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

NCT05547191 | Terminated

• 2 other identifiers: PN-00041320237
• Study Type: interventional
• Target: 5
• Locations: 3 countries
• Sites: 6

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.

Conditions

Pressure Ulcer

Keywords

Pressure ulcer; Debridement; ChloraSolv

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Incidence of subjects with a clean wound bed at End of Treatment, as assessed by planimetry

  1-12 weeks

• Relative change in devitalized tissue at End of Treatment and Follow-up, compared to Baseline, assessed 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

  1-18 weeks

• Relative change in volume at End of Treatment and Follow-up, compared to Baseline and End of Treatment, assessed 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

  1-18 weeks

Other Outcomes (1)

• Frequency, severity, device relationship and outcome of all adverse events

  0-18 weeks

Study Arms (1)

Investigational device

EXPERIMENTAL

ChloraSolv

Device: ChloraSolv

Interventions

ChloraSolv DEVICE

Debridement with ChloraSolv until the wound is visually assessed as clean.

Investigational device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RLS Global: lead

Study Sites (6)

Kirurgkliniken, Ålands hälso- och sjukvård

Mariehamn, Åland, 22111, Aland Islands

Location

Dept of Orthopaedic Surgery

Mölndal, 43180, Sweden

Location

Buckinghamshire Healthcare NHS Trust

Aylesbury, England, HP21 8AL, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust

Liverpool, England, L7 8XP, United Kingdom

Location

East London NHS Foundation Trust

Newham, England, E18DE, United Kingdom

Location

Greater Glasgow Health Board

Glasgow, Scotland, G12 OXH, United Kingdom

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 21, 2022
• Study Start: September 1, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-09

Locations

AL (1); SE (1); GB (4)