Multi-centre, Open-label, First-in-man Study With Epipad Used in Adult Patients

NCT05618496 | Completed

• 1 other identifier: PT-EPI-1_09-20
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 4

Brief Summary

The main objective of the trial is to confirm safety of a new product - Epipad. The main impact of the device is to provide good environment for the healing of chronic wounds and wounds in the last healing phase (granulation and epithelisation).

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

• Change in the wound dimensions (width x length)

  Change in the wound dimensions from baseline

  Week 3

Study Arms (1)

Patients treated with Epipad

EXPERIMENTAL

Epipad

Device: Sodium Hyaluronate Lyophilizate

Interventions

Sodium Hyaluronate Lyophilizate DEVICE

Device is placed directly onto the treated wound. The wound should be cleaned with antiseptic solution prior to the device administration. The device is fixed on the wound by secondary dressing: e.g. plaster, compression.

Also known as: Epipad

Patients treated with Epipad

Eligibility Criteria

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

You may qualify if:

• Patient suffered from superficial wound of different etiology
• Wounds in terminal phase of healing
• Wounds without visible sign of infection
• Max. size of the wound: 10 x 20 cm (i.e. two pieces of the product)
• Duration of wound treatment of at least 6 weeks
• Subject willing and able to provide written informed consent
• Ability to communicate well with the investigator in local language, and to understand and comply with the requirements of the study

You may not qualify if:

• Sloughy or necrotic wound bed
• Severely contaminated or infected wound
• Age \< 18 years
• Pregnant or lactating woman
• Subject in terminal stage of living
• Subject with cancer disease
• Subject with known hypersensitivity or allergy to any component of the investigational device
• Subject participating in other interventional clinical trial
• Alcohol and/or drug abuse

Sponsors & Collaborators

• Contipro Pharma a.s.: lead

Study Sites (4)

Fakultni nemocnice u sv. Anny

Brno, Czechia

Location

Levitovo centrum nasledne pece

Hořice, Czechia

Location

Vojenska nemocnice Olomouc

Olomouc, Czechia

Location

Vsetinska nemocnice

Vsetín, Czechia

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 16, 2022
• Study Start: October 26, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (4)