Management of Infection Risk in Non-comparative Trial (MINT)

NCT03670329 | Unknown

• 1 other identifier: F-08-07-AWC008
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The URGO2875 dressing is an innovative antimicrobial dressing made of exclusive technologies of TLC-Ag healing matrix and fibres. The dressing has been developed for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection. The purpose of this non-comparative clinical trial was to evaluate the performance (efficacy and safety) of the URGO2875 dressing, on the healing process of chronic wounds presenting a high-risk of infection.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (1)

• Wound surface area

  Relative wound surface area reduction (%) at the end of the four weeks of treatment

  4 weeks

Secondary Outcomes (5)

• Inflammatory clinical signs

  4 weeks

• Percentage of wounds with a favourable outcome

  4 weeks

• Time to healing

  4 weeks

• Healing

  4 weeks

• Patient quality of life

  4 weeks

Other Outcomes (1)

• Adverse event

  4 weeks

Study Arms (1)

URGO2875

EXPERIMENTAL

Dressing

Device: URGO2875

Interventions

URGO2875 DEVICE

Dressing

URGO2875

Eligibility Criteria

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

You may qualify if:

• Adult patient, aged ≥ 18 years, who signed and dated informed consent form,
• Patients affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.7 and ≤ 1.3),
• Patient willing and able to wear an effective venous compression system every day during the study period,
• Patient with at least three of the five inflammatory clinical signs : pain between dressing changes, periwound erythema, local oedema, malodour and presence of heavy exudate.

You may not qualify if:

• Patients under guardianship or protection of vulnerable adult
• Pregnancy or breastfeeding women,
• Childbearing potential women with no medically-acceptable method of birth control,
• Patients included in another clinical study,
• Patients with known allergy with hydrocolloid (carboxymethylcellulose CMC), silicone or silver,
• Patients with wound covered partially or totally with necrotic tissue,
• Patients with a serious general disease that deemed to interfere with the treatment period and evaluation
• Patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy or hormone therapy
• Patients with non-controlled systemic infection by an suitable antibiotic therapy
• Patients with clinically infected wound
• Patients with wound requiring surgical treatment or for which surgery is scheduled during the study period
• Patients with known cancerous lesions

Sponsors & Collaborators

• Laboratoires URGO: lead

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• GERI Ms Chloe, MD

  Lapeyronie Hospital, Montpellier- FRANCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

BATOT Ms Geraldine, PhD

CONTACT

+33 (0)3 80 44 28 46; g.batot@fr.urgo.com

TACCA Mr Olivier, PhD

CONTACT

+33 (0)3 80 44 74 22; o.tacca@fr.urgo.com

Study Design

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

Model Details: Non-comparative study

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 13, 2018
• Study Start: October 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share