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

NCT00558246 | Completed Phase 4 Results

• 1 other identifier: 07CS003
• Study Type: interventional
• Target: 79
• Locations: 4 countries
• Sites: 5

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).

Conditions

Macromastia

Keywords

Breast Lift; Breast Reduction; Breast Reconstruction; Plastic Surgery; Skin Closure; Wound Healing; Dermabond

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  12-25 days

Secondary Outcomes (4)

• Time (Minutes) Required to Close the Final Skin Layer

  Intraoperative

• Cosmetic Outcome

  90 days post-procedure

• Cosmetic Outcome

  6 months

• Cosmetic Outcome

  12 months

Study Arms (2)

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)

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

Interventions

Dermabond Protape (Prineo) DEVICE

cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive

Also known as: Prineo

I

Suture DEVICE

Topical Suturing

Also known as: Investigator selected the intradermal suture per standard local practice.

II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)\];
• Sign the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (5)

UZ

Ghent, Belgium

Location

Dreifaltigkeits-Krankenhaus

Cologne, Germany

Location

Markus Krankenhaus

Frankfurt, Germany

Location

Akademikliniken

Stockholm, Sweden

Location

Mid Essex Hospital

Broomfield, Essex, United Kingdom

Location

MeSH Terms

Conditions

Gigantomastia

Interventions

Sutures

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Limitations and Caveats

Limitations of this study include the fact that the patient served as her own control. Additionally, as in many device studies, because of the obvious difference in the investigated and the control devices, blinding was limited.

Results Point of Contact

• Title: Phyllis Britnell
• Organization: Ethicon

pbritnel@its.jnj.com

1 908 218-3060

Study Officials

• Helen Colquhoun, MD

  Pleiad Devices

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 14, 2007
• Study Start: August 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: October 1, 2009
• Last Updated: July 19, 2012
• Results First Posted: July 19, 2012

Record last verified: 2012-06

Locations

SE (1); BE (1); GB (1); DE (2)