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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00558246
Other study ID # 07CS003
Secondary ID
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


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
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