N/A
N=10
An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver.
Wound Healing
Bottom Line
View on ClinicalTrials.gov: NCT01734317 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Number of Participants With Wound Healing — 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mepilex Transfer Ag (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Wound Healing |
10 | — |
| 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 |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01734317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.