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

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Status and phase

Completed

Phase 3

Conditions

Cut Injuries

Wounds and Injuries

Abrasion

Treatments

Device: MySkin patch

Device: Gauze and Patch

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01573234

AISLeC-003

Details and patient eligibility

About

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).

Enrollment

180 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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