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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00557947
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 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).


Condition Intervention Phase
Surgical Incisions
 Device: Suture
Device: Dermabond Protape (Prineo)
 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

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 post-operation ] [ Designated as safety issue: No ]
    Equivalence is 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) does not exceed 12%.


Secondary Outcome Measures:
  • Time Required to Close the Final Skin Layer [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    Time to close final skin layer for each incision segment.

  • 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 incisions with good outcomes were then compared to those with poor outcomes.

    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 incisions with good outcomes were then compared to those with poor outcomes.

    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 month ] [ 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 incisions with good outcomes were then compared to those with poor outcomes.

    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: 83
Study Start Date: August 2007
Study Completion Date: April 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Dermabond Protape-Incision segments are randomized & patient is own control
 Device: Dermabond Protape (Prineo)
cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
Other Name: Prineo
Active Comparator: II
Intradermal Suture - Incision segments are randomized & patient is own control. Investigator selected suture on the basis of standard local practice.
 Device: Suture
intradermal and 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:   Yes
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;
  • Be scheduled for at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty or body lift 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 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 or have participated in any clinical trial within 30 days of enrolment in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557947

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: NCT00557947     History of Changes
Other Study ID Numbers: 06CS005
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.:
Abdominoplasty
Body Lift
Plastic Surgery
 Skin Closure
Wound Healing
Dermabond

ClinicalTrials.gov processed this record on May 19, 2013