Phase 4 N=79 Randomized Treatment

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

Macromastia

Bottom Line

View on ClinicalTrials.gov: NCT00558246 ↗

Enrolled (actual)

Serious AEs

0.8%

Results posted

Jul 2012

Primary outcome: Primary: 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. — 76; 76 Participants — p=1.0000

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dermabond Protape (Prineo) (Device); Suture (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ethicon, Inc.
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	76; 76	1.0000
SECONDARY Time (Minutes) Required to Close the Final Skin Layer	2.56; 16.22	<0.0001 sig
SECONDARY Cosmetic Outcome	40; 43	0.5078
SECONDARY Cosmetic Outcome	40; 43	0.5078
SECONDARY Cosmetic Outcome	40; 43	0.5078

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00558246). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.