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
  Purpose

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.


Condition Intervention Phase
Skin Lesions
Device: Innothera's brand Stockings
Other: Stockings other than Innothera's brand
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Exploratory Comparative Single-blind Study Evaluating Tolerability of the Silicone Bands on Medical Compression Stockings

Further study details as provided by Laboratoires Innothera:

Primary Outcome Measures:
  • 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


Enrollment: 3
Study Start Date: November 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Innothera's brand Stokings
Innothera's branded grip-top silicone band stokingc
Device: Innothera's brand Stockings
15 patients having used Innothera branded Stocking
Other Name: Medical compression stockings
Other than Innothera's brand 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01486225

Locations
France
Hôpitaux de Brabois CHU de Nancy
Nancy, France, 54500
Sponsors and Collaborators
Laboratoires Innothera
Investigators
Principal Investigator: Annick BARBAUD, MD Professor CHU de Nancy
  More Information

No publications provided

Responsible Party: Laboratoires Innothera
ClinicalTrials.gov Identifier: NCT01486225     History of Changes
Other Study ID Numbers: CVE401-10
Study First Received: August 10, 2011
Last Updated: August 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on August 26, 2014