NCT05547191

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: RLS Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	ChloraSolv	Debridement with ChloraSolv until the wound is visually assessed as clean.

Timeline

• Start date: 2023-09-01
• Primary completion: 2023-11-20
• Completion: 2023-11-20
• First posted: 2022-09-21
• Last updated: 2023-12-04

Locations

6 sites across 3 countries: Aland Islands, Sweden, United Kingdom