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Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00558246
First received: November 9, 2007
Last updated: June 13, 2012
Last verified: June 2012
History of Changes
  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
Macromastia
 Device: Dermabond Protape (Prineo)
Device: Suture
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Ethicon, Inc.:

Primary Outcome Measures:
  • Continuous Apposition of the Skin Edges Without Wound Dehiscence or Re-closure as Measured by the Upper Limit of 95% Confidence Interval in Proportion of Successes for Each Groups. [ Time Frame: 12-25 days ] [ Designated as safety issue: Yes ]
    Equivalence was demonstrated if the upper limit of the 95% confidence interval (when subtracting the percentage of DERMABOND PROTAPE successful subjects from the percentage of INTRADERMAL SUTURE successful subjects) did not exceed 12 percent.


Secondary Outcome Measures:
  • Time (Minutes) Required to Close the Final Skin Layer [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Overall time required to close final skin layer on each breast.

  • Cosmetic Outcome [ Time Frame: 90 days post-procedure ] [ Designated as safety issue: No ]

    Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.

    Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.


  • Cosmetic Outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.

    Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.


  • Cosmetic Outcome [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Modified Hollander Cosmesis Scale overall outcome score in which a score of 0 corresponds to a good outcome versus a 1-6 to a poor outcome. The proportions of breasts with good outcomes were then compared to those with poor outcomes in each group.

    Reference: Hollander JE, Singer AJ, Valentine S, Thode HC Jr, Henry MC. Wound registry:development and validation. Ann Emerg Med. 1995;25:675-85.



Enrollment: 79
Study Start Date: August 2007
Study Completion Date: October 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
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
Other Name: Prineo
Active Comparator: II
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
Other Name: Investigator selected the intradermal suture per standard local practice.

  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)], six (± 1 month) and twelve months (± 1 month)];
  • 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
Mid Essex Hospital
Broomfield, Essex, United Kingdom
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: Helen Colquhoun, MD Pleiad Devices
  More Information

No publications provided

Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT00558246     History of Changes
Other Study ID Numbers: 07CS003
Study First Received: November 9, 2007
Results First Received: June 13, 2012
Last Updated: June 13, 2012
Health Authority: Germany: Ethics Commission
Belgium: Institutional Review Board
United Kingdom: Research Ethics Committee
Sweden: Institutional Review Board

Keywords provided by Ethicon, Inc.:
Breast Lift
Breast Reduction
Breast Reconstruction
Plastic Surgery
 Skin Closure
Wound Healing
Dermabond

ClinicalTrials.gov processed this record on May 16, 2013