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Completed

NCT Number: NCT01734317

An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver.

Approximately 10 subjects from one clinic having sustained a burn injury covering 1-25% or the Total Body surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial-thickness. The subject will be assessed once a week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. . The dressing Mepilex Transfer Ag will be used as wound contact layer and gauze rolls and compression as second dressing.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida Gulf-to-bay Anesthesiology, Tampa, Florida, United States

Loading trial locations.

About this study

Approximately 10 subjects from one site will be evaluated provided they fulfill the inclusion criteria and none of the exclusion criteria and gives a signed and dated consent.

Subjects may have sustained a burn injury covering 1-25% of the Total Body Surface Area (TBSA)and assessed as superficial partial-thickness or superficial deep-partial thickness in dept. Each subject will be followed one time per week for a maximum of 3 weeks or until the burn is healed if that occurs earlier. Healing is defined as ≥95% epithelialisation. Percent (%) healed epithelialization will be measured by photo analysing using the PictZar program. Dressing changes will be performed at each visit and in between if deemed necessary by the investigator.Gauze rolls and compression will be used as secondary dressing.All dressing changes will be registered in a log. Pain before, during and after removal will be assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject with a second degree (superficial, deep or mixed) partial thickness burn from 1-25% TBSA.
  • One single, isolated burn area selected for study site Study site area should be between 1-15% BSA
  • Male or female
  • From 18 years and above
  • Either in- or out-patient
  • Thermal burn injury
  • Signed Informed Consent/Assent Form

Exclusion criteria

  • Electrical, chemical burn etiology
  • If any full thickness areas are present, these should not be > 5 %
  • Burn greater than 36 hrs old
  • Burns to face
  • Use of chemical/enzymatic and biological debridement within 7 days of investigation start
  • Presence of inflammation or infection in burn wounds
  • Use of topical antibiotics, antiseptics, or antimicrobials in conjunction with study product.
  • Subjects with lung injury or Subject being on a ventilator
  • Subjects with dermatologic skin disorders or necrotizing processes
  • Subjects with insulin dependent diabetes mellitus judged by the investigator to be a potential interference in the treatment
  • Diagnosed underlying disease(s) (e.g HIV/AIDS, cancer and severe anaemia) judged by the investigator to be a potential interference in the treatment
  • Subject not expected to follow the investigation procedures
  • Subjects previously included in this investigation
  • Subjects included in other ongoing clinical investigation at present or during the past 30 days

Treatment and study plan

Mepilex Transfer Ag

Device

A soft silicone wound contact layer.

Primary outcomes

  1. Number of Participants With Wound Healing

    Time frame: 14 days and 21 days

    Healing at day 14 pt 21. Healing was defined as ≥95% epithelialisation. The PictZar program will be used to analyze burn wound healing by tissue type. ("The PictZar equipment for this analysis will be located at MHC HQ, however, the analysis will be performed by a clinician not affiliated with MHC.") Each subject was followed/assessed one time per week for a maximum of 3 weeks or until the burn was healed if that occured earlier.

Secondary outcomes

  1. Baseline (Visit 1) Pain Will be Measured Before Burn Assessment Visit 2-3, Pain Will be Measured (Pain BEFORE Dressing Removal, DURING Dressing Removal, AFTER Dressing Removal, 30 Min After Removal

    Time frame: After 0/14/21 days treatment

    Pain will be measured by using the VAS scale, by placing a vertical mark across the 100 mm long horizontal line, from No pain to the left to Most intense pain imaginable to the right.

    Baseline (Visit 1) Pain will be measured before burn assessment Visit 2-4, Pain will be measured (Pain BEFORE dressing removal, DURING dressing removal, AFTER dressing removal, 30 min after removal

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study title

An Open, Non Controled, Single-centre, Clinical Investigation to Evaluate Efficacy in Second Degree (Superficial, Deep or Mixed) Partial Thickness Burns When Using a Soft Silicone Wound Contact Ayer Containing Silver.

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 27, 2012
Registry last updated
Apr 3, 2020

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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