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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Wound

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