Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04482140
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2020-07-15
Brief Title:
Post Approval Study to Evaluate the Safety and Performance of GENTA-FOIL Resorb in Hand Surgery
Sponsor:
Advanced Medical Solutions Ltd
Organization:
Advanced Medical Solutions Ltd
Study Overview
Official Title:
Post Approval Study to Evaluate the Safety and Performance of GENTA-FOIL Resorb for the Prevention of Tissue Adhesions in Hand Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Single arm study to evaluate the safety and performance of Genta-Foil resorb for the prevention of tissue adhesions
Detailed Description:
GENTA-FOIL resorb is an implantable absorbable collagen barrier foil which forms a temporary barrier between the functional structures during the critical phase of wound healing As a result the ability of the tissue layers to slide against each other is retained
The objective of hand surgery is to promote wound repair and regeneration of all motor and sensory functions of the hand and to restore the subjects hand mobility and improve their quality of life However hand trauma and operations often lead to the formation of adhesions between the various tissue layers of the hand eg muscles tendons and nerves Even with minimally invasive procedures and optimal aftercare development of adhesions in the suture and wound areas is often unavoidable Adhesion formation between repaired tendons and the surrounding tissue has been thought to be one of the most important factors that disturbs functional restoration It is estimated that the adhesion which can cause significant disability occurs in about 30 of cases
The purpose of this study is to investigate the use of GENTA-FOIL resorb for the prevention of tissue adhesions measured by restoration in digital function in subjects undergoing hand surgery The functional outcome of tendon injury after a repair depends on multiple factors such as age injury level and type type of repair and post repair therapy
The objective of hand surgery is to promote wound repair and regeneration of all motor and sensory functions of the hand and to restore the subjects hand mobility and improve their quality of life However hand trauma and operations often lead to the formation of adhesions between the various tissue layers of the hand eg muscles tendons and nerves Even with minimally invasive procedures and optimal aftercare development of adhesions in the suture and wound areas is often unavoidable Adhesion formation between repaired tendons and the surrounding tissue has been thought to be one of the most important factors that disturbs functional restoration It is estimated that the adhesion which can cause significant disability occurs in about 30 of cases
The purpose of this study is to investigate the use of GENTA-FOIL resorb for the prevention of tissue adhesions measured by restoration in digital function in subjects undergoing hand surgery The functional outcome of tendon injury after a repair depends on multiple factors such as age injury level and type type of repair and post repair therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None