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OpenTrials
Completed

NCT Number: NCT01636362

A Clinical Investigation to Evaluate Efficacy of Mepitel Ag in Partial Thickness Second Degree Burns

Approximately 55-65 subjects from 3-6 sites suffering from a burn injury covering 1-25% Total Body Surface Area (TBSA) will be evaluated providing they fulfill all inclusion and none of the exclusion criteria and have given a signed and dated informed consent. Study site will be from 1-15%. Each subject will be followed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. All dressing changes will be performed at the clinic and gauze rolls will be used as secondary dressing. All dressing changes will be registered in a dressing log. All subjects will be consecutively allocated to a subject code.

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Key information

Conditions

Burns Wound Healing Wounds and Injuries

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Burn Center, Phoenix, Arizona, United States

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About this study

see Brief summary

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject with a partial-thickness (superficial, deep or mixed) second degree burn from 1-25% TBSA
  • Study site is from 1-15% BSA
  • Study site is a single, isolated burn area
  • From 2 years and above
  • Thermal burn injury
  • Signed Informed Consent/Assent Form
  • Subjects who are younger than the legal consenting age must in addition to their own Assent form have a signature from a legally authorized representative.

Exclusion criteria

  • Completely non-exuding or dry wound bed at study site
  • Full thickness >5%
  • Burn greater than 24 hrs old
  • Burns to face or neck
  • Suspicion of infection of study burn
  • Use of chemical/enzymatic and biological debridement within 7 days of investigation start
  • Chronic steroid use, hx of skin malignancy or chronic papulosquamous disease (e.g. eczema, Pemphigus) and hx of Steven Johnson or TENS disease
  • Subject with lung injury or subject being on a ventilator
  • Subject with dermatologic skin disorders or necrotizing processes
  • Subject with insulin dependent diabetes mellitus
  • Electrical, chemical etiology
  • Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe anaemia), judged by the investigator to be a potential interference in the treatment
  • Non-compliant subject
  • Subject previously included in this investigation
  • Subject included in other ongoing clinical investigation at present or during the past 30 days.

Treatment and study plan

Mepitel Ag

Device

Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.

Primary outcomes

  1. Number of Subjects Healed at Day 14.

    Time frame: Healing will be assessed after 14 days.

    > = 95 % epitheliazation

  2. Proportion of Subjects Healed at Day 21.

    Time frame: Healing will be assessed after 21 days.

    The proportion of subjects healed will be assessed at day 14. Wounds not healed at day 14 will be assessed again at day 21.

Secondary outcomes

  1. Percent of Study Burn Healed.

    Time frame: At day 21

    Percent of study burn healed measured by PictZar photo analysis of tissue types.

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study title

An Open, Non Controlled, Multi-centre, Clinical Investigation to Evaluate Efficacy in Partial Thickness (Superficial, Deep and Mixed) Second Degree Burns When Using a Soft Silicone, Silver Containing, Wound Contact Layer, Mepitel Ag.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 10, 2012
Registry last updated
Oct 7, 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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