Repairing a deep donor site using a new, dissolvable, plastic scaffold.

Not Applicable

Completed

• Conditions: Post harvest Free flap donor site appearance and function; Skin - Other skin conditions

• Registration Number: ACTRN12611000753954
• Lead Sponsor: ovoSkin Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-18
• Study Completion: 2016-02-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Ability to provide informed consent; requirement for free-flap surgery involving either anterolateral thigh flap or radial forearm flapfree

Exclusion Criteria

Pregnancy, severe debility precluding second anaesthetic; inability to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Appearance of the donor site compared to historical data. Assessment will be by clinical appearance (incorporation of the foam is visible and progressive to day 7 then consolidates), ease of delamination of the sealing membrane in historical comparison to Integra dermal regeneration template, Visitrak wound measurement to assess degree of contraction.[Weekly to 6 weeks, then monthly to 12 months]

Secondary Outcome Measures

Name	Time	Method
Function of the donor site compared to historical data. This will be assessed by clinical means (pinching, shearing mobility, visibilty or otherwise of deeper structures (eg tendons in free radial forearm flap donor sites).[Weekly to 6 weeks, then monthly to 12 months]