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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2017

Interventions

  • Other: 2-Octyl Cyanoacrylate Glue
    • topical

Arms, Groups and Cohorts

  • Experimental: 2-Octyl Cyanoacrylate Glue
    • At the surgical site, a thin layer of cyanoacrylate glue will be applied over the sutures at the time of closure.
  • No Intervention: No Glue
    • No cyanoacrylate glue will be applied.

Clinical Trial Outcome Measures

Primary Measures

  • Surgical Site Infection
    • Time Frame: 30 days post surgery

Secondary Measures

  • Other Surgical Complications
    • Time Frame: 30 days post surgery
    • Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)
  • Other Surgical Complications
    • Time Frame: 8 months post surgery
    • 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
    • Time Frame: 30 days post surgery
  • Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0
    • Time Frame: 8 months post surgery
  • Cost Analysis to determine the cost to treat a patient with and without a surgical site infection
    • Time Frame: 8 months post surgery
    • 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).

Participating in This Clinical Trial

Inclusion Criteria

  • patient has provided signed consent – undergoing surgery on the breast Exclusion Criteria:

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ottawa Hospital Research Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Gloria M Rockwell, MD, MSc, 613-737-8899

References

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.

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.

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