Clinical trial NCT04482140: Post Approval Study to Evaluate the Safety and Performance of GENTA-FOIL Resorb® in Hand Surgery
Official title: Post Approval Study to Evaluate the Safety and Performance of GENTA-FOIL Resorb® for the Prevention of Tissue Adhesions in Hand Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tissue Adhesions, Surgery-Induced
Keywords: Hand Mobility, Wound Healing, Functional restoration
Lead sponsor: Advanced Medical Solutions Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Newcastle-upon-Tyne Hospitals NHS Trust
name: KAT General Hospital
First posted: 2020-07-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who are undergoing hand surgery with the Genta-Foil resorb® device, and who meet all inclusion criteria and none of the exclusion criteria

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 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.

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

Primary outcomes:
measure: Restoration of hand mobility
timeFrame: At 90 days post-surgery
Secondary outcomes:
measure: Incidence of device related infections at surgical site up to 30 days post-surgery.
timeFrame: Up to 30 days post-surgery
measure: Incidence of device related adverse events
timeFrame: Up to 90 days post-surgery
measure: Subjective assessment of symptoms and abilities to perform activities by 90 days post-surgery
timeFrame: At 90 days post-surgery
measure: Wound healing without complications up to 30 days post-surgery.
timeFrame: Up to 30 days
measure: Change in patient pain scores (assessed using VAS) up to 90 days post-surgery.
timeFrame: Up to 90 days post-surgery
measure: Clinicians' satisfaction with the device at time of surgery
timeFrame: Immediately post-surgery
Other outcomes:
Locations:
city: Athens
country: Greece
facility: KAT Attica General Hospital
city: Rainhill
country: United Kingdom
facility: Whiston Hospital - Mersey and West Lancashire Teaching Hospitals Trust
state: Merseyside
city: Newcastle- Upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary Newcastle Upon Tyne NHS Foundation Trust
state: Tyne and Wear
Study officials:
affiliation: Whiston Hospital Mersey and West Lancashire Teaching Hospitals NHS Trust, Warrington Rd, Rainhill, Prescot
name: Stephen Lipscombe
role: PRINCIPAL_INVESTIGATOR
References: