Clinical trial NCT00558246: Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Macromastia
Keywords: Breast Lift
Breast Reduction
Breast Reconstruction
Plastic Surgery
Skin Closure
Wound Healing
Dermabond
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 12-25 days
Secondary outcomes:
measure: Time (Minutes) Required to Close the Final Skin Layer
timeFrame: Intraoperative
measure: Cosmetic Outcome
timeFrame: 90 days post-procedure
measure: Cosmetic Outcome
timeFrame: 6 months
measure: Cosmetic Outcome
timeFrame: 12 months
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: UZ
city: Cologne
country: Germany
facility: Dreifaltigkeits-Krankenhaus
city: Frankfurt
country: Germany
facility: Markus Krankenhaus
city: Stockholm
country: Sweden
facility: Akademikliniken
city: Broomfield
country: United Kingdom
facility: Mid Essex Hospital
state: Essex
Study officials:
affiliation: Pleiad Devices
name: Helen Colquhoun, MD
role: STUDY_DIRECTOR
References: