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Trial Investigating Cyanoacrylate Glue to Prevent Surgical Site Infection Following Breast Surgery

Primary Purpose

Surgical Wound Infection

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
2-Octyl Cyanoacrylate Glue
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Wound Infection focused on measuring Cyanoacrylates, Mammaplasty, Mastectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • patient has provided signed consent
  • undergoing surgery on the breast

Exclusion Criteria:

  • Infection within 30 days
  • Previous hypersensitivity to cyanoacrylates or formaldehyde

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    2-Octyl Cyanoacrylate Glue

    No Glue

    Arm Description

    At the surgical site, a thin layer of cyanoacrylate glue will be applied over the sutures at the time of closure.

    No cyanoacrylate glue will be applied.

    Outcomes

    Primary Outcome Measures

    Surgical Site Infection

    Secondary Outcome Measures

    Other Surgical Complications
    Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)
    Other Surgical Complications
    Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)
    Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0
    Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0
    Cost Analysis to determine the cost to treat a patient with and without a surgical site infection
    This analysis will be conducted from a Ministry of Health perspective and will factor the additional cost of the glue with the additional cost of treating a surgical site infection (such as antibiotics, additional healthcare visits, treatments and procedures).

    Full Information

    First Posted
    May 2, 2016
    Last Updated
    May 18, 2016
    Sponsor
    Ottawa Hospital Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02779296
    Brief Title
    Trial Investigating Cyanoacrylate Glue to Prevent Surgical Site Infection Following Breast Surgery
    Official Title
    Trial Investigating Cyanoacrylate Glue to Prevent Surgical Site Infection Following Breast Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    March 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Surgical Site Infections (SSI) represents a significant complication in plastic surgery. Infections can result in a prolonged recovery and impair long-term cosmetic appearance. One potential method to reduce infection is by applying a thin layer of dermal glue over the sutures at the site of incision immediately after the surgery. Conventional closures, such as sutures or staples, leave the site vulnerable until epithelialization occurs in 24 to 48 hours. In contrast, dermal glue provides an instant, waterproof barrier and it has been shown to have intrinsic bacteriostatic properties. The glue is supplied as a liquid enclosed in a vial and when applied, polymerizes rapidly in an exothermic reaction in the presence of moisture to form a solid adhesive. 2-Octylcyanoacrylate (2-OCA)-based glue is formulated to be more flexible than previous preparations. The application of dermal glue is rapid, simple and requires no specific follow-up as it naturally sloughs off overtime. The purpose of this study is to determine if 2-OCA-based glue can reduce the rate of surgical site infection following surgery. Patients undergoing breast surgery will be recruited and randomized to either a group receiving a layer of glue over sutures following surgery or no treatment. Patients will be followed up at 30 days and at 8 months for signs of infection, additional complications and the visual appearance of the scars. The cost of treating and infection will be calculated to determine if using dermal glue to prevent infection is economically feasible. This research has the potential to find a method to reduce surgical site infection, which can be applied to other surgeries.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Wound Infection
    Keywords
    Cyanoacrylates, Mammaplasty, Mastectomy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    2-Octyl Cyanoacrylate Glue
    Arm Type
    Experimental
    Arm Description
    At the surgical site, a thin layer of cyanoacrylate glue will be applied over the sutures at the time of closure.
    Arm Title
    No Glue
    Arm Type
    No Intervention
    Arm Description
    No cyanoacrylate glue will be applied.
    Intervention Type
    Other
    Intervention Name(s)
    2-Octyl Cyanoacrylate Glue
    Other Intervention Name(s)
    DERMABOND®, LIQUIBAND Exceed™, Tissue Adhesive, Dermal Glue
    Intervention Description
    topical
    Primary Outcome Measure Information:
    Title
    Surgical Site Infection
    Time Frame
    30 days post surgery
    Secondary Outcome Measure Information:
    Title
    Other Surgical Complications
    Description
    Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)
    Time Frame
    30 days post surgery
    Title
    Other Surgical Complications
    Description
    Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)
    Time Frame
    8 months post surgery
    Title
    Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0
    Time Frame
    30 days post surgery
    Title
    Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0
    Time Frame
    8 months post surgery
    Title
    Cost Analysis to determine the cost to treat a patient with and without a surgical site infection
    Description
    This analysis will be conducted from a Ministry of Health perspective and will factor the additional cost of the glue with the additional cost of treating a surgical site infection (such as antibiotics, additional healthcare visits, treatments and procedures).
    Time Frame
    8 months post surgery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patient has provided signed consent undergoing surgery on the breast Exclusion Criteria: Infection within 30 days Previous hypersensitivity to cyanoacrylates or formaldehyde
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gloria M Rockwell, MD, MSc
    Phone
    613-737-8899
    Ext
    71087

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    7594385
    Citation
    Quinn JV, Osmond MH, Yurack JA, Moir PJ. N-2-butylcyanoacrylate: risk of bacterial contamination with an appraisal of its antimicrobial effects. J Emerg Med. 1995 Jul-Aug;13(4):581-5. doi: 10.1016/0736-4679(95)80025-5.
    Results Reference
    background
    PubMed Identifier
    15799803
    Citation
    Hall LT, Bailes JE. Using Dermabond for wound closure in lumbar and cervical neurosurgical procedures. Neurosurgery. 2005 Jan;56(1 Suppl):147-50; discussion 147-50. doi: 10.1227/01.neu.0000144170.39436.52.
    Results Reference
    background

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    Trial Investigating Cyanoacrylate Glue to Prevent Surgical Site Infection Following Breast Surgery

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