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

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

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 Overview

• Status: Terminated
• Conditions: Pressure Ulcer
• Intervention / Treatment: Device: ChloraSolv

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Aland Islands
  • Åland
    • Mariehamn, Åland, Aland Islands, 22111
      • Kirurgkliniken, Ålands hälso- och sjukvård
• Sweden
  • Mölndal, Sweden, 43180
    • Dept of Orthopaedic Surgery
• United Kingdom
  • England
    • Aylesbury, England, United Kingdom, HP21 8AL
      • Buckinghamshire Healthcare NHS Trust
    • Liverpool, England, United Kingdom, L7 8XP
      • Liverpool University Hospitals NHS Foundation Trust
    • Newham, England, United Kingdom, E18DE
      • East London NHS Foundation Trust
  • Scotland
    • Glasgow, Scotland, United Kingdom, G12 OXH
      • Greater Glasgow Health Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational device; ChloraSolv	Device: ChloraSolv; Debridement with ChloraSolv until the wound is visually assessed as clean.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency, severity, device relationship and outcome of all adverse events	Collection of adverse events to evaluate safety	0-18 weeks

Collaborators and Investigators

• Sponsor: RLS Global

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): November 20, 2023
• Study Completion (Actual): November 20, 2023

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Pressure ulcer; Debridement; ChloraSolv
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Pressure Ulcer
• Other Study ID Numbers: PN-00041; 320237 (Registry Identifier: IRAS Integrated Research Application System)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No