A Clinical Investigation to Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement
Study Details
Study Description
Brief Summary
his 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Investigational device ChloraSolv |
Device: ChloraSolv
Debridement with ChloraSolv until the wound is visually assessed as clean.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Incidence of subjects with a clean wound bed at End of Treatment, as assessed by planimetry [1-12]
When the investigator judges that the wound is clean and this is confirmed by planimetry
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pressure ulcer in need of debridement
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Male or female, 18 years of age and above
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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:
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Known allergy/hypersensitivity to any of the components of ChloraSolv
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Pregnancy or breastfeeding
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Subjects included in other ongoing clinical investigations which could interfere with this investigation, as judged by the investigator
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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
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Wound requiring more than two (2) ChloraSolv syringes for one treatment
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dept of Orthopaedic Surgery | Mölndal | Sweden | 43180 |
Sponsors and Collaborators
- RLS Global
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PN-00041