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

Phase 4

• Conditions: Surgical Wound Infection
• Interventions: Other: 2-Octyl Cyanoacrylate Glue

• Registration Number: NCT02779296
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-18
• Last Update Submitted: 2016-05-18
• Study First Posted: 2016-05-20
• Last Update Posted: 2016-05-20
• Study Start: 2016-06
• Primary Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2-Octyl Cyanoacrylate Glue	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.

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection	30 days post surgery

Secondary Outcome Measures

Name	Time	Method
Other Surgical Complications	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	8 months post surgery
Cost Analysis to determine the cost to treat a patient with and without a surgical site infection	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).