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

Advanced Medical Solutions

Status: Enrolling

Conditions: Tissue Adhesions, Surgery-Induced

Treatments: Device: Genta-Foil resorb®

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04482140

001GF

Details and patient eligibility

About

Single arm study to evaluate the safety and performance of Genta-Foil resorb® for the prevention of tissue adhesions

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

55 participants in 1 patient group

Genta-Foil resorb®

Description:

Genta-Foil resorb® is a transparent collagen foil that 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 absorbability of equine collagen means the foil can be left in place and does not require removal. The addition of the antibiotic Gentamicin is for self-protection since collagen implants are prone to bacterial contamination.

Treatment:

Device: Genta-Foil resorb®