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OpenTrials
Completed

NCT Number: NCT01573234

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ospedale Bellaria - UOC Dermatologia

Bologna, 40100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MySkin patch

Device

Hydrogel and polyurethane film

Gauze and Patch

Device

Traditional Dressing

Primary outcomes

  1. Wound healing

    Time frame: 1 month

  2. Patient's pain

    Time frame: 1 month

Secondary outcomes

  1. Clinical evaluation of the lesion scores for each visit

    Time frame: 1 month

  2. The presence / absence of infection for each visit

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Associazione Infermieristica per lo studio delle Lesioni Cutanee

Other

Collaborators

  • Artsana S.p.a.

Registry information

Official study title

Efficacy of MySkin Patch for the Healing of Cut Injuries and Abrasions: a Randomised Controlled Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Apr 9, 2012
Registry last updated
Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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