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

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).

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Key information

Conditions

Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fakultni nemocnice u sv. Anny, Brno, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Epipad

Primary outcomes

Change in the wound dimensions (width x length)

Time frame: Week 3

Change in the wound dimensions from baseline

Sponsors and collaborators

Lead sponsor

Contipro Pharma a.s.

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Nov 16, 2022
Registry last updated: Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed