Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures - Full Text View

Purpose

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

U.S. FDA Resources

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

Further study details as provided by Closure Medical Corporation:

Primary Outcome Measures:

Continuous apposition of the skin edges without wound dehiscence or re-closure. [ Time Frame: 12-25 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Time required to close the final skin layer [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
The evaluation of incision healing and cosmetic outcome using the modified Hollander Cosmesis Scale (mHCS). [ Time Frame: 90 days post-procedure ] [ Designated as safety issue: No ]

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.	Device: Dermabond Protape (Prineo) cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
II: Active Comparator On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.	Device: Suture Topical Suturing

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Be at least 18 years of age;
Be in good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history and review of recent concomitant medications;
Require identical skin closure of full-thickness intersecting surgical incisions with a combined length of at least 15cm on each breast as part of elective breast procedures, requiring the placement of sutures in the superficial fascia and subcutaneous tissue to relieve skin tension prior to final skin closure;
Be willing to follow instructions for incision care as instructed by the investigator, and refrain from swimming or soaking in a tub until suture removal occurs (during the first 12-25 days) of the study;
Agree to return for all follow-up evaluations specified in this protocol [7 days (± 1 day), 12 - 25 days, and 90 days (± 10 days)];
Agree not to schedule any additional elective surgical procedures that involve an incision that is randomized for inclusion in this study, until their participation in this study is complete; and
Sign the informed consent.

Exclusion Criteria:

Have peripheral vascular disease;
Have insulin dependent diabetes mellitus;
Be known to have a blood clotting disorder;
Be receiving antibiotic therapy for pre-existing condition or infection;
Be known to be HIV-positive or otherwise immunocompromised;
Have known personal or family history of keloid formation or hypertrophy;
Be currently taking systemic steroids;
Have known or suspected allergy or sensitivity to cyanoacrylate, formaldehyde, tapes or adhesives
Have incision type or location known to have an incidence of cyanosis or other healing abnormalities; and
Be participating in any current clinical trial of an investigational product or have participated in any clinical trial of an investigational product within 30 days of enrolment in this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558246

Locations


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

Sponsors and Collaborators

Closure Medical Corporation

Investigators


Study Director:	Helen Colquhoun, MD	Pleiad Devices

More Information

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

Keywords provided by Closure Medical Corporation:

Breast Lift

Breast Reduction

Breast Reconstruction

Plastic Surgery

Skin Closure

Wound Healing

Dermabond

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Closure Medical Corporation
Information provided by:	Closure Medical Corporation
ClinicalTrials.gov Identifier:	NCT00558246