- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00558246
Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Gent, Belgium
- UZ
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Cologne, Germany
- Dreifaltigkeits-Krankenhaus
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Frankfurt, Germany
- Markus Krankenhaus
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Stockholm, Sweden
- Akademikliniken
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Essex
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Broomfield, Essex, United Kingdom
- Mid Essex Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: I
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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cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
Other Names:
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Active Comparator: II
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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Topical Suturing
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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12-25 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time (Minutes) Required to Close the Final Skin Layer
Time Frame: Intraoperative
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Overall time required to close final skin layer on each breast.
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Intraoperative
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Cosmetic Outcome
Time Frame: 90 days post-procedure
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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. |
90 days post-procedure
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Cosmetic Outcome
Time Frame: 6 months
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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. |
6 months
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Cosmetic Outcome
Time Frame: 12 months
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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. |
12 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Helen Colquhoun, MD, Pleiad Devices
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 07CS003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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