Wound
Conditions
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).
Interventions
DEVICESodium 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.
Sponsors
Contipro Pharma a.s.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the wound dimensions (width x length) | Week 3 | Change in the wound dimensions from baseline |
Countries
Czechia
Outcome results
None listed