Multi-centre, Open-label, First-in-man Study With Epipad... | NCT05618496

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

NCT05618496

Sponsor

Contipro Pharma a.s.

Status

Completed

Last Update Posted

Feb 8, 2024Actual

Enrollment

52Actual

Phase

Not Applicable

Conditions

Wound

Interventions

Sodium Hyaluronate Lyophilizate

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 26, 2022Actual

Primary Completion Date

Oct 31, 2023Actual

Completion Date

Oct 31, 2023Actual

First Submitted Date

Nov 9, 2022

First Submission Date that Met QC Criteria

Nov 9, 2022

First Posted Date

Nov 16, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2024

Last Update Posted Date

Feb 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients treated with Epipad	Experimental	Epipad	Device: Sodium Hyaluronate Lyophilizate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the wound dimensions (width x length)	Change in the wound dimensions from baseline	Week 3

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fakultni nemocnice u sv. Anny		Brno			Czechia
Levitovo centrum nasledne pece

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided