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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Macromastia

Intervention / Treatment
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* Device: Dermabond Protape (Prineo)
* Device: Suture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>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)<br>* cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive<br>* Other names: Prineo;|
| Active Comparator: II<br>On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control. | Device: Suture<br>* Topical Suturing<br>* Other names: Investigator selected the intradermal suture per standard local practice.;|

What is the study measuring?
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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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time (Minutes) Required to Close the Final Skin Layer | Overall time required to close final skin layer on each breast. | Intraoperative | 
| Cosmetic Outcome | 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 | 
| Cosmetic Outcome | 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 | 
| Cosmetic Outcome | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Lift, Breast Reduction, Breast Reconstruction, Plastic Surgery, Skin Closure, Wound Healing, Dermabond