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NCT01365273 · ClinicalTrials.gov registry record · Phase 4

Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts

A Phase 4 study, sponsored by Molnlycke Health Care AB.

Completed
Registry status
Phase 4
Development phase
43
Enrollment target

NCT01365273: Completed Phase 4 study, sponsored by Molnlycke Health Care AB.

NCT01365273 is a Phase 4 study that has completed, run by Molnlycke Health Care AB. The registered enrollment target is 43 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01365273, a Phase 4 study, has completed, sponsored by Molnlycke Health Care AB.

COMPLETED
Registry status
Phase 4
Development phase
43 participants
Enrollment target

Study Summary

This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5 centres in the US with deep-partial of full thickness burns in need of skin grafts will be enrolled.The subjects will be equally randomised to either treatment with Mepitel One or bridal veil together with staples. The primary objective is to compare pain at the time of dressing change for the use of Mepitel One versus bridal veil together with staples on deep partial or full thickness burns requiring skin grafts.

Primary Outcome

Pain was measured with Visual Analogue Scale (VAS)(100 mm) measuring from 0 = "no pain" at one end to 100 = "most intense pain imagaginable" at the other end.

Interventions

  • DEVICE Mepitel One

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2011-02
Est. Completion 2011-12
Phase Phase 4
Molnlycke Health Care AB

20 total trials

What the finished NCT01365273 record still lists

NCT01365273 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Mepitel One is the first listed.

NCT01365273 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01365273 about?

NCT01365273 is a clinical study titled "Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts". This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5 centres in the US with deep-partial of full thickness burns in need of skin grafts will be enrolled.The subjects will be equally randomised to either treatment with Mepitel One or bridal veil together with stap...

What is the current status of trial NCT01365273?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 43 participants. The study started on 2011-02. Estimated completion is 2011-12.

What interventions are being tested in trial NCT01365273?

The interventions under investigation include: Mepitel One (DEVICE).

Who is sponsoring clinical trial NCT01365273?

This trial is sponsored by Molnlycke Health Care AB, which has 20 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01365273's enrollment target sits among peer trials

43 1371st of 2000 higher than 621 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 NCT01365273, the US trial registry maintained by the National Library of Medicine. NCT01365273 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.