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

Contipro

Status

Completed

Conditions

Wound

Treatments

Device: Sodium Hyaluronate Lyophilizate

Study type

Interventional

Funder types

Other

Identifiers

NCT05618496

PT-EPI-1_09-20

Details and patient eligibility

About

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).

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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