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Enrolling By Invitation
NCT05618496
Multi-centre, Open-label, First-in-man Study With Epipad Used in Adult Patients
Conditions: Wound
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 60
Sponsor: Contipro Pharma a.s.
Location: Czechia
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).
Eligibility Criteria
Inclusion Criteria:Patient suffered from superficial wound of different etiologyWounds in terminal phase of healingWounds without visible sign of infectionMax. size of the wound: 10 x 20 cm (i.e. two pieces of the product)Duration of wound treatment of at least 6 weeksSubject willing and able to provide written informed consentAbility to communicate well with the investigator in local language, and to understand and comply with the requirements of the studyExclusion Criteria:Sloughy or necrotic wound bedSeverely contaminated or infected woundAge < 18 yearsPregnant or lactating womanSubject in terminal stage of livingSubject with cancer diseaseSubject with known hypersensitivity or allergy to any component of the investigational deviceSubject participating in other interventional clinical trialAlcohol and/or drug abuse
Source: ClinicalTrials.gov (NCT05618496). StuddyBuddy aggregates publicly available trial information.