Status:
TERMINATED
Post Approval Study to Evaluate the Safety and Performance of GENTA-FOIL Resorb® in Hand Surgery
Lead Sponsor:
Advanced Medical Solutions Ltd.
Collaborating Sponsors:
Newcastle-upon-Tyne Hospitals NHS Trust
KAT General Hospital
Conditions:
Tissue Adhesions, Surgery-Induced
Eligibility:
All Genders
18+ years
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 a...
Eligibility Criteria
Inclusion
- Subject is male or female, ≥18 years of age;
- Subject is willing and able to give written informed consent;
- Subject is scheduled for one if the following surgical procedures:
- 3a. extensor tendon repair zones I to VI.
- 3b. flexor tendon repair zones I to VI.
- 3c. open reduction and internal fixation to repair hand fractures of proximal phalanx, and/or middle phalanx, and/or metacarpals
- Subject is willing and able to comply with the study procedures during surgery and the post-surgical follow up period.
Exclusion
- Subject is known to be sensitive to any of the device components e.g. Gentamicin (aminoglycosides) or equine collagen.
- Subject is known to be non-compliant with medical treatment.
- Subject has any known impaired renal function/autoimmune illness/neuromuscular disease (such as Parkinson's or Myasthenia Gravis).
- Subject is currently taking an Aminoglycoside antibiotic as stand-alone treatment or in combination with other antibiotics
- Subject is pregnant or actively breastfeeding.
- Subject has active infection at surgical site
- Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with their ability to participate in the study, or affect the study outcomes.
- Subject is currently enrolled in another clinical study that would interfere with their ability to participate in this study
Key Trial Info
Start Date :
October 14 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 7 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04482140
Start Date
October 14 2024
End Date
November 7 2025
Last Update
November 19 2025
Active Locations (3)
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1
KAT Attica General Hospital
Athens, Athens, Greece, 14561
2
Whiston Hospital - Mersey and West Lancashire Teaching Hospitals Trust
Rainhill, Merseyside, United Kingdom, L35 5DR
3
Royal Victoria Infirmary Newcastle Upon Tyne NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP