Digital Nerve InjuriesRETNCT05490940
Sensory Recovery of Digital Nerves After Microsurgical Epineural Neurorrhaphy Alone or in Combination With Tisseel - RET
A study testing Tisseel® in people with Digital Nerve Injuries, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Evaluation of sensitivity after primary surgical treatment of digital nerve injuries with microsurgical epineural end-to-end neurorrhaphy alone or in combination with the fibrin glue Tisseel® Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digital Nerve Injuries
- What is being tested?
- Tisseel®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2023to 31 Dec 2025
- Phase
- Interventional
- 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
Who may be able to join
- Written consent to participate in the study
- Acute digital nerve lesion(s) distal to the superficial arterial arch on one or more fingers that qualify for primary direct end-to-end microsurgical epineural neurorrhaphy
- Age ≥18 years
Who cannot join
- Lesions that do not allow a tension-free direct suture, partial transections, amputation, re-vascularisation
- Age < 18 years
- Pre-operation on the injured finger
- Clinical comparison with contralateral finger not possible (e.g. due to amputation).
- Treatment that is known to inhibit the growth/regeneration of nerves impaired or can cause neuropathy - such as chemo- or radiotherapy before or during the whole study
- Systemic and local neurological impairments (polyneuropathy, diabetes mellitus, carpal tunnel syndrome, etc.)
Show all 14Show fewer
- History of vascular diseases like Raynaud's disease syndrome that affects blood flow or sensation in the upper can affect the extremities
- Known or suspected non-compliance
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, or dementia
- Women who are pregnant (urin pregnancy test) or breast feeding. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- Previous enrolment into the current study
- Enrolment of the investigator, his/her family members, employees and other dependent persons
- Contraindications to the investigational product, e.g. known allergy to components of the Tisseel® fibrin glue
- Participation in another interventional study within the 30 days preceding and during the present study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Insel Gruppe AG
Bern, 3010
Esther Voegelin, Prof., +41 31 6323534, esther.voegelin@insel.ch
Léna Dietrich, Dr., +41 31 632 6440, lena.dietrich@insel.ch
About this study
Official title: A Prospective Randomized Study to Evaluate Sensory Recovery of Digital Nerves After Primary Repair Performed by Microsurgical Epineural End-to-end Neurorrhaphy Alone, or in Combination With an Enwrapping With Fibrin Sealant Tisseel®
Evaluation of sensitivity after primary surgical treatment of digital nerve injuries with microsurgical epineural end-to-end neurorrhaphy alone or in combination with the fibrin glue Tisseel®
Read the detailed description
Lacerations of the fingers with nerve injuries are a common reason for a presentation at the surgical emergency ward of the Inselspital Bern. The patient complains of either reduced sensitivity or even complete numbness in the affected finger. This leads to a clear functional loss in daily activities and should be reliably tested during the clinical examination. If a nerve lesion is suspected, the wound and the affected nerve should be explored in the operating room. If the suspicion is confirmed, the sheath of the two nerve endings can be sewn under the microscope or with surgical loupes.
Tension free microsurgical epineural end-to-end neurorrhaphy of digital nerves after sharp or blunt lesions is a simple and effective procedure in order to regain sensory recovery and prevent neuroma formation.
Industry is promoting different aids in order to achieve better outcomes after repair - such as tissue glue, grafts and conduits. These products are more or less expensive, which becomes more and more important as the general cost in the Swiss health system are progressively increasing.
The aim of this randomized, prospective controlled study is thus to compare the clinical benefit of a primary epineural end-to-end neurorrhaphy combined with fibrin glue (Tisseel®) versus a simple epineural end-to-end neurorrhaphy alone.
- Conditions
- Digital Nerve Injuries
- Being tested
- Tisseel®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tisseel®Drug
Also called Neurorraphy alone
The investigational medical product (IMP) in this study is Tisseel®, which is a tissue sealer consisting of two components:
- Sealer protein: Human fibrinogen as "glue" component and synthetic Aprotinin, which delays fibrinolysis.
- Human thrombin: Thrombin is an unique molecule that functions both as a procoagulant and anticoagulant. It activates platelets through its receptor on the platelets and regulates its own. generation by activating coagulation factors V, VIII and even XI resulting in a burst of thrombin formation.
Its indications are a better hemostasis, enforcement of vessel/gastrointestinal sutures and tissue sutures (mesh grafts, flaps etc).
| Study group | Role | What they receive |
|---|---|---|
| Microsurgical end-to-end neurorrhaphy alone | No intervention | This group of patients receives a simple, tension-free, end-to-end microsurgical neurorrhaphy alone (without fibrin glue) |
| Microsurgical end-to-end neurorrhaphy in combination with an enwrapping with fibrin sealant Tisseel® | Experimental | This group of patients receives a simple, tension-free, end-to-end microsurgical neurorrhaphy in combination with an enwrapping with fibrin sealant Tisseel®. Receives: Drug: Tisseel® |
What is being measured
The primary outcome is the main question the study is designed to answer.
two point discrimination
For this purpose a standardized two-point-discriminator (PADGETT DeMayo Two-Point Discrimination Device, Used for Post hand surgery diagnostic. MFID: PM-855) is used
Measured: preoperative
two point discrimination
For this purpose a standardized two-point-discriminator (PADGETT DeMayo Two-Point Discrimination Device, Used for Post hand surgery diagnostic. MFID: PM-855) is used
Measured: 6 weeks postoperative
two point discrimination
For this purpose a standardized two-point-discriminator (PADGETT DeMayo Two-Point Discrimination Device, Used for Post hand surgery diagnostic. MFID: PM-855) is used
Measured: 12 weeks postoperative
two point discrimination
For this purpose a standardized two-point-discriminator (PADGETT DeMayo Two-Point Discrimination Device, Used for Post hand surgery diagnostic. MFID: PM-855) is used
Measured: 24 weeks postoperative
Secondary outcomes (23)
Neuroma formation
- presence of Hofmann-Tinel sign
- Allodynographia/Mapping (Semmes-Weinstein Monofilament (SWMF) assessment as described by Spicher et al. (17); Sammons Preston Rolyan) performed by a trained hand therapist
- detection of a neuroma in ultrasound examination (measurement of three cross-section areas: proximal, distal and at the level of the neurorrhaphy) performed by a therefore certified hand surgeon (Philips iU22 Medical system or Philips 70 affiniti)
Measured: 6 weeks postoperative
Grip strength
using a JAMAR dynamometer
Measured: 12 weeks postoperative
Active range of motion
using a goniometer
Measured: 6 weeks postoperative
Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
Measured: 6 weeks postoperative
quickDASH score (Disabilities of the Shoulder, Arm and Hand)
a 11 item questionnaire: filled out by the patient
Measured: preoperative
STI-Test: (Shape-Texture Identification test)
This test is a standardized outcome measure of sensory function of the median and ulnar nerves of the hand: max. score for completed test = 6 points, min. score = 0
Measured: 12 weeks postoperative
Neuroma formation
- presence of Hofmann-Tinel sign
- Allodynographia/Mapping (Semmes-Weinstein Monofilament (SWMF) assessment as described by Spicher et al. (17); Sammons Preston Rolyan) performed by a trained hand therapist
- detection of a neuroma in ultrasound examination (measurement of three cross-section areas: proximal, distal and at the level of the neurorrhaphy) performed by a therefore certified hand surgeon (Philips iU22 Medical system or Philips 70 affiniti)
Measured: 12 weeks postoperative
Neuroma formation
- presence of Hofmann-Tinel sign
- Allodynographia/Mapping (Semmes-Weinstein Monofilament (SWMF) assessment as described by Spicher et al. (17); Sammons Preston Rolyan) performed by a trained hand therapist
- detection of a neuroma in ultrasound examination (measurement of three cross-section areas: proximal, distal and at the level of the neurorrhaphy) performed by a therefore certified hand surgeon (Philips iU22 Medical system or Philips 70 affiniti)
Measured: 24 weeks postoperative
Neuroma formation
- presence of Hofmann-Tinel sign
- Allodynographia/Mapping (Semmes-Weinstein Monofilament (SWMF) assessment as described by Spicher et al. (17); Sammons Preston Rolyan) performed by a trained hand therapist
- detection of a neuroma in ultrasound examination (measurement of three cross-section areas: proximal, distal and at the level of the neurorrhaphy) performed by a therefore certified hand surgeon (Philips iU22 Medical system or Philips 70 affiniti)
Measured: 48 weeks postoperative
Grip strength
using a JAMAR dynamometer
Measured: 24 weeks postoperative
Grip strength
using a JAMAR dynamometer
Measured: 48 weeks postoperative
Active range of motion
using a goniometer
Measured: 12 weeks postoperative
Active range of motion
using a goniometer
Measured: 24 weeks postoperative
Active range of motion
using a goniometer
Measured: 48 weeks postoperative
Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
Measured: 12 weeks postoperative
Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
Measured: 24 weeks postoperative
Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
Measured: 48 weeks postoperative
quickDASH score (Disabilities of the Shoulder, Arm and Hand)
a 11 item questionnaire: filled out by the patient
Measured: 6 weeks postoperative
quickDASH score (Disabilities of the Shoulder, Arm and Hand)
a 11 item questionnaire: filled out by the patient
Measured: 12 weeks postoperative
quickDASH score (Disabilities of the Shoulder, Arm and Hand)
a 11 item questionnaire: filled out by the patient
Measured: 24 weeks postoperative
quickDASH score (Disabilities of the Shoulder, Arm and Hand)
a 11 item questionnaire: filled out by the patient
Measured: 48 weeks postoperative
STI-Test: (Shape-Texture Identification test)
This test is a standardized outcome measure of sensory function of the median and ulnar nerves of the hand: max. score for completed test = 6 points, min. score = 0
Measured: 24 weeks postoperative
STI-Test: (Shape-Texture Identification test)
This test is a standardized outcome measure of sensory function of the median and ulnar nerves of the hand: max. score for completed test = 6 points, min. score = 0
Measured: 48 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Mar 2023 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomised, investigator-blinded, monocentric study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Esther Vögelin, Prof. Dr., Study chair, Insel Gruppe AG, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490940
- Sponsor's protocol ID
- 2021-02050
- Acronym
- RET
- Status last verified
- Mar 2023
- First submitted
- 6 Jul 2022
- Last updated
- 3 Mar 2023
- 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 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study to Evaluate Sensory Recovery of Digital Nerves After Primary Repair Performed by Microsurgical Epineural End-to-end Neurorrhaphy Alone, or in Combination With an Enwrapping With Fibrin Sealant Tisseel®
- ClinicalTrials.gov ID
- NCT05490940
- Acronym / sponsor ID
- RET / 2021-02050
- Conditions
- Digital Nerve Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Aug 2022 (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.
Evaluation of sensitivity after primary surgical treatment of digital nerve injuries with microsurgical epineural end-to-end neurorrhaphy alone or in combination with the fibrin glue Tisseel®
Detailed description
Lacerations of the fingers with nerve injuries are a common reason for a presentation at the surgical emergency ward of the Inselspital Bern. The patient complains of either reduced sensitivity or even complete numbness in the affected finger. This leads to a clear functional loss in daily activities and should be reliably tested during the clinical examination. If a nerve lesion is suspected, the wound and the affected nerve should be explored in the operating room. If the suspicion is confirmed, the sheath of the two nerve endings can be sewn under the microscope or with surgical loupes.
Tension free microsurgical epineural end-to-end neurorrhaphy of digital nerves after sharp or blunt lesions is a simple and effective procedure in order to regain sensory recovery and prevent neuroma formation.
Industry is promoting different aids in order to achieve better outcomes after repair - such as tissue glue, grafts and conduits. These products are more or less expensive, which becomes more and more important as the general cost in the Swiss health system are progressively increasing.
The aim of this randomized, prospective controlled study is thus to compare the clinical benefit of a primary epineural end-to-end neurorrhaphy combined with fibrin glue (Tisseel®) versus a simple epineural end-to-end neurorrhaphy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomised, investigator-blinded, monocentric study
| Arm | Type | Receives |
|---|---|---|
| Microsurgical end-to-end neurorrhaphy alone | No intervention | –This group of patients receives a simple, tension-free, end-to-end microsurgical neurorrhaphy alone (without fibrin glue) |
| Microsurgical end-to-end neurorrhaphy in combination with an enwrapping with fibrin sealant Tisseel® | Experimental | Drug: Tisseel®This group of patients receives a simple, tension-free, end-to-end microsurgical neurorrhaphy in combination with an enwrapping with fibrin sealant Tisseel®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written consent to participate in the study
- Acute digital nerve lesion(s) distal to the superficial arterial arch on one or more fingers that qualify for primary direct end-to-end microsurgical epineural neurorrhaphy
- Age ≥18 years
Key exclusion criteria (14 listed)
- Lesions that do not allow a tension-free direct suture, partial transections, amputation, re-vascularisation
- Age < 18 years
- Pre-operation on the injured finger
- Clinical comparison with contralateral finger not possible (e.g. due to amputation).
- Treatment that is known to inhibit the growth/regeneration of nerves impaired or can cause neuropathy - such as chemo- or radiotherapy before or during the whole study
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 |
|---|---|---|
| Tisseel®Also: Neurorraphy aloneThe investigational medical product (IMP) in this study is Tisseel®, which is a tissue sealer consisting of two components: 1. Sealer protein: Human fibrinogen as "glue" component and synthetic Aprotinin, which delays fibrinolysis. 2. Human thrombin: Thrombin is an unique molecule that functions both as a procoagulant and anticoagulant. It activates platelets through its receptor on the platelets and regulates its own. generation by activating coagulation factors V, VIII and even XI resulting in a burst of thrombin formation. Its indications are a better hemostasis, enforcement of vessel/gastrointestinal sutures and tissue sutures (mesh grafts, flaps etc). | Drug | Microsurgical end-to-end neurorrhaphy in combination with an enwrapping with fibrin sealant Tisseel® |
Primary outcome
two point discrimination
Time frame: preoperative
For this purpose a standardized two-point-discriminator (PADGETT DeMayo Two-Point Discrimination Device, Used for Post hand surgery diagnostic. MFID: PM-855) is used
two point discrimination
Time frame: 6 weeks postoperative
For this purpose a standardized two-point-discriminator (PADGETT DeMayo Two-Point Discrimination Device, Used for Post hand surgery diagnostic. MFID: PM-855) is used
two point discrimination
Time frame: 12 weeks postoperative
For this purpose a standardized two-point-discriminator (PADGETT DeMayo Two-Point Discrimination Device, Used for Post hand surgery diagnostic. MFID: PM-855) is used
two point discrimination
Time frame: 24 weeks postoperative
For this purpose a standardized two-point-discriminator (PADGETT DeMayo Two-Point Discrimination Device, Used for Post hand surgery diagnostic. MFID: PM-855) is used
23 secondary outcomes
Neuroma formation
Time frame: 6 weeks postoperative
Grip strength
Time frame: 12 weeks postoperative
Active range of motion
Time frame: 6 weeks postoperative
Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
Time frame: 6 weeks postoperative
quickDASH score (Disabilities of the Shoulder, Arm and Hand)
Time frame: preoperative
STI-Test: (Shape-Texture Identification test)
Time frame: 12 weeks postoperative
Neuroma formation
Time frame: 12 weeks postoperative
Neuroma formation
Time frame: 24 weeks postoperative
Neuroma formation
Time frame: 48 weeks postoperative
Grip strength
Time frame: 24 weeks postoperative
Grip strength
Time frame: 48 weeks postoperative
Active range of motion
Time frame: 12 weeks postoperative
Active range of motion
Time frame: 24 weeks postoperative
Active range of motion
Time frame: 48 weeks postoperative
Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
Time frame: 12 weeks postoperative
Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
Time frame: 24 weeks postoperative
Pain with the Numeric Rating Scale (NRS): 0 indicating no and 10 indicating maximum pain
Time frame: 48 weeks postoperative
quickDASH score (Disabilities of the Shoulder, Arm and Hand)
Time frame: 6 weeks postoperative
quickDASH score (Disabilities of the Shoulder, Arm and Hand)
Time frame: 12 weeks postoperative
quickDASH score (Disabilities of the Shoulder, Arm and Hand)
Time frame: 24 weeks postoperative
quickDASH score (Disabilities of the Shoulder, Arm and Hand)
Time frame: 48 weeks postoperative
STI-Test: (Shape-Texture Identification test)
Time frame: 24 weeks postoperative
STI-Test: (Shape-Texture Identification test)
Time frame: 48 weeks postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- 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.
Esther Vögelin, Prof. Dr. study chair
Insel Gruppe AG, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tisseel® in people with Digital Nerve Injuries, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esther Voegelin, Prof. Dr. (+41316328014 ext. +41794401987, esther.voegelin@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
two point discrimination (time frame: preoperative). The study lists 4 primary outcomes in all. 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 3 Mar 2023.