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

RLS Global

Status: Terminated

Conditions: Pressure Ulcer

Treatments: Device: ChloraSolv

Study type: Interventional

Funder types: Industry

Identifiers

NCT05547191

PN-00041

320237 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

Investigational device

Experimental group

Description:

ChloraSolv

Treatment:

Device: ChloraSolv