NCT04482140

Post Approval Study to Evaluate the Safety and Performance of GENTA-FOIL Resorb® in Hand Surgery

Post Approval Study to Evaluate the Safety and Performance of GENTA-FOIL Resorb® for the Prevention of Tissue Adhesions in Hand Surgery

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Advanced Medical Solutions Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 subject's 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 (e.g. 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.

Conditions

• Tissue Adhesions, Surgery-Induced

Interventions

Type	Name	Description
DEVICE	Genta-Foil resorb®	Use of Genta-Foil resorb® to prevent adhesions in patients undergoing hand surgery

Timeline

• Start date: 2024-10-14
• Primary completion: 2025-11-07
• Completion: 2025-11-07
• First posted: 2020-07-22
• Last updated: 2025-11-19

Locations

3 sites across 2 countries: Greece, United Kingdom