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

Wound Healing Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734317
• Other study ID #: MxT Ag 02
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Healing

Intervention

Device:
• Mepilex Transfer Ag
A soft silicone wound contact layer.

Locations

Country	Name	City	State
United States	Long Island Plastic Surgical Group, P.C	Garden City	New York
United States	Florida Gulf-to-bay Anesthesiology	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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