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NCT05618496 Clinical Trial

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

Wound Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05618496
Other study ID # PT-EPI-1_09-20
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 26, 2022
Est. completion date October 31, 2023

Study information
Verified date February 2024
Source Contipro Pharma a.s.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Sodium Hyaluronate Lyophilizate
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.

Locations
Country Name City State
Czechia Fakultni nemocnice u sv. Anny Brno
Czechia Levitovo centrum nasledne pece Horice
Czechia Vojenska nemocnice Olomouc Olomouc
Czechia Vsetinska nemocnice Vsetín

Sponsors (1)
Lead Sponsor Collaborator
Contipro Pharma a.s.

Country where clinical trial is conducted

Czechia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in the wound dimensions (width x length) Change in the wound dimensions from baseline Week 3
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