chronic wound - wound infection
Conditions
Interventions
After cleaning the wound, a (para)medical professional applies a PLASOMA
treatment of two minutes.
The PLASOMA treatment takes maximum 12 weeks with a treatment frequency of
maximum once per day a
Sponsors
Plasmacure
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: INCL1: have a slow-healing or non-healing ulcer consisting of, but not limited to diabetic ulcers, venous ulcers, pressure ulcers, burn wounds, skin grafts and flaps and infected post-surgical ulcers. Standard wound care has not resulted in sufficient healing after at least two weeks (including first line care). Note: There is no upper limit for the duration that the wound exists. In case a subject has multiple wounds that meet the in- and exclusion criteria, the wound with the longest duration will be chosen for the study. INCL2: have a wound with a minimum wound surface area of 0.5 cm2 and a maximum diameter of 4.5 cm (~16 cm2 wound surface area for circular wounds). INCL3: have a minimum age of 18 years old. INCL4: for home care treatments only: have a grounded wall socket available for connection of PLASOMA.
Exclusion criteria
Exclusion criteria: EXCL1: the subject has one or more of the following contraindications for PLASOMA: • the wound is very exudative, i.e. wounds in which moisture is visible again within a few minutes after patting dry. • any implanted active electronic device, such as a pacemaker, is present. • an electronic medical device is attached to the body, including electronic life support equipment, hearing aids, glucose sensors and insulin pumps. If the sole purpose of the medical device is monitoring, the subject is not excluded, but it should be noted that use of PLASOMA together with such devices has not been tested and may lead to erroneous operation of the attached device during PLASOMA treatment. Note: no exclusion if electronic medical device will be detached during PLASOMA treatment. • a metal implant (including a stent) is present in the treatment area, i.e. the area between pad and electrode. • a conductive connection from outside to inside the body at or near the heart is present, e.g. a catheter with electrolyte fluid. • the subject has epilepsy • the subject is pregnant • the to-be-treated wound is located on the torso above the navel EXCL2: the subject has any known malignant wound degeneration. EXCL3: the subject receives treatment with immunosuppressive agents or oral corticosteroids; no exclusion if subject has received a stable dose for at least 2 months and the oral corticosteroid dose does not exceed 7.5 mg/day prednisone or equivalent. EXCL4: the subject is receiving or likely to receive advanced wound therapies - such as negative pressure therapy, hyperbaric oxygen therapy, biologicals (e.g. skin substitutes, growth factors), electrophysical therapy - until FU1 for the to be-treated wound. Advanced wound dressings are not excluded. EXCL5: the subject participates in another study which is likely to compromise the outcome of the PULSE study or the feasibility of the subject fulfilling the PULSE study. EXCL6: the subject is unable to provide consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objectives/outcomes of this study: 1. To evaluate the safety of the PLASOMA by analysing the number and type of device related SAEs, including long term (12 months) follow up. 2. To evaluate* the efficacy of the PLASOMA by measuring the reduction in number of Staphylococcus aureus colonies. This will be done during the frist treatment only. 3. To evaluate* the efficacy of the PLASOMA by measuring the % wound surface area reduction after 12 weeks of treatment. *) This will be done by comparing the treatment group with the control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives/outcomes of this study: 1. To evaluate* the safety of the PLASOMA by comparing the number and type of all (serious) adverse events ((S)AEs) in the treatment group with those in the control group, including long term (12 monhts) follow up. 2. To evaluate* the safety of the PLASOMA by assessing (until FU2) a. % Wound surface area reduction b. Wound appearance 3. To evaluate* the efficacy of the PLASOMA by measuring the bacterial load reduction. This will be done during the first treatment only: a. Pseudomonas aeruginosa b. Total bacterial load 4. To evaluate* the efficacy of the PLASOMA by measuring the wound healing: a. % Wound healing after 4 weeks of treatment b. % Wound healing after 12 weeks of treatment c. Time to healing (until 12 weeks) d. % Wounds with wound surface area reduction >=50% after 4 weeks of treatment e. % Wound surface area reduction after 4 weeks of treatment f. % Wound volume reduction after 4 weeks of treatment g. % Wound volume reduction after 12 weeks of treatment 5. To evaluate* the efficacy of the PLASOMA by assessing a. Number of recurrences b. Quality of life c. Wound pain d. Wound infection 6. Health Technology Assessment 7. Patient acceptability of PLASOMA treatment *) This will be done by comparing the treatment group with the control group. | — |
Countries
Netherlands
Outcome results
None listed