EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers (RISE_UP)
Pressure Sore, Pressure Ulcer, Pressure Ulcers Stage III
About this trial
This is an interventional treatment trial for Pressure Sore focused on measuring ulcer, pressure ulcer, pressure sore, blue light, wound healing, EmoLED, photobiomodulation, LED
Eligibility Criteria
Inclusion Criteria:
- Patients with 2° or 3° stage lower limb/ sacrum located pressure ulcers;
- Patients with 2° or 3° stage pressure ulcers with a ≥ 2cm² lesion area;
- Patients with a hospitalization waiting time < 30 day;
- Men and women aged ≥ 50 years;
- Patients with a Braden scale score ≥ 11;
Exclusion Criteria:
- Patients who are participating in other clinical trials with drug or medical device;
- Patients with third stage pressure lesions, on the lower limbs or on the sacrum, with undermining wounds, tunneling or eschar;
- Patients with systemic or superficial infection at the time of recruitment, that need systemic antibiotic therapy;
- Patients with a history of self-harm who can voluntarily alter the course of healing;
- Patients under intravenous therapy with doses of corticosteroids above 40mg/day;
- Patients under immunosuppressant or cytostatic drugs therapy;
- Women who are pregnant or breastfeeding1;
- Patients with neoplasia;
- Patients with pathologies that induce skin photosensitivity;
- Patients with a life expectancy of less than 30 days.
Sites / Locations
- IRCCS Don Carlo GnocchiRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Control Group
EmoLED Group
The Control Group will follow the standard treatment indicated three times a week for the 4 weeks of observation. The standard treatment for 2° and 3° stage PU consists of: cleansing with saline or ringer's lactate, hyaluronic acid gauze plus polyurethane foam every 48 hours or as needed. In addition, zinc cream or hyaluronic acid sodium salt + metallic silver is applied to prevent and/or treat the skin maceration of the surrounding area, and eventual debridement of the lesion, application of topical treatment indicated for that stage of the lesion (as provided by the "Protocol on pressure ulcers' dressing" intended as the "standard of care" of the structure) and subsequent bandage (that generally consists of a polyurethane film -thin hydrocolloid plate or a pressure discharge system made with hydrocolloids and polyurethane foam, known as "pressure relief system"), are planned.
The Experimental Group will undergo, in addition to the standard treatment, treatment with Emoled three times a week for 4 consecutive weeks. This treatment consists of irradiation with the blue light emitted by the device for one minute on the injured area. If the lesion has a greater extension than the irradiated area, multiple repeated applications will be performed, on adjacent areas, until the entire area is covered. The treatment with EmoLED will be carried out in correspondence with the dressing change of the lesion.