Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions

NCT01573234 | Completed Phase 3 DMC

• 1 other identifier: AISLeC-003
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of clinical efficacy of My Skin (hydrogel and polyurethane film) plus best practice clinical care in subjects with cut injuries and abrasions with particular regard to: Wound healing (complete reepithelialization) and patient's pain. In the context of the study will be collected secondary outcomes related to type of lesion and its clinical evolution through the analysis of the items in the scale of the Pressure Sore Status Tool(PSST).

Conditions

Wounds and Injuries; Abrasion; Cut Injuries

Keywords

MySkin patch; Hydrogel bandage; Occlusive dressing

Outcome Measures

Primary Outcomes (2)

• Wound healing

  1 month

• Patient's pain

  1 month

Secondary Outcomes (2)

• Clinical evaluation of the lesion scores for each visit

  1 month

• The presence / absence of infection for each visit

  1 month

Study Arms (2)

MySkin patch

EXPERIMENTAL

Hydrogel and polyurethane film

Device: MySkin patch

Traditional Dressing

ACTIVE COMPARATOR

Device: Gauze and Patch

Interventions

MySkin patch DEVICE

Hydrogel and polyurethane film

MySkin patch

Gauze and Patch DEVICE

Traditional Dressing

Traditional Dressing

Eligibility Criteria

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

You may qualify if:

• Presence of at least an injury cut or abrasion (even if sutured)covered by a dressing of 10x8 cm (80 cm2)
• Injury treated with conventional dressings type gauze and patch
• Patients assisted at the emergency care, or at the outpatient
• Extension of the lesion less than 80 cm2 (including dressings in cm10x8cm)
• Patient age greater than or equal to 18 years
• Patients who have given consent to enrollment in the trial and the processing of personal data
• Patient / lesion that has already been recruited in the study or who have previously passed a period of 10 days (wash-out) of "no treatment" according to the research protocol

You may not qualify if:

• A end-stage of disease
• Subjected systemic corticosteroid therapy / radiotherapy / immunosuppressive therapy
• Suspected or known allergic diathesis to the product of medication
• Subjects that do not give consent to data processing
• Dry lesion with necrosis or eschar
• Presence of both local and systemic infection or inflammation
• Injuries that to the decision of the provider of care, needs a targeted local treatment other than as provided for in the Protocol
• Patient / lesion that has already been previously recruited into the study, before a period of 10 days (wash-out) of suspension from the same research protocol

Sponsors & Collaborators

• Associazione Infermieristica per lo studio delle Lesioni Cutanee: lead
• Artsana S.p.a.: collaborator

Study Sites (1)

Ospedale Bellaria - UOC Dermatologia

Bologna, Bologna, 40100, Italy

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Transdermal Patch

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Tommaso Bianchi

  Associazione Infermieristica per lo studio delle Lesioni Cutanee

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 9, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

IT (1)