- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04631081
Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation
Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sébastien Durand, MD, PhD
- Phone Number: 0041 795567893
- Email: sebastien.durand@chuv.ch
Study Contact Backup
- Name: Leslie Elahi
- Phone Number: 0041 795560189
- Email: leslie.rausis@chuv.ch
Study Locations
-
-
-
Genève, Switzerland, 1205
- Recruiting
- HUG
-
Contact:
- Cindy Bouvet, MD
- Email: cindy.bouvet@hug.ch
-
Contact:
- Jean-Yves Beaulieu, Professor
-
-
Valais
-
Sierre, Valais, Switzerland, 3960
- Recruiting
- Hopital du Valais
-
Contact:
- Nicolas Balagué, MD
- Phone Number: 0041 0276037628
- Email: nicolas.balague@hopitalvs.ch
-
Sub-Investigator:
- Nicolas Balagué, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients > 18 years old
- Allen zones II-III-IV long finger amputation.
- Trauma < 48h.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Occlusive dressing group
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
|
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.
|
Active Comparator: Surgical group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Enrollment in the study for one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective evaluation of fingertips
Time Frame: Enrollment in the study for one year
|
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. |
Enrollment in the study for one year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sebastien Durand, MD,PhD, Service de chirurgie plastique et de la main - CHUV
Publications and helpful links
General Publications
- Germann G, Rudolf KD, Levin SL, Hrabowski M. Fingertip and Thumb Tip Wounds: Changing Algorithms for Sensation, Aesthetics, and Function. J Hand Surg Am. 2017 Apr;42(4):274-284. doi: 10.1016/j.jhsa.2017.01.022.
- 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.
- Conn 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.
- van 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.
- Hattori 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.
- Sebastin 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.
- Soucacos 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.
- Allen MJ. Conservative management of finger tip injuries in adults. Hand. 1980 Oct;12(3):257-65. doi: 10.1016/s0072-968x(80)80049-0.
- Lee 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.
- Lee 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.
- Ma 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.
- Peterson 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.
- Russell RC, Casas LA. Management of fingertip injuries. Clin Plast Surg. 1989 Jul;16(3):405-25.
- Tos 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.
- Tang 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.
- de Alwis W. Fingertip injuries. Emerg Med Australas. 2006 Jun;18(3):229-37. doi: 10.1111/j.1742-6723.2006.00851.x.
- Stevenson TR. Fingertip and nailbed injuries. Orthop Clin North Am. 1992 Jan;23(1):149-59.
- Krauss EM, Lalonde DH. Secondary healing of fingertip amputations: a review. Hand (N Y). 2014 Sep;9(3):282-8. doi: 10.1007/s11552-014-9663-5.
- Weichman KE, Wilson SC, Samra F, Reavey P, Sharma S, Haddock NT. Treatment and outcomes of fingertip injuries at a large metropolitan public hospital. Plast Reconstr Surg. 2013 Jan;131(1):107-112. doi: 10.1097/PRS.0b013e3182729ec2.
- Panattoni JB, De Ona IR, Ahmed MM. Reconstruction of fingertip injuries: surgical tips and avoiding complications. J Hand Surg Am. 2015 May;40(5):1016-24. doi: 10.1016/j.jhsa.2015.02.010. Epub 2015 Mar 29.
- Saraf S, Tiwari V. Fingertip injuries. Indian J Orthop. 2007 Apr;41(2):163-8. doi: 10.4103/0019-5413.32051.
- Lemmon JA, Janis JE, Rohrich RJ. Soft-tissue injuries of the fingertip: methods of evaluation and treatment. An algorithmic approach. Plast Reconstr Surg. 2008 Sep;122(3):105e-117e. doi: 10.1097/PRS.0b013e3181823be0.
- Hoigne D, Hug U, Schurch M, Meoli M, von Wartburg U. Semi-occlusive dressing for the treatment of fingertip amputations with exposed bone: quantity and quality of soft-tissue regeneration. J Hand Surg Eur Vol. 2014 Jun;39(5):505-9. doi: 10.1177/1753193413489639. Epub 2013 May 21.
- Dumontier C, Gilbert A, Tubiana R. Hook-nail deformity. Surgical treatment with a homodigital advancement flap. J Hand Surg Br. 1995 Dec;20(6):830-5. doi: 10.1016/s0266-7681(95)80057-3.
- Jafari P, Muller C, Grognuz A, Applegate LA, Raffoul W, di Summa PG, Durand S. First Insights into Human Fingertip Regeneration by Echo-Doppler Imaging and Wound Microenvironment Assessment. Int J Mol Sci. 2017 May 13;18(5):1054. doi: 10.3390/ijms18051054.
- Wang L, Yuan SY. A simple and direct procedure for excision of peripheral skin above the nail root to enable nail lengthening after fingertip amputation. J Plast Reconstr Aesthet Surg. 2012 Sep;65(9):e265-6. doi: 10.1016/j.bjps.2012.03.022. Epub 2012 Apr 3. No abstract available.
- Serane-Fresnel J, Lafosse T, Amsallem L, Chaves C, Delpit X, Chassat R, Masmejean EH. Fingertip reconstruction by palmar bipedicular island flap in long fingers (modified neurovascular Tranquilli-Leali flap): A dual-center study. Hand Surg Rehabil. 2020 Feb;39(1):59-64. doi: 10.1016/j.hansur.2019.11.003. Epub 2019 Nov 15.
- Clark DP, Scott RN, Anderson IW. Hand problems in an accident and emergency department. J Hand Surg Br. 1985 Oct;10(3):297-9. doi: 10.1016/s0266-7681(85)80047-4.
- Quell M, Neubauer T, Wagner M. [Treatment of fingertip defect injuries with a semi-occlusive dressing]. Handchir Mikrochir Plast Chir. 1998 Jan;30(1):24-9. German.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-01356
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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