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

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.

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.

Study Overview

• Status: Completed
• Conditions: Wound Healing
• Intervention / Treatment: Device: Mepilex Transfer Ag

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Florida Gulf-to-Bay Anesthesiology
  • New York
    • Garden City, New York, United States, 11530
      • Long Island Plastic Surgical Group, P.C

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dressing; Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.	Device: Mepilex Transfer Ag; A soft silicone wound contact layer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Wound Healing	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.	14 days and 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	After 0/14/21 days treatment

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Investigators: Principal Investigator: Hans Schweiger, MD, Florida Gulf-toBay Anesthesiology, Tampa Bay Circle

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: November 22, 2012
• First Submitted That Met QC Criteria: November 22, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 1, 2020
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: MxT Ag 02