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Sponsored by: |
Closure Medical Corporation |
Information provided by: | Closure Medical Corporation |
ClinicalTrials.gov Identifier: | NCT00558246 |
This is a prospective, controlled, randomized, multi-center clinical study of up to 80 patients with full thickness surgical incisions associated with bi-lateral breast procedures. Breast procedures where symmetrical incisions of at least 15cm in length are planned for both breast (bilateral procedure) will be randomised to receive final skin closure of one breast with Prineo (DERMABOND PROTAPE) and the other with intradermal sutures (control). Patients will be evaluated post-operatively at 24 hours (± 6 hours), 7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days).
Condition | Intervention | Phase |
Surgical Incision Segments |
Device: Dermabond Protape (Prineo) Device: Suture |
Phase IV |
ChemIDplus related topics: | Poliglecaprone 25 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Multi-Centre Study to Show Equivalence of Prineo (DERMABOND PROTAPE) to Intradermal Sutures for Skin Closure of Full-Thickness Surgical Incisions Associated With Breast Procedures |
Estimated Enrollment: | 80 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
I: Experimental
On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
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Device: Dermabond Protape (Prineo)
cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
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II: Active Comparator
On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
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Device: Suture
Topical Suturing
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |||||
UZ | |||||
Gent, Belgium | |||||
Germany | |||||
Dreifaltigkeits-Krankenhaus | |||||
Cologne, Germany | |||||
Markus Krankenhaus | |||||
Frankfurt, Germany | |||||
Sweden | |||||
Akademikliniken | |||||
Stockholm, Sweden | |||||
United Kingdom, Essex | |||||
Mid Essex Hospital | |||||
Broomfield, Essex, United Kingdom |
Closure Medical Corporation |
Study Director: | Helen Colquhoun, MD | Pleiad Devices |
Responsible Party: | Closure Medical Corporation ( Kimberly Hunsicker, Associate Director Clinical Programs ) |
Study ID Numbers: | 07CS003 |
First Received: | November 9, 2007 |
Last Updated: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00558246 |
Health Authority: | Germany: Ethics Commission; Belgium: Institutional Review Board; United Kingdom: Research Ethics Committee; Sweden: Institutional Review Board |
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