Phase 4
N=43
Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts
Deep Partial Thickness Burn · Full Thickness Burns
Bottom Line
View on ClinicalTrials.gov: NCT01365273 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: VAS Score for Pain Before Dressing Removal — 11.0; 4.0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mepitel One (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VAS Score for Pain Before Dressing Removal |
11.0; 4.0 | — |
| PRIMARY VAS Score for Pain During Dressing Removal |
44.0; 4.0 | — |
| PRIMARY VAS Score for Pain After Dressing Removal |
21.0; 3.0 | — |
Summary
This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5 centres in the US with deep-partial of full thickness burns in need of skin grafts will be enrolled.The subjects will be equally randomised to either treatment with Mepitel One or bridal veil together with staples.
The primary objective is to compare pain at the time of dressing change for the use of Mepitel One versus bridal veil together with staples on deep partial or full thickness burns requiring skin grafts.
Eligibility Criteria
Inclusion Criteria
- Inclusion Criteria
- Subjects presenting with 1% - 25% Total Body Surface Area (TBSA) deep partial or full-thickness burns requiring skin graft
- At least 1%-10% TBSA is available for grafting that can be considered for study site selection (must have intact, healthy peri-wound area around entire portion of this burned site)
- Both genders with age ≥18 years but < 70 years
- Signed informed consent
Exclusion Criteria
- Subjects with chronic wounds
- Subjects who are on mechanical ventilation
- Subjects with dermatologic skin conditions or necrotizing disorders
- Diagnosed underlying disease(s) (HIV/AIDS, cancer and severe anaemia)judged by the investigator to be a potential interference in the treatment
- Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10 mg prednisolon/day or equivalent
- Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
- Known allergy/hypersensitivity to any of the components of the investigational products
- Subjects with physical and/or mental conditions that are not expected to comply with the investigation
- Participation in other clinical investigation(s) within 1 month prior to start of the investigation
- Previously randomised to this investigation
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01365273). 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.