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OpenTrials
Completed

NCT Number: NCT00558246

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

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).

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Key information

Conditions

Macromastia Gigantomastia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UZ, Ghent, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dermabond Protape (Prineo)

Device

cyanoacrylate and pressure sensitive adhesive mesh - topical skin adhesive

Other names: Prineo

Suture

Device

Topical Suturing

Other names: Investigator selected the intradermal suture per standard local practice.

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.

    Time frame: 12-25 days

    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.

Secondary outcomes

  1. Time (Minutes) Required to Close the Final Skin Layer

    Time frame: Intraoperative

    Overall time required to close final skin layer on each breast.

  2. Cosmetic Outcome

    Time frame: 90 days post-procedure

    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.

  3. Cosmetic Outcome

    Time frame: 6 months

    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.

  4. Cosmetic Outcome

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Ethicon, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Nov 14, 2007
Registry last updated
Jul 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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