Clinical trial NCT05547191: Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement
Official title: An Open, Single-arm, Multicentre and Interventional Investigation to Evaluate the Debriding Effect of ChloraSolv® on Pressure Ulcers in Need of Debridement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pressure Ulcer
Keywords: Pressure ulcer
Debridement
ChloraSolv
Lead sponsor: RLS Global
Sponsor class: INDUSTRY
First posted: 2022-09-21
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of subjects with a clean wound bed, not in need of further debridement at End of Treatment, as assessed by investigator
timeFrame: 1-12 weeks
Secondary outcomes:
measure: Incidence of subjects with a clean wound bed at End of Treatment, as assessed by planimetry
timeFrame: 1-12 weeks
measure: Relative change in devitalized tissue at End of Treatment and Follow-up, compared to Baseline, assessed by planimetry
timeFrame: 1-18 weeks
measure: Relative change in wound area at End of Treatment and Follow-up, compared to Baseline and End of Treatment, assessed by planimetry
timeFrame: 1-18 weeks
measure: Relative change in volume at End of Treatment and Follow-up, compared to Baseline and End of Treatment, assessed by planimetry
timeFrame: 1-18 weeks
measure: 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
timeFrame: 1-18 weeks
measure: Pain during treatment compared to baseline using a Visual Analogue Scale
timeFrame: 1-12 weeks
measure: Wound status i.e. clinical signs of infection at all visits
timeFrame: 1-18 weeks
measure: Treatment period duration with ChloraSolv
timeFrame: 1-12 weeks
measure: Number of treatments with ChloraSolv from Baseline until End of Treatment
timeFrame: 1-12 weeks
measure: Incidence of subjects with complete wound healing during the investigation period
timeFrame: 1-18 weeks
measure: Incidence of subjects needing sharp debridement during the investigation period and compared to before start of the investigation
timeFrame: 0-18 weeks
measure: Answers from overall evaluation by site personnel
timeFrame: Through study completion, an average of 1 year
measure: Answers from overall evaluation by subjects
timeFrame: 1-12 weeks
Other outcomes:
measure: Frequency, severity, device relationship and outcome of all adverse events
timeFrame: 0-18 weeks
Locations:
city: Mariehamn
country: Aland Islands
facility: Kirurgkliniken, Ålands hälso- och sjukvård
state: Åland
city: Mölndal
country: Sweden
facility: Dept of Orthopaedic Surgery
city: Aylesbury
country: United Kingdom
facility: Buckinghamshire Healthcare NHS Trust
state: England
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
state: England
city: Newham
country: United Kingdom
facility: East London NHS Foundation Trust
state: England
city: Glasgow
country: United Kingdom
facility: Greater Glasgow Health Board
state: Scotland
Study officials:
References: