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Tolerance Study of the Silicone Bands on Medical Compression Stockings

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Laboratoires Innothera
ClinicalTrials.gov Identifier:
NCT01486225
First received: August 10, 2011
Last updated: August 7, 2014
Last verified: July 2012

August 10, 2011
August 7, 2014
November 2011
October 2013   (final data collection date for primary outcome measure)
nature and outcome of skin lesion caused by the silicone from the grip-top band of medical stockings [ Time Frame: within 5 days from skin lesion started ] [ Designated as safety issue: No ]
Patient will be followed during 5 days from the time that lessions occurs
Same as current
Complete list of historical versions of study NCT01486225 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Tolerance Study of the Silicone Bands on Medical Compression Stockings
Exploratory Comparative Single-blind Study Evaluating Tolerability of the Silicone Bands on Medical Compression Stockings

The purpose of this study is to identify the nature of skin lesions that develop on contact with the grip-top bands of medical compression stockings, which are composed mainly of silicone.

To identify the nature of lesions the investigator will analyse results of the biopsys, microbiological analyses, dermatological tests.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Skin Lesions
  • Device: Innothera's brand Stockings
    15 patients having used Innothera branded Stocking
    Other Name: Medical compression stockings
  • Other: Stockings other than Innothera's brand
    15 patients having used any other brand than Innothera's brand stockings
    Other Names:
    • Other Names:
    • Medical compression stockings
  • Innothera's brand Stokings
    Innothera's branded grip-top silicone band stokingc
    Intervention: Device: Innothera's brand Stockings
  • Other than Innothera's brand
    Intervention: Other: Stockings other than Innothera's brand
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who notified a health care professional (doctor or pharmacist) of an incident with a grip-top bands compression stocking, regardless of brand and model.
  • Subjects presenting skin lesions caused by the contact with silicone-containing grip-top bands of medical compression stockings (all brands combined).
  • Subjects for whom the incriminated stockings provide class 2 compression or higher.
  • Subjects covered by French national health insurance.
  • Subjects who give their written informed consent and who accept the constraints of the study.

Exclusion Criteria:

  • Known allergy to local anesthetics (lidocaine, etc.).
  • History of anaphylactic shock.
  • Ongoing antihistamine treatment or having taken during the week before inclusion.
  • Patient on ongoing systemic corticosteroids or having taken corticosteroids in the month before inclusion.
  • Patient having used a topical corticosteroid in the area where the patch tests or prick tests will be performed during the week before inclusion.
  • Phototherapy or sun exposure in the 30 days preceding the skin tests (on the back).
  • Patient having concomitantly used compression stockings and a topical corticosteroid on the thighs in the 48 hours preceding lesion onset.
  • List of diseases which will prevent a subject from participating in the study:
  • acquired, infectious or drug-induced congenital immunosuppression (systemic corticosteroid therapy, immunosuppressives, chemotherapy),
  • Congenital bullous disorder (congenital epidermolysis bullosa) or acquired bullous disorder (pemphigus, pemphigoid, dermatitis herpetiformis, linear IgA dermatosis, etc.).
  • Patients with an ongoing or previous history of mental or psychiatric disorder or condition or any other factor interfering with the ability to give informed consent.
  • Any major systemic disease making the conduct of the study or the interpretation of the results difficult.
  • Patients with ongoing or previous history of decompensated heart failure.
  • Chemotherapy or active cancer.
  • Pregnancy.
  • Patients participating in an ongoing clinical trial or in the exclusion period of a previous trial.
  • Persons deprived of their liberty by judicial or administrative decision or persons hospitalized without their consent.
  • Legally protected adults under guardianship.
  • If the patient accepts the biopsy proposed in the study:
  • Patient for whom a skin biopsy is contra-indicated or requiring antibiotic prophylaxis,
  • Anticoagulant taken during the 24 hours before inclusion.
  • Subject with history of allergy to natural or synthetic latex, chlorhexidine, known healing disorder and/or viral diseases transmissible through the blood documented by the preliminary clinical exam.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01486225
CVE401-10
No
Laboratoires Innothera
Laboratoires Innothera
Not Provided
Principal Investigator: Annick BARBAUD, MD Professor CHU de Nancy
Laboratoires Innothera
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP