Pressure Ulcer
Conditions
Keywords
melatonin, ischemia
Brief summary
Melatonin has been shown to prevent cellular damage produced by oxidative stress or in situations of ischaemia, inhibiting the synthesis of oxidants and pro inflammatory factors such as pro-inflammatory cytokines, substances which are present in pressure ulcers and can affect the healing process, slowing it down. Melatonin gel has also been shown to prevent ulcers in the oral mucosa due to radiotherapy. Therefore, the hypothesis for this study is that the melatonin cream provides greater ulcer area reduction than standard pressure ulcer treatment.
Detailed description
Melatonin has been shown to prevent cellular damage produced by oxidative stress or in situations of ischaemia, inhibiting the synthesis of oxidants and pro inflammatory factors such as pro-inflammatory cytokines, substances which are present in pressure ulcers and can affect the healing process, slowing it down. Melatonin gel has also been shown to prevent ulcers in the oral mucosa due to radiotherapy. Therefore, the hypothesis for this study is that the melatonin cream provides greater ulcer area reduction than standard pressure ulcer treatment. In order to o determine the efficacy of melatonin in healing pressure ulcer it has been designed a multicentre, single-blind, randomized clinical trial comparing melatonin cream as an experimental pressure ulcer treatment versus control group with standard treatment based on moist environment wound healing with a time frame of 8 weeks. In order to assess the healing rate, changes in Resvech 2.0 scale scores will be measured, as well as the ulcer surface reduction. To avoid variability in measuring ulcer surface, it will be done by using software HELCOS after taking a photograph of the wound weekly. An intention-to-treat analysis will be carried out. The t-test or Mann-Whitney will be used to check difference of means in the reduction of the area of the ulcer and variation in the Resvech 2.0 scale. Survival curves will be used to check possible differences in the follow-up time until epithelization.
Interventions
DRUGHydrogel
Pressure ulcer will be treated with hydrogel daily as a comparator
DRUGMelatonin
Pressure Ulcer will be treated with a melatonin cream daily
Sponsors
Pharmamel S.L.
Universidad de Granada
Instituto de Salud Carlos III
Fundacion Rioja Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Present at least one category II, III or IV pressure ulcer according to National Group for the Study and Assessment of Pressure Ulcers (GNEAUPP) classification. * Ulcer area between 1 and 100 cm2. * People over 18 years of age who have freely given their informed consent in writing of their own volition or it has been given on their behalf by a legal guardian
Exclusion criteria
* Ulcer of category I, non-classifiable or affecting internal tissues, but with no break in the skin * People currently undergoing chemotherapy treatment or who have done so in the previous 6 months * People with a presumed life expectancy of less than 6 months or in palliative care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epithelialisation | Up to 8 weeks | Percentage of completely epithelialized ulcers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pressure ulcer area | Up to 8 weeks | Percentage of reduction in pressure ulcer area |
Contacts
Primary ContactMarco Aldonza-Torres
Outcome results
None listed