The Occlusive Dressing
Primary Purpose
Fingertips Traumatic Amputations
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TEGADERM®
Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Fingertips Traumatic Amputations
Eligibility Criteria
Inclusion Criteria:
- Adult
- Fingertips traumatic amputations (zone 2 or 3)
Exclusion Criteria:
- Fingertips traumatic amputations (zone 1 or 4)
- Fingertips amputations non traumatic
- Traumatic history on the finger,, nervous traumatism or nerve tumor on the same upper limb
- Nervous tumor history or cervical spine traumatism
Sites / Locations
- University Hospital
- University Hospital
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Occlusive Dressing
Surgery
Arm Description
Outcomes
Primary Outcome Measures
the tactile sensibility will be tested by standardized monofilaments
Secondary Outcome Measures
Full Information
NCT ID
NCT01002638
First Posted
October 26, 2009
Last Updated
August 24, 2018
Sponsor
University Hospital, Strasbourg, France
1. Study Identification
Unique Protocol Identification Number
NCT01002638
Brief Title
The Occlusive Dressing
Official Title
The Occlusive Dressing: a Comparative Randomized Trial on 2 Procedures of Treatment of Fingertips Traumatic Amputations
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
recruitment difficulty
Study Start Date
December 2009 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Fingers amputations are very common injuries among the patients arriving at the Emergency Department. Fingertips amputations classified in 2nd and 3rd zones, in accordance with Rosenthal's classification (after the solum unguis), constitute a large proportion of them. The treatment aims at restoring a pulp with its sensitivity and a good subcutaneous fat tissue. The usual care of these amputations is a surgical treatment: it consists of pulp reconstruction by a flap (for example palmar V-Y advancement flaps of Atazoy). These technique involve hospital admission, brachial plexus anaesthesia, a surgical approach with cicatrix and donor site morbidities, postoperative cares, post-surgical pain management. And of course attention must be paid to the risks of postoperative complications related either to anaesthesia and/or to surgery, like necrosis, infection, and others. We have developed a nonoperative treatment for fingertips amputations: the occlusive dressing. It's a technique that has been known for about twenty years, and that is currently developed by the teams SOS main of Professor Liverneaux in Strasbourg and of Professor Obert in Besançon. It consists of the occlusive application of two Tegaderm®, a plastic dressing. Then the finger macerates in an anaerobic medium, and could develop an uncomfortable smell induced by maceration process. The first results described by the preclinical studies of these two groups look satisfying on both the functional aspect (sensibility) and the aesthetic component (preservation of the finger length and curve), as well as for healing that occurs without infection. Moreover, the length of the treatment is of about only three or four weeks, and its cost is very low by comparison with the cost of the surgery itself. Nevertheless this technique is still not very common, and it has been reported in only five references in the literature [Mennen & Al., Farrell & Al., Lee & Al., Allen & Al., Tago Hiroyuk & Al.]. On the other hand, the mechanism of action and/or the active components of this occlusive dressing have not yet been the objects of extended studies. An explanatory hypothesis is that some anaerobic germs and/or growth factors might play an active role in the process. However, they have not been identified yet. The aim of our study is to validate through clinical and biological criteria this non operative method and to compare with surgical treatment. The study will be held in the Hand Department of the University Hospital of Strasbourg, under the direction of the Pr Liverneaux. It will imply the collaboration of the laboratory of medical bacteriology directed by Pr Piemont, and the research department of INSERM (Parogène laboratory) will focus on the biochemistry. From a clinical point of view, a certain number of objective functional criteria will be measured: the pain will be evaluated by a visual analogic scale and the DN4 scale; the functional disability will be measured with the french version of the Disability Arm Shoulder Hand of Dubert; the pulpar 3D volume will be calculated from the numerical pictures with a computerized file, the cutaneous depth will be measured by 3D U.S; the tactile sensibility will be tested by standardized monofilaments and Weber's test and the dermatoglyphics of both handsides will be compared. In addition, the subjective feeling of the patients will be recorded through a visual and analogical scale of satisfaction. The purpose of the biological component of the study will be to put into light and to identify the components that are active in the process. This will be performed by the direct examination and by bacteriological cultures, and will look for the anaerobic, aerobic germs and the yeasts.The biochemical studies will first include a non specific search of growth factors, cytokines and interleukins. In a second step, specific researches will be undertaken if necessary in accordance with the results of the first investigations. By this study, the investigators would like to scientifically confirm the efficiency of this method with objective as well as subjective criteria, and to identify the underlying biomechanisms of the process.
Detailed Description
This is a multicentre, randomized study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fingertips Traumatic Amputations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Occlusive Dressing
Arm Type
Experimental
Arm Title
Surgery
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
TEGADERM®
Intervention Description
It consists of the occlusive application of two Tegaderm®, a plastic dressing
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
It consists of pulp reconstruction by a flap (for example palmar V-Y advancement flaps of Atazoy).
Primary Outcome Measure Information:
Title
the tactile sensibility will be tested by standardized monofilaments
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult
Fingertips traumatic amputations (zone 2 or 3)
Exclusion Criteria:
Fingertips traumatic amputations (zone 1 or 4)
Fingertips amputations non traumatic
Traumatic history on the finger,, nervous traumatism or nerve tumor on the same upper limb
Nervous tumor history or cervical spine traumatism
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
philippe LIVERNEAUX, MD
Organizational Affiliation
University Hospital, Strasbourg, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Besançon
ZIP/Postal Code
25000
Country
France
Facility Name
University Hospital
City
Bordeaux
ZIP/Postal Code
34000
Country
France
Facility Name
University Hospital
City
Strasbourg
Country
France
12. IPD Sharing Statement
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