N/A
N=25
A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
Burn Injury · Skin Graft
Bottom Line
View on ClinicalTrials.gov: NCT02210208 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Part A: Number of Participants With Healing — 3; 21; 2; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mepitel® Ag (Device); Mepilex® Transfer Ag (Device)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Number of Participants With Healing |
3; 21; 2; 22 | — |
| PRIMARY Part B |
15; 3; 2; 4 | — |
| SECONDARY Part A Secondary Outcome. |
24; 20; 4; 22; 2; 16 | — |
| SECONDARY Part B Secondary Outcome. |
2; 16; 3; 2; 1; 6 | — |
Summary
Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn patients.
Part B The primary objective of Part B will be to examine the usefulness of Mepilex® Transfer Ag as an adequate option for donor site healing.
Eligibility Criteria
Part A
Inclusion Criteria
- Subjects with burn injury resulting in up to 30% TBSA
- Full thickness area of burn should not be more than 20%
- Area in need of skin grafting can be 1-15% TBSA
- Study site area must have healthy, intact peri-wound skin surrounding it to allow for adequate overlap of study product
- Thermal injuries only
- Subjects age 18 months to < 65 years.
- Signed informed consent
- Subjects who are younger than the legal consenting age must in addition to their own assent form have a signature from a legally authorized representative.
Exclusion Criteria
- Greater than 30% TBSA
- Full thickness areas greater than 20% TBSA
- Full thickness area to be grafted less than 1%
- Presence of respiratory involvement
- Subjects on mechanical ventilation
- Subjects with infected burn wounds
- Subjects with organ failure
- Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer and severe aeaemia) judged by the investigator to be a potential interference in the treatment
- Subjects treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone/day or equivalent
- Known allergy/hypersensitivity to any of the components of the investigation products.
- Subjects with physical and/or mental conditions that are not expected to comply with the investigation, including patients totally confined to bed
- Participation in other clinical investigation(s) within 1 month prior to start of the investigation
- Previous randomized to this investigation
Part B
Inclusion Criteria
-There must be healthy, intact peri-wound skin surrounding the planned donor site to allow for adequate overlap of study product (5 cm)
Exclusion Criteria
- Investigator do not agree to treat the donor site with Mepilex Transfer Ag
- The subject do not agree to participate in the donor site part
Data sourced from ClinicalTrials.gov (NCT02210208). 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.