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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Tissue Adhesions, Surgery-Induced
• Intervention / Treatment: Device: Genta-Foil resorb®

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.

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Susan Clark; Phone Number: 01606863500; Email: susan.clark@admedsol.com
• Study Contact Backup: Name: Hajnal Zdravics; Phone Number: 01606863500; Email: hajnal.zdravics@admedsol.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Genta-Foil resorb®; 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.

Device: Genta-Foil resorb®; Use of Genta-Foil resorb® to prevent adhesions in patients undergoing hand surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restoration of hand mobility	Restoration of hand mobility will be assessed using functional assessment scoring Total Active Motion (TAM) at 90 days post-surgery. This will be measured by the modified Strickland scoring criteria. The success criteria is defined as TAM score of 75% or above at 90 days post-surgery. Restriction of TAM post-surgery is indicative of tissue adhesions, therefore this measure will demonstrate presence / absence of of tissue adhesions.	At 90 days post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of device related infections at surgical site up to 30 days post-surgery.	As per local Standard of Care wound assessment, absence or presence of wound signs infection will be recorded.	Up to 30 days post-surgery
Incidence of device related adverse events	Evaluation of safety of GENTA-FOIL resorb® by recording of any device or procedure-related adverse events throughout the surgery during the follow-up period (day of surgery, at 7 days, 14 days, 30 days and 90 days post-surgery)	Up to 90 days post-surgery
Subjective assessment of symptoms and abilities to perform activities by 90 days post-surgery	Study subjects requested to self assess symptoms and abilities to perform activities by 90 days post-surgery. Subjects will be asked to complete the standardised QuickDASH upper extremity outcome measure questionnaire. QuickDASH Outcome Measure tool measures the individual's ability to complete tasks at home and severity of symptoms. The tool uses 11 questions and a 5-point Likert Scale from which the patient can select an appropriate number corresponding to their severity / function level.	At 90 days post-surgery
Wound healing without complications up to 30 days post-surgery.	Standard of Care wound assessments will be performed at follow-up visits at day 7, day 14 and day 30 as appropriate, by a designated member of the Hand Dressing Clinic as per local Outpatient Wound Assessment Tool. As part of wound assessment, date of when wound is healed will be recorded during appropriate follow-up visit.	Up to 30 days
Change in patient pain scores (assessed using VAS) up to 90 days post-surgery.	Severity of localised pain in the affected hand or finger(s) will be measured using a Visual Analogue Scale (VAS). The VAS will be a 10cm horizontal line, with descriptors at each end [no pain (0cm), and worst imaginable pain (10cm)]. Subjects will be asked to place a mark on the scale that corresponds to their pain. The distance from the lower end of the scale will be measured and recorded.	Up to 90 days post-surgery
Clinicians' satisfaction with the device at time of surgery	Assessment of satisfaction with device conformability and ease of use. Assessed using a Likert-type scale.	Immediately post-surgery

Collaborators and Investigators

• Sponsor: Advanced Medical Solutions Ltd.
• Investigators: Principal Investigator: Stephen Lipscombe, Whiston Hospital Mersey and West Lancashire Teaching Hospitals NHS Trust, Warrington Rd, Rainhill, Prescot

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 22, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Hand Mobility, Wound Healing, Functional restoration
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: 001GF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No