CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 83 enrolled
Drug / intervention
Suture +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00557947
NCT00557947Phase 4Completed
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Multi-centre Study to Show Equivalence of Prineo (Dermabond Protape) to Intradermal Sutures for Skin Closure of Full-thickness Surgical Incisions

Ethicon, Inc.·interventional·Posted Nov 14, 2007·Updated Jul 19, 2012

In Brief

A Phase 4 clinical trial evaluating Suture and Dermabond Protape (Prineo) for Surgical Incisions. Completed, enrolled 83 participants across 5 sites in 4 countries.

Detailed Summary

This is a prospective, controlled, randomized, multi-center clinical study of up to 80 subjects with full thickness surgical incisions. Each incision included in the study will be segmented into two halves; each half will be randomized to receive final skin closure with either Prineo (DERMABOND PROTAPE) or intradermal sutures. Subjects will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgical Incisions
CountriesBelgium, Germany, Sweden, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 14, 2007
Enrollment StartAug 1, 2007
Primary CompletionApr 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.6 years ago

Interventions

Suturedevice

intradermal and topical suturing

Dermabond Protape (Prineo)device

cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive