Clinical trial NCT02779296: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Surgical Wound Infection
Keywords: Cyanoacrylates
Mammaplasty
Mastectomy
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Surgical Site Infection
timeFrame: 30 days post surgery
Secondary outcomes:
measure: Other Surgical Complications
timeFrame: 30 days post surgery
measure: Other Surgical Complications
timeFrame: 8 months post surgery
measure: Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0
timeFrame: 30 days post surgery
measure: Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0
timeFrame: 8 months post surgery
measure: Cost Analysis to determine the cost to treat a patient with and without a surgical site infection
timeFrame: 8 months post surgery
Other outcomes:
Locations:
Study officials:
References:
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.
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.