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

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT02779296

Collaborator

(none)

Enrollment

Arms

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound Infection	Other: 2-Octyl Cyanoacrylate Glue	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Surgical Site Infection [30 days post surgery]

Secondary Outcome Measures

Other Surgical Complications [30 days post surgery]
Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)
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 [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 [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).