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

Launched by ADVANCED MEDICAL SOLUTIONS LTD. · Jul 20, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a product called Genta-Foil Resorb®, which is being tested for its ability to prevent tissue adhesions in patients undergoing certain hand surgeries. Tissue adhesions are when tissues stick together in ways they shouldn't, which can cause problems after surgery. The trial aims to ensure that this product is safe and works well for people who are having specific procedures, like repairing tendons or fixing hand fractures.

To participate in the study, individuals must be at least 18 years old and scheduled for one of the eligible surgeries. They should also be willing to follow the study procedures and provide consent to participate. However, some people cannot join, including those with certain allergies, medical conditions, or ongoing infections. Participants in the trial can expect to go through surgery with the Genta-Foil Resorb® used to help prevent adhesions, and they will be monitored during their recovery to see how well it works. Overall, this trial is an important step in improving hand surgery outcomes for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is male or female, ≥18 years of age;
• • 2. Subject is willing and able to give written informed consent;
• 3. 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
• • 4. Subject is willing and able to comply with the study procedures during surgery and the post-surgical follow up period.
• Exclusion Criteria:
• • 1. Subject is known to be sensitive to any of the device components e.g. Gentamicin (aminoglycosides) or equine collagen.
• • 2. Subject is known to be non-compliant with medical treatment.
• • 3. Subject has any known impaired renal function/autoimmune illness/neuromuscular disease (such as Parkinson's or Myasthenia Gravis).
• • 4. Subject is currently taking an Aminoglycoside antibiotic as stand-alone treatment or in combination with other antibiotics
• • 5. Subject is pregnant or actively breastfeeding.
• • 6. Subject has active infection at surgical site
• • 7. 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.
• • 8. Subject is currently enrolled in another clinical study that would interfere with their ability to participate in this study