Pressure Ulcer
Conditions
Keywords
Pressure ulcer, Debridement, ChloraSolv
Brief summary
This is an open, single-arm, multicentre and interventional investigation to evaluate the debriding effect of ChloraSolv when used on pressure ulcers in need of debridement. Approximately 54 subjects will be enrolled to have 47 evaluable subjects (calculated dropout range 15%). ChloraSolv will be applied 1-2 times per week for 12 weeks or until the wound is deemed clean, whichever occurs first i.e. End of Treatment. A Follow-up visit for wound status evaluation will be performed 6 weeks from End of Treatment. Total time in investigation will be maximum 12+6 weeks. Subjects will attend a baseline visit to assess eligibility and collect demographic and baseline data and initiate treatment. Photographs of the wound pre and post debridement will be taken at baseline, every week during the treatment period, at End of Treatment and at the Follow-up visit. Photographs will be used to calculate (by PictZar digital planimetry system) the area of devitalized tissue in the wound as well as wound size and calculation of volume. Wound depth and undermining will be estimated by the investigator at all investigational visits. A treatment diary will be used in-between the weekly investigational visits to collect any further treatments. The treatment diary will also be filled-in during the follow-up period of 6 weeks.
Interventions
DEVICEChloraSolv
Debridement with ChloraSolv until the wound is visually assessed as clean.
Sponsors
RLS Global
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pressure ulcer in need of debridement 2. Male or female, 18 years of age and above 3. Able to read and understand the Patient Informed Consent and to provide written informed consent. If written consent is not possible due to the condition of the patient, one impartial witness shall sign and date the informed consent.
Exclusion criteria
1. Known allergy/hypersensitivity to any of the components of ChloraSolv 2. Pregnancy or breastfeeding 3. Subjects included in other ongoing clinical investigations which could interfere with this investigation, as judged by the investigator 4. Subjects not suitable for the investigation according to the investigator's judgment or other significant medical conditions that the investigator determines could interfere with compliance or investigation assessments 5. Wound requiring more than two (2) ChloraSolv syringes for one treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of subjects with a clean wound bed, not in need of further debridement at End of Treatment, as assessed by investigator | 1-12 weeks | When the investigator judge that the wound is clean, primary endpoint is reached |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of subjects with a clean wound bed at End of Treatment, as assessed by planimetry | 1-12 weeks | When the investigator judges that the wound is clean and this is confirmed by planimetry |
| Relative change in devitalized tissue at End of Treatment and Follow-up, compared to Baseline, assessed by planimetry | 1-18 weeks | Changes in devitalized tissue, measured by planimetry |
| Relative change in wound area at End of Treatment and Follow-up, compared to Baseline and End of Treatment, assessed by planimetry | 1-18 weeks | Changes in wound area, measured by planimetry |
| Relative change in volume at End of Treatment and Follow-up, compared to Baseline and End of Treatment, assessed by planimetry | 1-18 weeks | Changes in volume, measured by planimetry |
| Relative change in wound depth and undermining at End of Treatment and Follow-up, compared to Baseline, assessed by investigator by using a sterile cotton-tipped applicator | 1-18 weeks | Changes in wound depth (mm) and undermining (mm) will be measured by site personnel using a sterile cotton-tipped applicator and read against a wound ruler. |
| Pain during treatment compared to baseline using a Visual Analogue Scale | 1-12 weeks | Changes in pain during treatment from baseline to End of Treatment. Minimum value=0 (No pain), Maximum value=100 (Worst imaginable pain) |
| Treatment period duration with ChloraSolv | 1-12 weeks | Number of weeks that ChloraSolv was used |
| Number of treatments with ChloraSolv from Baseline until End of Treatment | 1-12 weeks | Number of treatments with ChloraSolv until end of treatment |
| Incidence of subjects with complete wound healing during the investigation period | 1-18 weeks | Number of patients receiving a healed wound |
| Incidence of subjects needing sharp debridement during the investigation period and compared to before start of the investigation | 0-18 weeks | Usage of sharp (scalpel or knife) debridement during the investigation period |
| Answers from overall evaluation by site personnel | Through study completion, an average of 1 year | A questionnaire consisting of 5 questions (evaluating the handling/usage of the investigational device) will be filled in by site personnel at end of investigation. There will be four alternatives; Very easy/Easy/Difficult/Very difficult |
| Answers from overall evaluation by subjects | 1-12 weeks | The subjects will be asked to answer four questions (overall experience with the investigational device) at end of treatment. There will be four alternatives; Very good/Good/Bad/Very Bad |
| Wound status i.e. clinical signs of infection at all visits | 1-18 weeks | Clinical signs of infection will be documented by ticking off a list with five alternatives/symptoms (redness, heat, edema, pain and odour).Three or more symptoms will be assessed as the subject having clinical signs of infection. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency, severity, device relationship and outcome of all adverse events | 0-18 weeks | Collection of adverse events to evaluate safety |
Countries
Aland Islands, Sweden, United Kingdom
Outcome results
None listed