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

Not Applicable

Completed

• Conditions: Wound
• Interventions: Device: Sodium Hyaluronate Lyophilizate

• Registration Number: NCT05618496
• Lead Sponsor: Contipro Pharma a.s.

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-26
• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-11-09
• Study First Posted: 2022-11-16
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients treated with Epipad	Sodium Hyaluronate Lyophilizate	Epipad

Primary Outcome Measures

Name	Time	Method
Change in the wound dimensions (width x length)	Week 3	Change in the wound dimensions from baseline

Trial Locations

Locations (4)

Vojenska nemocnice Olomouc; 🇨🇿 Olomouc, Czechia

Vsetinska nemocnice; 🇨🇿 Vsetín, Czechia

Fakultni nemocnice u sv. Anny; 🇨🇿 Brno, Czechia

Levitovo centrum nasledne pece; 🇨🇿 Hořice, Czechia