Evaluating GENTA-FOIL resorb® for preventing tissue adhesions 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
Advanced Medical Solutions Ltd. · NCT04482140
This study is testing if a special absorbable barrier can help prevent tissue sticking together after hand surgery, making it easier for patients to move their fingers again.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Advanced Medical Solutions Ltd. (industry) |
| Locations | 3 sites (Athens and 2 other locations) |
| Trial ID | NCT04482140 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and performance of GENTA-FOIL resorb®, an absorbable collagen barrier foil, in preventing tissue adhesions during the healing process after hand surgery. The study involves patients scheduled for specific surgical procedures, including tendon repairs and fracture fixations. By forming a temporary barrier between tissue layers, GENTA-FOIL resorb® seeks to enhance hand mobility and functional restoration post-surgery. The primary outcome will be measured by the restoration of digital function in subjects undergoing these procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for specific hand surgeries involving tendon repairs or fracture fixations.
Not a fit: Patients with known sensitivities to the device components or those with certain medical conditions, such as impaired renal function or neuromuscular diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes and quality of life for patients undergoing hand surgery by reducing the incidence of debilitating tissue adhesions.
How similar studies have performed: While the use of absorbable barriers in surgery is established, the specific application of GENTA-FOIL resorb® for preventing tissue adhesions in hand surgery is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Athens and 2 other locations
- KAT Attica General Hospital — Athens, Greece (NOT_YET_RECRUITING)
- Whiston Hospital - Mersey and West Lancashire Teaching Hospitals Trust — Rainhill, Merseyside, United Kingdom (RECRUITING)
- Royal Victoria Infirmary Newcastle Upon Tyne NHS Foundation Trust — Newcastle- Upon Tyne, Tyne and Wear, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Stephen Lipscombe — Whiston Hospital Mersey and West Lancashire Teaching Hospitals NHS Trust, Warrington Rd, Rainhill, Prescot
- Study coordinator: Susan Clark
- Email: susan.clark@admedsol.com
- Phone: 01606863500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tissue Adhesions, Surgery-Induced, Hand Mobility, Wound Healing, Functional restoration