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

Macromastia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00558246
• Other study ID #: 07CS003
• Status: Completed
• Phase: Phase 4
• First received: November 9, 2007
• Last updated: June 13, 2012
• Start date: August 2007
• Est. completion date: October 2009

Study information

• Verified date: June 2012
• Source: Ethicon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionBelgium: Institutional Review BoardUnited Kingdom: Research Ethics CommitteeSweden: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: October 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macromastia

Intervention

Device:
• Dermabond Protape (Prineo)
cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive
• Suture
Topical Suturing

Locations

Country	Name	City	State
Belgium	UZ	Gent
Germany	Dreifaltigkeits-Krankenhaus	Cologne
Germany	Markus Krankenhaus	Frankfurt
Sweden	Akademikliniken	Stockholm
United Kingdom	Mid Essex Hospital	Broomfield	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon, Inc.

Countries where clinical trial is conducted

Belgium,  Germany,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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	Yes
Secondary	Time (Minutes) Required to Close the Final Skin Layer	Overall time required to close final skin layer on each breast.	Intraoperative	No
Secondary	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	No
Secondary	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	No
Secondary	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	No