Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement

Study Overview
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Brief Summary
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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.

Official Title
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An Open, Single-arm, Multicentre and Interventional Investigation to Evaluate the Debriding Effect of ChloraSolv® on Pressure Ulcers in Need of Debridement

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Device: ChloraSolv


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pressure ulcer in need of debridement Male or female, 18 years of age and above 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: Known allergy/hypersensitivity to any of the components of ChloraSolv Pregnancy or breastfeeding Subjects included in other ongoing clinical investigations which could interfere with this investigation, as judged by the investigator 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 Wound requiring more than two (2) ChloraSolv syringes for one treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational device<br>ChloraSolv | Device: ChloraSolv<br>* Debridement with ChloraSolv until the wound is visually assessed as clean.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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. | 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) | 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. | 1-18 weeks | 
| Treatment period duration with ChloraSolv | Number of weeks that ChloraSolv was used | 1-12 weeks | 
| Number of treatments with ChloraSolv from Baseline until End of Treatment | Number of treatments with ChloraSolv until end of treatment | 1-12 weeks | 
| Incidence of subjects with complete wound healing during the investigation period | Number of patients receiving a healed wound | 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 | 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 | 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 | 1-12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pressure ulcer, Debridement, ChloraSolv