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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Debridement with ChloraSolv until the wound is visually assessed as clean.
Kirurgkliniken, Ålands hälso- och sjukvård
Mariehamn, Åland, Aland Islands
Dept of Orthopaedic Surgery
Mölndal, Sweden
Buckinghamshire Healthcare NHS Trust
Aylesbury, England, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool, England, United Kingdom
East London NHS Foundation Trust
Newham, England, United Kingdom
Greater Glasgow Health Board
Glasgow, Scotland, United Kingdom
Incidence of subjects with a clean wound bed, not in need of further debridement at End of Treatment, as assessed by investigator
When the investigator judge that the wound is clean, primary endpoint is reached
Time frame: 1-12 weeks
Incidence of subjects with a clean wound bed at End of Treatment, as assessed by planimetry
When the investigator judges that the wound is clean and this is confirmed by planimetry
Time frame: 1-12 weeks
Relative change in devitalized tissue at End of Treatment and Follow-up, compared to Baseline, assessed by planimetry
Changes in devitalized tissue, measured by planimetry
Time frame: 1-18 weeks
Relative change in wound area at End of Treatment and Follow-up, compared to Baseline and End of Treatment, assessed by planimetry
Changes in wound area, measured by planimetry
Time frame: 1-18 weeks
Relative change in volume at End of Treatment and Follow-up, compared to Baseline and End of Treatment, assessed by planimetry
Changes in volume, measured by planimetry
Time frame: 1-18 weeks
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
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.
Time frame: 1-18 weeks
Pain during treatment compared to baseline using a Visual Analogue Scale
Changes in pain during treatment from baseline to End of Treatment. Minimum value=0 (No pain), Maximum value=100 (Worst imaginable pain)
Time frame: 1-12 weeks
Wound status i.e. clinical signs of infection at all visits
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.
Time frame: 1-18 weeks
Treatment period duration with ChloraSolv
Number of weeks that ChloraSolv was used
Time frame: 1-12 weeks
Number of treatments with ChloraSolv from Baseline until End of Treatment
Number of treatments with ChloraSolv until end of treatment
Time frame: 1-12 weeks
Incidence of subjects with complete wound healing during the investigation period
Number of patients receiving a healed wound
Time frame: 1-18 weeks
Incidence of subjects needing sharp debridement during the investigation period and compared to before start of the investigation
Usage of sharp (scalpel or knife) debridement during the investigation period
Time frame: 0-18 weeks
Answers from overall evaluation by site personnel
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
Time frame: Through study completion, an average of 1 year
Answers from overall evaluation by subjects
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
Time frame: 1-12 weeks
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