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NCT04601532 · ClinicalTrials.gov registry record · Phase 4

Superficial Partial-Thickness Burn Study

A Phase 4 study, sponsored by J. Peter Rubin, MD.

Terminated
Registry status
Phase 4
Development phase
26
Enrollment target

NCT04601532: Clinical Trial Phase 4 study, sponsored by J. Peter Rubin, MD.

NCT04601532 is a Phase 4 study that was terminated before completion, run by J. Peter Rubin, MD. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04601532, a Phase 4 study, was terminated before completion, sponsored by J. Peter Rubin, MD.

TERMINATED
Registry status
Phase 4
Development phase
26 participants
Enrollment target

Study Summary

This study is an investigator initiated, single site, University of Pittsburgh, prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to the current gold standard treatment Silvadene (control group). Both groups will receive the same care other than the treating agent. Subjects will be recruited form the UPMC Mercy Burn Center adult patient pool who have sustained superficial partial-thickness burn wounds that comprise less than or equal to 10% of total body surface area (TBSA)

Primary Outcome

Number of days to healed burn wound (re-epithelialization as defined by greater than or equal to 90% epithelialized wound, determined by investigator exam and review of wound photographs, as needed)

Interventions

  • DEVICE Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser
  • DRUG Silver Sulfadiazine

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2021-06-11
Est. Completion 2022-12-08
Phase Phase 4
J. Peter Rubin, MD

4 total trials

Why NCT04601532 stopped before completion

NCT04601532 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser is the first listed.

NCT04601532 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04601532 about?

NCT04601532 is a clinical study titled "Superficial Partial-Thickness Burn Study". This study is an investigator initiated, single site, University of Pittsburgh, prospective, parallel group, randomized controlled trial comparing SynePure Wound Cleanser and Catasyn Advanced Technology Hydrogel (intervention group) to the current gold standard treatment Silvadene (control group). B...

What is the current status of trial NCT04601532?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2021-06-11. Estimated completion is 2022-12-08.

What interventions are being tested in trial NCT04601532?

The interventions under investigation include: Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser (DEVICE), Silver Sulfadiazine (DRUG).

Who is sponsoring clinical trial NCT04601532?

This trial is sponsored by J. Peter Rubin, MD, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04601532's enrollment target sits among peer trials

26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04601532, the US trial registry maintained by the National Library of Medicine. NCT04601532 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.