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NCT03070925 · ClinicalTrials.gov registry record

Prospective PuraPly™ AM Case Series Study

A clinical trial of Pressure Ulcers and Venous Ulcers, sponsored by Organogenesis.

Completed
Registry status
43
Enrollment target
1
Study location

NCT03070925: Completed study of Pressure Ulcers and Venous Ulcers, sponsored by Organogenesis.

NCT03070925 is a study of Pressure Ulcers and Venous Ulcers that has completed, run by Organogenesis. The registered enrollment target is 43 participants, below the 225-participant average among 5 other Pressure Ulcers trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03070925, a study of Pressure Ulcers and Venous Ulcers, has completed, sponsored by Organogenesis.

COMPLETED
Registry status
43 participants
Enrollment target
1
Study location

Study Summary

The PuraPly AM case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (PHMB) and is intended for the management of wounds; no experimental intervention is involved.

Primary Outcome

As measured from change in status from baseline

Interventions

  • DEVICE PuraPly™ Antimicrobial Wound Matrix

Study Locations (1)

New York

  • Northwell Health, Inc - Lake Success

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2016-11
Est. Completion 2017-05
Organogenesis

20 total trials

What the finished NCT03070925 record still lists

NCT03070925 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 225-participant average among 5 other Pressure Ulcers trials with a reported enrollment target (81% lower).

The record links to 5 conditions, with Pressure Ulcers appearing as the primary indexed condition, and to 1 intervention - of which PuraPly™ Antimicrobial Wound Matrix is the first listed.

NCT03070925 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT03070925 about?

NCT03070925 is a clinical study titled "Prospective PuraPly™ AM Case Series Study". The PuraPly AM case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (PHMB) and is intended for the management of wounds; no experimental intervention is involved.

What is the current status of trial NCT03070925?

This trial is currently completed. The enrollment target is 43 participants. The study started on 2016-11. Estimated completion is 2017-05.

What conditions does trial NCT03070925 study?

This clinical trial studies the following conditions: Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Surgical Wounds, Trauma Wounds.

What interventions are being tested in trial NCT03070925?

The interventions under investigation include: PuraPly™ Antimicrobial Wound Matrix (DEVICE).

Who is sponsoring clinical trial NCT03070925?

This trial is sponsored by Organogenesis, which has 20 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03070925 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT03070925, the US trial registry maintained by the National Library of Medicine. NCT03070925 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.