Finger InjuriesNCT04631081
Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation
A study testing coverage of the fingertips with bipedicled palmar island flap and occlusive dressing in people with Finger Injuries, run by Centre de la main - CHUV at 2 sites in Switzerland.
Trial summary
Our study aims to prospectively compare outcomes of conservative treatment (occlusive dressing) to surgery with a palmar bipedicled island flap (modified Tranquilli-Leali flap) in the management of Allen zones II-III-IV fingertip injuries in long fingers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Finger Injuries
- What is being tested?
- coverage of the fingertips with bipedicled palmar island flap and occlusive dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jul 2021to 1 Jul 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients > 18 years old
- Allen zones II-III-IV long finger amputation.
- Trauma < 48h.
Who cannot join
- Patients who are not able to give consent
- Injuries involving the DIP joint, extensor apparatus or requiring osteosynthesis.
- Chronic dermatological disorders of the hand, immunosuppressive drugs or chemotherapy. - Patient without a consent form would be excluded.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Recruiting
HUG
Geneva, 1205
Cindy Bouvet, MD, cindy.bouvet@hug.ch
Jean-Yves Beaulieu, Professor
- Recruiting
Hôpital du Valais
Sierre, Valais, 3960
Nicolas Balagué, MD, 0276037628 ext. 0041, nicolas.balague@hopitalvs.ch
Nicolas Balagué, MD
About this study
Official title: Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation: A Randomized Controlled Trial
Our study aims to prospectively compare outcomes of conservative treatment (occlusive dressing) to surgery with a palmar bipedicled island flap (modified Tranquilli-Leali flap) in the management of Allen zones II-III-IV fingertip injuries in long fingers. Based on these results, the investigators intend to help provide guidelines to optimize the management, and eventually the satisfaction of these patients.
Read the detailed description
The investigators intend to conduct a prospective tricentric (Hand Surgery Service in CHUV( Centre Hospitalier Universitaire Vaudois, Lausanne/ Hand Surgery Service in HUG (Hôpitaux Universitaire de Genève and Hand Surgery Service in Valais hospital, Sierre), open-label, randomized controlled trial: Occlusive dressing versus surgery in fingertips amputation.
The investigators will collect demographic data and informations about the injury including age, sex, medical history and daily medications, occupation, dominant hand, active smoking, mechanism of injury, associated injuries, time from injury to management, size and geometry (volar/transverse/dorsal) of defect, level of amputation (Allen classification), injury and repair of the nail bed.
Patients will be randomized into the occlusive dressing group or the surgical group on their first visit to the Hand Surgery department.
Both groups will have 6 months and 1-year follow-up appointment, including Ultrasound evaluation.
- Conditions
- Finger Injuries
- Being tested
- coverage of the fingertips with bipedicled palmar island flap, occlusive dressing
- Medical subject headings
- Finger Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coverage of the fingertips with bipedicled palmar island flapProcedure or surgery
The initial step is wound debridement. To design the flap, a longitudinal line is drawn at the junction of the volar and dorsal parts of the finger, starting from the distal part of the proximal interphalangeal joint flexion crease. It will be harvested from distal to proximal dissecting the digital canal plane. By releasing the Cleland and Grayson ligaments, the neurovascular bundle will be dissected. On the intermediate phalange, the dorsal branch of the neurovascular bundle must be preserved to maintain blood flow to the dorsal skin. Dissection is completed at the junction between the palmo-dorsal arteries and the collateral neurovascular bundles on both sides of the finger. A triangle may be resected at the distal edge of the flap to reshape of the pulp. Bone may be resected if needed to allow tension-free closure of the distal part of the flap. No Immobilization will be necessary.
occlusive dressingOther
patients will be evaluated on admission and benefit from wound irrigation, debridement and placement of a simple dressing with Adaptic or Jelonet, either in the Emergency department or in the Hand Surgery department. At 48 hours, they will be addressed to the Hand Surgery department to place a self-adhesive polyurethane film. Follow-up will include a visit at 1 week for dressing change, and then weekly for further dressing change until healing. Skin proximal to the injury will be degreased to increase adherence of the dressing. Distally, the film leaves a pocket to collect wound exudate. During treatment, the foul-smelling liquid produced by the wound and clots collected in the occlusive dressing will not be removed. A gauze covers the occlusive dressing to protect the liquid pocket and cover potential smell.
| Study group | Role | What they receive |
|---|---|---|
| Occlusive dressing group | Active comparator | patients will be evaluated on admission and benefit from wound irrigation, debridement and placement of a simple dressing with Adaptic or Jelonet, either in the Emergency department or in the Hand Surgery department. At 48 hours, they will be addressed to the Hand Surgery department to place a self-adhesive polyurethane film according. Follow-up will include a visit at 1 week for dressing change, and then weekly for further dressing change until healing Receives: Other: occlusive dressing |
| Surgical group | Active comparator | In surgical group, coverage with a bipedicled palmar island flap will be performed ambulatory, either on admission if patients are directly oriented to the Hand Surgery department, or within 48h of initial visit for patients addressed from the Emergency department. The flap group will be evaluated on admission, at 48h, and 6 weeks. Receives: Procedure: coverage of the fingertips with bipedicled palmar island flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's satisfaction assessment according to the therapeutic option (occlusive dressing vs flap).
Patients will be instructed to rate their satisfaction (according to different criteria: overall hand function, activities of daily living, work performance, pain, and cosmetic) by checking on a horizontal line their degree of satisfaction. After evaluation, their measurement was considered as a continuous measure (0-100 mm). Higher scores indicate better satisfaction.
Measured: Enrollment in the study for one year
Secondary outcomes (1)
Objective evaluation of fingertips
Distal fingertip sensibility (Semmens-Weinstein and 2 points discrimination test).
Finger range of motion of the PIP(Proximal InterPhalangeal) and DIP (Distal InterPhalangeal) joints (goniometer) Coloration and pigmentation of the pulp (Dermacatch). Dexterity (Nine hole peg test). Cold intolerance using the Cold Intolerance Symptom Severity (CISS) (40). Hook nail deformity. Distal phalanx bone length before and after treatment (X-Ray). Echography multiparameters analysis: thickness of the pulp (B-mode), vascularization of the pulp (Echo-doppler), Elasticity of the pulp (Shear wave elastography) (25).
Complications: infection rate, wound dehiscence rate, flap failure rate. Time of complete healing, time before returning to work.
Measured: Enrollment in the study for one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Jul 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Finger InjuriesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open-label, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre de la main - CHUV
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Sebastien Durand, MD,PhD, Principal investigator, Service de chirurgie plastique et de la main - CHUV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631081
- Sponsor's protocol ID
- 2020-01356
- Status last verified
- Sep 2021
- First submitted
- 10 Nov 2020
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sindhu K, DeFroda SF, Harris AP, Gil JA. Management of partial fingertip amputation in adults: Operative and non operative treatment. Injury. 2017 Dec;48(12):2643-2649. doi: 10.1016/j.injury.2017.10.042. Epub 2017 Oct 31.
PubMed 29100662Conn JM, Annest JL, Ryan GW, Budnitz DS. Non-work-related finger amputations in the United States, 2001-2002. Ann Emerg Med. 2005 Jun;45(6):630-5. doi: 10.1016/j.annemergmed.2004.10.012.
PubMed 15940097van den Berg WB, Vergeer RA, van der Sluis CK, Ten Duis HJ, Werker PM. Comparison of three types of treatment modalities on the outcome of fingertip injuries. J Trauma Acute Care Surg. 2012 Jun;72(6):1681-7. doi: 10.1097/TA.0b013e318248bc8c.
PubMed 22695441Hattori Y, Doi K, Ikeda K, Estrella EP. A retrospective study of functional outcomes after successful replantation versus amputation closure for single fingertip amputations. J Hand Surg Am. 2006 May-Jun;31(5):811-8. doi: 10.1016/j.jhsa.2006.02.020.
PubMed 16713848Sebastin SJ, Chung KC. A systematic review of the outcomes of replantation of distal digital amputation. Plast Reconstr Surg. 2011 Sep;128(3):723-737. doi: 10.1097/PRS.0b013e318221dc83.
PubMed 21572379Soucacos PN. Indications and selection for digital amputation and replantation. J Hand Surg Br. 2001 Dec;26(6):572-81. doi: 10.1054/jhsb.2001.0595.
PubMed 11884116Allen MJ. Conservative management of finger tip injuries in adults. Hand. 1980 Oct;12(3):257-65. doi: 10.1016/s0072-968x(80)80049-0.
PubMed 7002744Lee LP, Lau PY, Chan CW. A simple and efficient treatment for fingertip injuries. J Hand Surg Br. 1995 Feb;20(1):63-71. doi: 10.1016/s0266-7681(05)80019-1.
PubMed 7759939Lee DH, Mignemi ME, Crosby SN. Fingertip injuries: an update on management. J Am Acad Orthop Surg. 2013 Dec;21(12):756-66. doi: 10.5435/JAAOS-21-12-756.
PubMed 24292932Ma GF, Cheng JC, Chan KT, Chan KM, Leung PC. Finger tip injuries--a prospective study on seven methods of treatment on 200 cases. Ann Acad Med Singap. 1982 Apr;11(2):207-13.
PubMed 6753711Peterson SL, Peterson EL, Wheatley MJ. Management of fingertip amputations. J Hand Surg Am. 2014 Oct;39(10):2093-101. doi: 10.1016/j.jhsa.2014.04.025.
PubMed 25257490Russell RC, Casas LA. Management of fingertip injuries. Clin Plast Surg. 1989 Jul;16(3):405-25.
PubMed 2673624Tos P, Titolo P, Chirila NL, Catalano F, Artiaco S. Surgical treatment of acute fingernail injuries. J Orthop Traumatol. 2012 Jun;13(2):57-62. doi: 10.1007/s10195-011-0161-z. Epub 2011 Oct 8.
PubMed 21984203Tang JB, Elliot D, Adani R, Saint-Cyr M, Stang F. Repair and reconstruction of thumb and finger tip injuries: a global view. Clin Plast Surg. 2014 Jul;41(3):325-59. doi: 10.1016/j.cps.2014.04.004.
PubMed 24996458de Alwis W. Fingertip injuries. Emerg Med Australas. 2006 Jun;18(3):229-37. doi: 10.1111/j.1742-6723.2006.00851.x.
PubMed 16712532
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04631081
- Acronym / sponsor ID
- 2020-01356
- Conditions
- Finger Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre de la main - CHUVResearch network
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 17 Nov 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.
Our study aims to prospectively compare outcomes of conservative treatment (occlusive dressing) to surgery with a palmar bipedicled island flap (modified Tranquilli-Leali flap) in the management of Allen zones II-III-IV fingertip injuries in long fingers. Based on these results, the investigators intend to help provide guidelines to optimize the management, and eventually the satisfaction of these patients.
Detailed description
The investigators intend to conduct a prospective tricentric (Hand Surgery Service in CHUV( Centre Hospitalier Universitaire Vaudois, Lausanne/ Hand Surgery Service in HUG (Hôpitaux Universitaire de Genève and Hand Surgery Service in Valais hospital, Sierre), open-label, randomized controlled trial: Occlusive dressing versus surgery in fingertips amputation.
The investigators will collect demographic data and informations about the injury including age, sex, medical history and daily medications, occupation, dominant hand, active smoking, mechanism of injury, associated injuries, time from injury to management, size and geometry (volar/transverse/dorsal) of defect, level of amputation (Allen classification), injury and repair of the nail bed.
Patients will be randomized into the occlusive dressing group or the surgical group on their first visit to the Hand Surgery department.
Both groups will have 6 months and 1-year follow-up appointment, including Ultrasound evaluation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Occlusive dressing group | Active comparator | Other: occlusive dressingpatients will be evaluated on admission and benefit from wound irrigation, debridement and placement of a simple dressing with Adaptic or Jelonet, either in the Emergency department or in the Hand Surgery department. At 48 hours, they will be addressed to the Hand Surgery department to place a self-adhesive polyurethane film according. Follow-up will include a visit at 1 week for dressing change, and then weekly for further dressing change until healing |
| Surgical group | Active comparator | Procedure: coverage of the fingertips with bipedicled palmar island flapIn surgical group, coverage with a bipedicled palmar island flap will be performed ambulatory, either on admission if patients are directly oriented to the Hand Surgery department, or within 48h of initial visit for patients addressed from the Emergency department. The flap group will be evaluated on admission, at 48h, and 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 years old
- Allen zones II-III-IV long finger amputation.
- Trauma < 48h.
Key exclusion criteria (3 listed)
- Patients who are not able to give consent
- Injuries involving the DIP joint, extensor apparatus or requiring osteosynthesis.
- Chronic dermatological disorders of the hand, immunosuppressive drugs or chemotherapy. - Patient without a consent form would be excluded.
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 |
|---|---|---|
| coverage of the fingertips with bipedicled palmar island flapThe initial step is wound debridement. To design the flap, a longitudinal line is drawn at the junction of the volar and dorsal parts of the finger, starting from the distal part of the proximal interphalangeal joint flexion crease. It will be harvested from distal to proximal dissecting the digital canal plane. By releasing the Cleland and Grayson ligaments, the neurovascular bundle will be dissected. On the intermediate phalange, the dorsal branch of the neurovascular bundle must be preserved to maintain blood flow to the dorsal skin. Dissection is completed at the junction between the palmo-dorsal arteries and the collateral neurovascular bundles on both sides of the finger. A triangle may be resected at the distal edge of the flap to reshape of the pulp. Bone may be resected if needed to allow tension-free closure of the distal part of the flap. No Immobilization will be necessary. | Procedure or surgery | Surgical group |
| occlusive dressingpatients will be evaluated on admission and benefit from wound irrigation, debridement and placement of a simple dressing with Adaptic or Jelonet, either in the Emergency department or in the Hand Surgery department. At 48 hours, they will be addressed to the Hand Surgery department to place a self-adhesive polyurethane film. Follow-up will include a visit at 1 week for dressing change, and then weekly for further dressing change until healing. Skin proximal to the injury will be degreased to increase adherence of the dressing. Distally, the film leaves a pocket to collect wound exudate. During treatment, the foul-smelling liquid produced by the wound and clots collected in the occlusive dressing will not be removed. A gauze covers the occlusive dressing to protect the liquid pocket and cover potential smell. | Other | Occlusive dressing group |
Primary outcome
Patient's satisfaction assessment according to the therapeutic option (occlusive dressing vs flap).
