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

NCT ID: NCT01734317

Last Updated: 2020-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-02-28

Brief Summary

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.

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.

Conditions

Wound Healing

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mepilex Transfer Ag

Intervention Type: DEVICE

A soft silicone wound contact layer.

Interventions

Mepilex Transfer Ag

A soft silicone wound contact layer.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Molnlycke Health Care AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans Schweiger, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Gulf-toBay Anesthesiology, Tampa Bay Circle

Locations

Florida Gulf-to-bay Anesthesiology

Tampa, Florida, United States

Long Island Plastic Surgical Group, P.C

Garden City, New York, United States

Countries

United States

Other Identifiers

MxT Ag 02

Identifier Type: -

Identifier Source: org_study_id