Safety and Efficacy of ActiGraft Treatment in Wound Care in Medical Centers

RedDress Ltd.500 enrolled

Overview

Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Cutaneous Wounds

Interventions

ActiGraftDEVICE

Whole blood clot (WBC) gel

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is ≥18 years of age * Subject has an exuding cutaneous wound * Subject agrees to the use of his health data, including photos of his wound in analysis and publications * Subject/LAR must be able to read and understand English and/or Spanish Exclusion Criteria: * Subject/LAR is unable to read and understand English or Spanish.

Locations (1)

Wound Care Experts

Las Vegas, Nevada, United States

RECRUITING

Outcomes

Primary Outcomes

Percentage area reduction (PAR) at 4 weeks

Change from baseline at 4 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).

Time frame: 4 weeks

Nature, frequency, and severity of adverse events in the intent to treat population

Nature, frequency, and severity (by CTCAE5) of adverse events

Time frame: 1 year

Secondary Outcomes

Percentage area reduction at 8 and 12 weeks

Change from baseline at 8 and 12 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT).

Time frame: 12 weeks

Central Contacts

Sharon Sirota

CONTACT

+972545800765 sharon@reddress.co.il

Data from ClinicalTrials.gov

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