Deep Partial Thickness Burn, Full Thickness Burns
Conditions
Keywords
Split thickness skin grafts, Mepitel One, Bridal Veil and staples, Pain
Brief 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.
Detailed description
Skin grafts are placed over excised areas of full thickness injuries and usually attached with sutures or staples. While useful in anchoring the graft in place, subjects often complain of pain from the staples as wound healing progresses.Pulling and sticking are common complaints.There is also a possibility that staples become embedded in the graft which leads to disruption of otherwise healed area, increased pain and anxiety for the subject as well as anxiety for the staff. Graft take can be optimized with appropriate medical management. Use of non-adherent dressings to protect the graft is customary. Various types of netting-style are used, such as Bridal veil, a sterile product which is fixed over the graft with staples. Silicone net dressings have also been used successfully to prevent lifting and adherence of skin grafts to the dressings, prevent pain and promote healing. Mepitel One is a sterile, transparent, and flexible wound contact layer consisting of perforated polyurethane film coated with Safetac soft silicone adhesive on one side. Mepitel One is available in various sizes and can be left in place for several days depending on the wound/skin condition. Evaluation of burns will be performed at Baseline. Skin graft assessment will be performed at Day 7 and Day 14. End of study will be considered the time that graft is considered to have \>95% take.
Interventions
DEVICEMepitel One
Dressing
Sponsors
Molnlycke Health Care AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria 1. Subjects presenting with 1% - 25% Total Body Surface Area (TBSA) deep partial or full-thickness burns requiring skin graft 2. 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) 3. Both genders with age ≥18 years but \< 70 years 4. Signed informed consent
Exclusion criteria
1. Subjects with chronic wounds 2. Subjects who are on mechanical ventilation 3. Subjects with dermatologic skin conditions or necrotizing disorders 4. Diagnosed underlying disease(s) (HIV/AIDS, cancer and severe anaemia)judged by the investigator to be a potential interference in the treatment 5. Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10 mg prednisolon/day or equivalent 6. Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days 7. Known allergy/hypersensitivity to any of the components of the investigational products 8. Subjects with physical and/or mental conditions that are not expected to comply with the investigation 9. Participation in other clinical investigation(s) within 1 month prior to start of the investigation 10. Previously randomised to this investigation 11. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS Score for Pain Before Dressing Removal | At visit 6, day 7 | Pain was measured with Visual Analogue Scale (VAS)(100 mm) measuring from 0 = no pain at one end to 100 = most intense pain imagaginable at the other end. |
| VAS Score for Pain During Dressing Removal | Visit 6, day 7 | Pain when half of the study product(s) has been removed measued with Visual Analogue Scale (VAS).0 = no pain till 100 = worst pain. |
| VAS Score for Pain After Dressing Removal | Visit 6, day 7 | Pain after the dressing removal measued with Visual Analogue Scale (VAS).0 = no pain till 100 = worst pain. |
Countries
United States
Participant flow
Recruitment details
Date of first patient included: 26 April 2011 Date of last patient completed: 01 December 2011
Participants by arm
| Arm | Count |
|---|---|
| Bridal Veil and Staples Bridal Veil and staples are standard of care I | 22 |
| Mepitel One Device | 21 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Bridal Veil and Staples | Mepitel One | Total |
|---|---|---|---|
| Age, Continuous | 42.3 years STANDARD_DEVIATION 16 | 38.0 years STANDARD_DEVIATION 18 | 40.15 years STANDARD_DEVIATION 17 |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Male | 19 Participants | 16 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 |
Outcome results
Primary
VAS Score for Pain After Dressing Removal
Pain after the dressing removal measued with Visual Analogue Scale (VAS).0 = no pain till 100 = worst pain.
Time frame: Visit 6, day 7
Population: All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Bridal Veil and Staples | VAS Score for Pain After Dressing Removal | 21.0 units on a scale | Standard Deviation 34.7 |
| Mepitel One | VAS Score for Pain After Dressing Removal | 3.0 units on a scale | Standard Deviation 21.1 |
Primary
VAS Score for Pain Before Dressing Removal
Pain was measured with Visual Analogue Scale (VAS)(100 mm) measuring from 0 = no pain at one end to 100 = most intense pain imagaginable at the other end.
Time frame: At visit 6, day 7
Population: All subjects to post-randomization treatment and that provided some data for the primary endpoint were included in the ITT analysis.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Bridal Veil and Staples | VAS Score for Pain Before Dressing Removal | 11.0 units on a scale | Standard Deviation 21 |
| Mepitel One | VAS Score for Pain Before Dressing Removal | 4.0 units on a scale | Standard Deviation 20.1 |
Primary
VAS Score for Pain During Dressing Removal
Pain when half of the study product(s) has been removed measued with Visual Analogue Scale (VAS).0 = no pain till 100 = worst pain.
Time frame: Visit 6, day 7
Population: All included subjects to post-randomization treatment and that provided some data for the primary endpoint was included in the Intention To Treat analyses.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Bridal Veil and Staples | VAS Score for Pain During Dressing Removal | 44.0 units on a scale | Standard Deviation 28.6 |
| Mepitel One | VAS Score for Pain During Dressing Removal | 4.0 units on a scale | Standard Deviation 21.4 |