:

  • Non-cooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 7, 2010

First Posted

February 17, 2010

Last Updated

February 17, 2010

Record last verified: 2010-02

Locations