Tissue Adhesions, Surgery-InducedNCT04482140
Post Approval Study to Evaluate the Safety and Performance of GENTA-FOIL Resorb® in Hand Surgery
An observational study of Tissue Adhesions, Surgery-Induced, run by Advanced Medical Solutions Ltd. at 3 sites in 2 countries.
Trial summary
Single arm study to evaluate the safety and performance of Genta-Foil resorb® for the prevention of tissue adhesions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tissue Adhesions, Surgery-Induced
- What is being tested?
- Genta-Foil resorb®
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 14 Oct 2024to 7 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Subject is male or female, ≥18 years of age;
- Subject is willing and able to give written informed consent;
- 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
- Subject is willing and able to comply with the study procedures during surgery and the post-surgical follow up period.
Who cannot join
- Subject is known to be sensitive to any of the device components e.g. Gentamicin (aminoglycosides) or equine collagen.
- Subject is known to be non-compliant with medical treatment.
- Subject has any known impaired renal function/autoimmune illness/neuromuscular disease (such as Parkinson's or Myasthenia Gravis).
- Subject is currently taking an Aminoglycoside antibiotic as stand-alone treatment or in combination with other antibiotics
- Subject is pregnant or actively breastfeeding.
- Subject has active infection at surgical site
- 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.
- Subject is currently enrolled in another clinical study that would interfere with their ability to participate in this study
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United Kingdom2 sites
Royal Victoria Infirmary Newcastle Upon Tyne NHS Foundation Trust
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
Whiston Hospital - Mersey and West Lancashire Teaching Hospitals Trust
Rainhill, Merseyside, L35 5DR
About this study
Official title: 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
Read the 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.
- Conditions
- Tissue Adhesions, Surgery-Induced
- Being tested
- Genta-Foil resorb®
- Keywords
- Hand Mobility, Wound Healing, Functional restoration
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genta-Foil resorb®Device
Use of Genta-Foil resorb® to prevent adhesions in patients undergoing hand surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Genta-Foil resorb® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 90 days post-surgery
Secondary outcomes (6)
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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start14 Oct 2024
- Primary completion7 Nov 2025
- Study completion7 Nov 2025
Why it stopped: slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue Adhesions, Surgery-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Medical Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, KAT General Hospital
- Responsible party
- Sponsor
- Investigators
- Stephen Lipscombe, Principal investigator, Whiston Hospital Mersey and West Lancashire Teaching Hospitals NHS Trust, Warrington Rd, Rainhill, Prescot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482140
- Sponsor's protocol ID
- 001GF
- Status last verified
- Nov 2025
- First submitted
- 15 Jul 2020
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Study to Evaluate the Safety and Performance of GENTA-FOIL Resorb® for the Prevention of Tissue Adhesions in Hand Surgery
- ClinicalTrials.gov ID
- NCT04482140
- Acronym / sponsor ID
- 001GF
- Conditions
- Tissue Adhesions, Surgery-Induced
- Keywords
- Hand Mobility, Wound Healing, Functional restoration
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow recruitment.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Advanced Medical Solutions Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Newcastle-upon-Tyne Hospitals NHS Trust, KAT General Hospital
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 7 Nov 2025 (actual)
- Study completion
- 7 Nov 2025 (actual)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genta-Foil resorb® | – | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- Subject is male or female, ≥18 years of age;
- Subject is willing and able to give written informed consent;
- Subject is scheduled for one if the following surgical procedures:
- Subject is willing and able to comply with the study procedures during surgery and the post-surgical follow up period.
Key exclusion criteria (8 listed)
- Subject is known to be sensitive to any of the device components e.g. Gentamicin (aminoglycosides) or equine collagen.
- Subject is known to be non-compliant with medical treatment.
- Subject has any known impaired renal function/autoimmune illness/neuromuscular disease (such as Parkinson's or Myasthenia Gravis).
- Subject is currently taking an Aminoglycoside antibiotic as stand-alone treatment or in combination with other antibiotics
- Subject is pregnant or actively breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genta-Foil resorb®Use of Genta-Foil resorb® to prevent adhesions in patients undergoing hand surgery | Device | Genta-Foil resorb® |
Primary outcome
Restoration of hand mobility
Time frame: At 90 days post-surgery
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.
6 secondary outcomes
Incidence of device related infections at surgical site up to 30 days post-surgery.
Time frame: Up to 30 days post-surgery
Incidence of device related adverse events
Time frame: Up to 90 days post-surgery
Subjective assessment of symptoms and abilities to perform activities by 90 days post-surgery
Time frame: At 90 days post-surgery
Wound healing without complications up to 30 days post-surgery.
Time frame: Up to 30 days
Change in patient pain scores (assessed using VAS) up to 90 days post-surgery.
Time frame: Up to 90 days post-surgery
Clinicians' satisfaction with the device at time of surgery
Time frame: Immediately post-surgery
Results and safety
The study was stopped early (reason given: slow recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Lipscombe principal investigator
Whiston Hospital Mersey and West Lancashire Teaching Hospitals NHS Trust, Warrington Rd, Rainhill, Prescot
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tissue Adhesions, Surgery-Induced, run by Advanced Medical Solutions Ltd. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration of hand mobility (time frame: At 90 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.