PMCF Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries

NCT06183086 | Unknown

• 1 other identifier: BA-O-H-23029
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety and performance of Linovera® in the treatment of Category- I pressure ulcers/injuries.

Conditions

Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

• Safety of Linovera®

  Number of patients with at least one Adverse Device Effect (ADE) or Severe Adverse Device Effect (SADE).

  From the date of start of study until Category-1 pressure ulcer/injury heals or patient discharge, whichever came first, assessed up to 30 days

Secondary Outcomes (4)

• Healing of the Category-1 pressure ulcer/injury

  From the start of the study until the first 72 hours and when the Category-1 pressure ulcer/injury healed and/or at patient discharge

• Patient and intended user satisfaction

  From the start of the study until the first 72 hours and when the Category-1 pressure ulcer/injury healed and/or at patient discharge

• Ease of use of the device

  From the start of the study until Category-1 pressure ulcer/injury healed and/or at patient discharge, whichever came first, assessed up to 30 days

• Cumulative rates of each ADE/SADE

  From the start of the study until Category-1 pressure ulcer/injury healed or patient discharge, whichever came first, assessed up to 30 days

Study Arms (1)

Linovera

Apply Linovera under clinical routine practice

Device: Linovera®

Interventions

Linovera® DEVICE

Apply Linovera® at least twice a day (recommended every 12 h) on the pressure ulcer/injury until Category-1 pressure ulcer/injury is healed or until discharge.

Linovera

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

See eligibility criteria

You may qualify if:

• Adult patient (≥ 18 years)
• Patients with at least one Category-I PU/I (remark: follow-up will be done for one ulcer per patient).
• Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the EC prior to all evaluations.
• Patient naïve to Linovera® 2 weeks before visit 1 (only applicable to the area of the skin that will be assessed).
• Patients which can be potentially followed until their Category-1 pressure ulcer/injury is healed throughout the duration of the study, according to the clinicians opinion.

You may not qualify if:

• Age \<18 years
• Known allergies and/or hypersensitivity to any component of Linovera®.
• Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures.
• Any planned intervention that, in the investigator opinion, may affect skin condition of the patient (e.g. chemotherapy or radiotherapy).
• Simultaneous participation in an interventional clinical trial (drugs or medical devices studies).
• Any other additional topical treatments applied in the area of the skin that will be assessed.

Sponsors & Collaborators

• B. Braun Medical SA: lead

Study Sites (1)

Hospital Universitario Central de Asturias

Oviedo, Spain

RECRUITING

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Susana Valerdiz

  Hospital Universitario Central de Asturias

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aina Fernández

CONTACT

+34 663 895 945; aina.fernandez@bbraun.com

Joan LLuís Perez

CONTACT

+34 670 528 799; joan_lluis.perez@bbraun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: December 27, 2023
• Study Start: November 14, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

ES (1)