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Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation

Primary Purpose

Finger Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
coverage of the fingertips with bipedicled palmar island flap
occlusive dressing
Sponsored by
Centre de la main - CHUV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Finger Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hôpital du ValaisRecruiting
  • HUGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Occlusive dressing group

Surgical group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 10, 2020
Last Updated
September 8, 2021
Sponsor
Centre de la main - CHUV
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1. Study Identification

Unique Protocol Identification Number
NCT04631081
Brief Title
Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation
Official Title
Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre de la main - CHUV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Finger Injuries

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
open-label, randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Occlusive dressing group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Surgical group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
coverage of the fingertips with bipedicled palmar island flap
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
occlusive dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient's satisfaction assessment according to the therapeutic option (occlusive dressing vs flap).
Description
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.
Time Frame
Enrollment in the study for one year
Secondary Outcome Measure Information:
Title
Objective evaluation of fingertips
Description
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.
Time Frame
Enrollment in the study for one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sébastien Durand, MD, PhD
Phone
795567893
Ext
0041
Email
sebastien.durand@chuv.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Leslie Elahi
Phone
795560189
Ext
0041
Email
leslie.rausis@chuv.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien Durand, MD,PhD
Organizational Affiliation
Service de chirurgie plastique et de la main - CHUV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital du Valais
City
Sierre
State/Province
Valais
ZIP/Postal Code
3960
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Balagué, MD
Phone
0276037628
Ext
0041
Email
nicolas.balague@hopitalvs.ch
First Name & Middle Initial & Last Name & Degree
Nicolas Balagué, MD
Facility Name
HUG
City
Genève
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cindy Bouvet, MD
Email
cindy.bouvet@hug.ch
First Name & Middle Initial & Last Name & Degree
Jean-Yves Beaulieu, Professor

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29100662
Citation
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.
Results Reference
result
PubMed Identifier
15940097
Citation
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.
Results Reference
result
PubMed Identifier
22695441
Citation
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.
Results Reference
result
PubMed Identifier
16713848
Citation
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.
Results Reference
result
PubMed Identifier
21572379
Citation
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.
Results Reference
result
PubMed Identifier
11884116
Citation
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.
Results Reference
result
PubMed Identifier
7002744
Citation
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.
Results Reference
result
PubMed Identifier
7759939
Citation
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.
Results Reference
result
PubMed Identifier
24292932
Citation
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.
Results Reference
result
PubMed Identifier
6753711
Citation
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.
Results Reference
result
PubMed Identifier
25257490
Citation
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.
Results Reference
result
PubMed Identifier
2673624
Citation
Russell RC, Casas LA. Management of fingertip injuries. Clin Plast Surg. 1989 Jul;16(3):405-25.
Results Reference
result
PubMed Identifier
21984203
Citation
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.
Results Reference
result
PubMed Identifier
24996458
Citation
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.
Results Reference
result
PubMed Identifier
16712532
Citation
de Alwis W. Fingertip injuries. Emerg Med Australas. 2006 Jun;18(3):229-37. doi: 10.1111/j.1742-6723.2006.00851.x.
Results Reference
result
PubMed Identifier
1729663
Citation
Stevenson TR. Fingertip and nailbed injuries. Orthop Clin North Am. 1992 Jan;23(1):149-59.
Results Reference
result
PubMed Identifier
25191157
Citation
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.
Results Reference
result
PubMed Identifier
22965236
Citation
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.
Results Reference
result
PubMed Identifier
25823622
Citation
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.
Results Reference
result
PubMed Identifier
28372640
Citation
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.
Results Reference
result
PubMed Identifier
21139772
Citation
Saraf S, Tiwari V. Fingertip injuries. Indian J Orthop. 2007 Apr;41(2):163-8. doi: 10.4103/0019-5413.32051.
Results Reference
result
PubMed Identifier
18766028
Citation
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.
Results Reference
result
PubMed Identifier
23695151
Citation
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.
Results Reference
result
PubMed Identifier
8770751
Citation
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.
Results Reference
result
PubMed Identifier
28505080
Citation
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.
Results Reference
result
PubMed Identifier
22475687
Citation
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.
Results Reference
result
PubMed Identifier
31740268
Citation
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.
Results Reference
result
PubMed Identifier
4078454
Citation
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.
Results Reference
result
PubMed Identifier
9541835
Citation
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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.project-redcap.org/

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Occlusive Dressing vs Palmar Pedicular Island Flap in Fingertip Amputation

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