Evaluation of Pain Associated With the Removal of Wound Dressing During Care of Venous Leg Ulcer. Comparison of the Efficacy and Safety of Two Dressings Urgotul and TulleGras

NCT02104180 | Completed Results

• 2 other identifiers: LINE40012013-A01285-40
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 27

Brief Summary

Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer

Conditions

Venous Leg Ulcer

Keywords

non-inferiority; randomized; TulleGras; Urgotul; pain; venous leg ulcer; healing

Outcome Measures

Primary Outcomes (1)

• Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal

  Pain intensity experienced by subjects associated to removal of each study primary dressings during the care, assessed at of the Cross-over Period on a visual analogue scale (VAS). The VAS was provided as a 100 mm, non-graduated horizontal line, with extremities indicating " no pain " (0) and " extreme pain " (100). The subject responded by drawing a vertical line to assess the pain intensity he/she experienced at the time of removal of the primary wound dressing.

  at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3)

Study Arms (2)

TulleGras M.S.

ACTIVE COMPARATOR

Device: TulleGras M.S.

Urgotul

ACTIVE COMPARATOR

Device: Urgotul

Interventions

Urgotul DEVICE

sterile, hydrocolloid dressing, that consist of a polyester fabric coated with hydrocolloid particles and vaseline

Urgotul

TulleGras M.S. DEVICE

Sterile dressing that consists of viscose tissue coated with mineral vaseline

TulleGras M.S.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject informed of the objectives, purpose, details and constraints of the study and who has given his/her written informed consent.
• Male or female subject.
• Subject at least 45 years of age.
• Subject presenting with an open venous leg ulcer.

You may not qualify if:

• Related to the disease studied:
• Venous leg ulcer at start of cleaning phase;
• Fibrinous and dry ulcer (non exudative wound) or on the contrary highly exudative and/or hemorrhagic.
• Venous leg ulcer with signs of critical colonization or clinically infected.
• Cancerous venous leg ulcer.
• Related to the subject:
• Subject presenting with a serious systemic disease, which may lead to premature termination of the study before the end of the twelve weeks of treatment of the Follow up Period.
• Subject with a medical history or a significant disease revealed by history which can limit his/her participation or prevent the subject from completing the study.
• Subject presenting with a progressive neoplasm, treated with radiotherapy or chemotherapy or immunosuppressant therapy or high-dose corticosteroids.
• Subject with poorly controlled diabetes.
• Subject confined to bed.
• Woman of child-bearing potential (NOT postmenopausal for at least 24 months or NOT surgically sterilized (tubal ligation) or NOT hysterectomized) who is NOT routinely using adequate and efficient hormonal contraception or barrier method (intrauterine device, diaphragm, combination of condom and spermicide) prior to and during the trial.
• Subject with a history of allergic reaction(s) to one of the different components of the dressings or with a contra-indication to the use of one of these dressings.
• Known history of alcohol abuse or drug abuse.
• Subject linguistically or psychologically unable to understand the information given and to provide informed consent.

Sponsors & Collaborators

• Mylan Inc.: lead
• CEN Biotech: collaborator

Study Sites (27)

Research Facility ID ORG-001183

Angoulème, 16000, France

Location

Research Facility ID ORG-000857

Annecy, 74000, France

Location

Research facility ID ORG-000853

Asnières, 92600, France

Location

Research facility ID ORG-000981

Beaune, 21200, France

Location

Research Facility ID ORG-000844

Boulogne-sur-Mer, 62200, France

Location

Research Facility ID ORG-000869

Bourgoin, 38300, France

Location

Research facility ID ORG-001215

Brest, 29609, France

Location

Research Facility ID ORG-001181

Figeac, 46100, France

Location

Research facility ID ORG-001081

Grenoble, 38043, France

Location

Research Facility ID ORG-000850

Hazebrouck, 59190, France

Location

Research facility ID ORG-000855

Lattes, 34970, France

Location

Research Facility ID ORG-000859

Laxou, 54520, France

Location

Research Facility ID ORG-000830

Lyon, 69007, France

Location

Research facility ORG-001362

Melun, 77000, France

Location

Research Facility ID ORG-001182

Montpellier, 34000, France

Location

Research facility ID ORG-000836

Nancy, 54000, France

Location

Research facility ORG-001361

Nantes, 44093, France

Location

Research facility ID ORG-000831

Paris, 75019, France

Location

Research Facility ID ORG-000832

Paris, 75116, France

Location

Research facility ID ORG-000856

Pézenas, 34120, France

Location

Research facility ID ORG-001082

Saint-Aubin-sur-Scie, 76550, France

Location

Research facility ID ORG-000865

Saint-Maur, 94100, France

Location

Research facility ID ORG-000845

Tarare, 69170, France

Location

Research facility ID ORG-001216

Toulon, 83800, France

Location

Research facility ID ORG-001083

Toulouse, 31076, France

Location

Research Facility ID ORG-000862

Tours, 37000, France

Location

Research facility ID ORG-000835

Vincennes, 94300, France

Location

MeSH Terms

Conditions

Varicose Ulcer; Pain

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Benoit LA ROCHE
• Organization: Mylan Medical SAS

benoit.la-roche@mylan.com

+33 1 46 25 86 76

Study Officials

• Roger Lesaunier, MD

  Mylan Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: April 4, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 21, 2022
• Results First Posted: June 10, 2019

Record last verified: 2017-03

Locations

FR (27)