The Occlusive Dressing

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT01002638
First received: October 26, 2009
Last updated: June 7, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Fingertips Traumatic Amputations
Other: TEGADERM®
Procedure: Surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Occlusive Dressing: a Comparative Randomized Trial on 2 Procedures of Treatment of Fingertips Traumatic Amputations

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:
  • the tactile sensibility will be tested by standardized monofilaments [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Occlusive Dressing Other: TEGADERM®
It consists of the occlusive application of two Tegaderm®, a plastic dressing
Active Comparator: Surgery Procedure: Surgery
It consists of pulp reconstruction by a flap (for example palmar V-Y advancement flaps of Atazoy).

Detailed Description:

This is a multicentre, randomized study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002638

Contacts
Contact: Philippe LIVERNEAUX, MD 03 88 55 23 13 ext 0033 philippe.liverneaux@chru-strasbourg.fr

Locations
France
University Hospital Recruiting
Besançon, France, 25000
Contact: Laurent OBERT, MD         
Principal Investigator: Laurent OBERT, MD         
University Hospital Active, not recruiting
Bordeaux, France, 34000
University Hospital Recruiting
Strasbourg, France
Principal Investigator: Sybille FACCA, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: philippe LIVERNEAUX, MD University Hospital, Strasbourg, France
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01002638     History of Changes
Other Study ID Numbers: 4436
Study First Received: October 26, 2009
Last Updated: June 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Amputation, Traumatic
Wounds and Injuries

ClinicalTrials.gov processed this record on October 01, 2014