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NCT02718625 · ClinicalTrials.gov registry record · Phase 4

Study of SANTYL® vs Hydrogel (SoloSite®) for Pressure Ulcers

A Phase 4 study, sponsored by Smith & Nephew.

Terminated
Registry status
Phase 4
Development phase
3
Enrollment target

NCT02718625: Clinical Trial Phase 4 study, sponsored by Smith & Nephew.

NCT02718625 is a Phase 4 study that was terminated before completion, run by Smith & Nephew. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02718625, a Phase 4 study, was terminated before completion, sponsored by Smith & Nephew.

TERMINATED
Registry status
Phase 4
Development phase
3 participants
Enrollment target

Study Summary

This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of pressure ulcers for participants in a long-term care facility. After meeting study criteria, participants will be randomly assigned for application of SANTYL® or SoloSite® to their pressure ulcer for up to 6 weeks. A study previously conducted showed that in the long-term care setting, the removal of dead skin (debridement) with SANTYL® resulted in more participants achieving complete debridement, more rapidly than when SoloSite® is used. The goal of the present study is to confirm the results of the earlier study, demonstrating superior debridement outcomes for pressure ulcers of patients in long-term care as compared to ulcers managed with SoloSite®.

Primary Outcome

For purposes of the primary analysis, the status of complete debridement was to be assessed from photographs by two independent reviewers.

Interventions

  • BIOLOGICAL Santyl
  • BIOLOGICAL SoloSite®

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2016-08
Est. Completion 2017-03-09
Phase Phase 4
Smith & Nephew

72 total trials

Why NCT02718625 stopped before completion

NCT02718625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Santyl is the first listed.

NCT02718625 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02718625 about?

NCT02718625 is a clinical study titled "Study of SANTYL® vs Hydrogel (SoloSite®) for Pressure Ulcers". This study is designed to compare SANTYL® versus hydrogel (SoloSite®) in the treatment of pressure ulcers for participants in a long-term care facility. After meeting study criteria, participants will be randomly assigned for application of SANTYL® or SoloSite® to their pressure ulcer for up to 6 we...

What is the current status of trial NCT02718625?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2016-08. Estimated completion is 2017-03-09.

What interventions are being tested in trial NCT02718625?

The interventions under investigation include: Santyl (BIOLOGICAL), SoloSite® (BIOLOGICAL).

Who is sponsoring clinical trial NCT02718625?

This trial is sponsored by Smith & Nephew, which has 72 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02718625's enrollment target sits among peer trials

3 1995th of 2000 higher than 3 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 NCT02718625, the US trial registry maintained by the National Library of Medicine. NCT02718625 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.