MedTrace Logo

Prineo (Dermabond Protape) Versus Sutures for Full-thickness Surgical Incisions

NCT00557947 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2012-07-19

Study results available
· View outcomes & findings →

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).

Conditions

  • Surgical Incisions

Interventions

DEVICE

Suture

intradermal and topical suturing

DEVICE

Dermabond Protape (Prineo)

cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • Helen Colquhoun, MD · Pleiad Devices

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2008-04-30
Completion
2009-04-30

Countries

  • Belgium
  • Germany
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00557947 on ClinicalTrials.gov