Time frame: Enrollment in the study for one year
Patients will be instructed to rate their satisfaction (according to different criteria: overall hand function, activities of daily living, work performance, pain, and cosmetic) by checking on a horizontal line their degree of satisfaction. After evaluation, their measurement was considered as a continuous measure (0-100 mm). Higher scores indicate better satisfaction.
1 secondary outcome
Objective evaluation of fingertips
Time frame: Enrollment in the study for one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Results publication: PubMed 29100662Sindhu K, DeFroda SF, Harris AP, Gil JA. Management of partial fingertip amputation in adults: Operative and non operative treatment. Injury. 2017 Dec;48(12):2643-2649. doi: 10.1016/j.injury.2017.10.042. Epub 2017 Oct 31.
- Results publication: PubMed 15940097Conn JM, Annest JL, Ryan GW, Budnitz DS. Non-work-related finger amputations in the United States, 2001-2002. Ann Emerg Med. 2005 Jun;45(6):630-5. doi: 10.1016/j.annemergmed.2004.10.012.
- Results publication: PubMed 22695441van den Berg WB, Vergeer RA, van der Sluis CK, Ten Duis HJ, Werker PM. Comparison of three types of treatment modalities on the outcome of fingertip injuries. J Trauma Acute Care Surg. 2012 Jun;72(6):1681-7. doi: 10.1097/TA.0b013e318248bc8c.
- Results publication: PubMed 16713848Hattori Y, Doi K, Ikeda K, Estrella EP. A retrospective study of functional outcomes after successful replantation versus amputation closure for single fingertip amputations. J Hand Surg Am. 2006 May-Jun;31(5):811-8. doi: 10.1016/j.jhsa.2006.02.020.
- Results publication: PubMed 21572379Sebastin SJ, Chung KC. A systematic review of the outcomes of replantation of distal digital amputation. Plast Reconstr Surg. 2011 Sep;128(3):723-737. doi: 10.1097/PRS.0b013e318221dc83.
- Results publication: PubMed 11884116Soucacos PN. Indications and selection for digital amputation and replantation. J Hand Surg Br. 2001 Dec;26(6):572-81. doi: 10.1054/jhsb.2001.0595.
- Results publication: PubMed 7002744Allen MJ. Conservative management of finger tip injuries in adults. Hand. 1980 Oct;12(3):257-65. doi: 10.1016/s0072-968x(80)80049-0.
- Results publication: PubMed 7759939Lee LP, Lau PY, Chan CW. A simple and efficient treatment for fingertip injuries. J Hand Surg Br. 1995 Feb;20(1):63-71. doi: 10.1016/s0266-7681(05)80019-1.
- Results publication: PubMed 24292932Lee DH, Mignemi ME, Crosby SN. Fingertip injuries: an update on management. J Am Acad Orthop Surg. 2013 Dec;21(12):756-66. doi: 10.5435/JAAOS-21-12-756.
- Results publication: PubMed 6753711Ma GF, Cheng JC, Chan KT, Chan KM, Leung PC. Finger tip injuries--a prospective study on seven methods of treatment on 200 cases. Ann Acad Med Singap. 1982 Apr;11(2):207-13.
- Results publication: PubMed 25257490Peterson SL, Peterson EL, Wheatley MJ. Management of fingertip amputations. J Hand Surg Am. 2014 Oct;39(10):2093-101. doi: 10.1016/j.jhsa.2014.04.025.
- Results publication: PubMed 2673624Russell RC, Casas LA. Management of fingertip injuries. Clin Plast Surg. 1989 Jul;16(3):405-25.
- 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.
Sebastien Durand, MD,PhD principal investigator
Service de chirurgie plastique et de la main - CHUV
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coverage of the fingertips with bipedicled palmar island flap and occlusive dressing in people with Finger Injuries, run by Centre de la main - CHUV at 2 sites 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 3 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Sébastien Durand, MD, PhD (795567893 ext. 0041, sebastien.durand@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's satisfaction assessment according to the therapeutic option (occlusive dressing vs flap). (time frame: Enrollment in the study for one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04631081, which also lists 29 linked publications.
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 16 Sep 2021.