Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement
NCT ID: NCT05547191
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2023-09-01
2023-11-20
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Investigational device
ChloraSolv
ChloraSolv
Debridement with ChloraSolv until the wound is visually assessed as clean.
Interventions
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ChloraSolv
Debridement with ChloraSolv until the wound is visually assessed as clean.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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RLS Global
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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320237
Identifier Type: REGISTRY
Identifier Source: secondary_id
PN-00041
Identifier Type: -
Identifier Source: org_study_id