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

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 Overview

• Status: Unknown
• Conditions: Surgical Wound Infection
• Intervention / Treatment: Other: 2-Octyl Cyanoacrylate Glue

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Gloria M Rockwell, MD, MSc; Phone Number: 71087 613-737-8899

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 2-Octyl Cyanoacrylate Glue; topical; Other Names: DERMABOND®; LIQUIBAND Exceed™; Tissue Adhesive; Dermal Glue
No Intervention: No Glue; No cyanoacrylate glue will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Surgical Site Infection	30 days post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other Surgical Complications	Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)	30 days post surgery
Other Surgical Complications	Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)	8 months post surgery
Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0		30 days post surgery
Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0		8 months post surgery
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).	8 months post surgery

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Estimate): May 20, 2016
• Last Update Submitted That Met QC Criteria: May 18, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Mastectomy; Mammaplasty; Cyanoacrylates
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Disease Attributes; Infections; Communicable Diseases; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: OHSN-REB #20160009-01H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided