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

NCT ID: NCT02779296

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30

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.

Conditions

Surgical Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

2-Octyl Cyanoacrylate Glue

Intervention Type: OTHER

topical

No Glue

No cyanoacrylate glue will be applied.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

2-Octyl Cyanoacrylate Glue

topical

Intervention Type: OTHER

Other Intervention Names

DERMABOND®; LIQUIBAND Exceed™; Tissue Adhesive; Dermal Glue

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Gloria M Rockwell, MD, MSc

Role: CONTACT

613-737-8899 ext. 71087

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.

Reference Type: BACKGROUND

PMID: 7594385 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15799803 (View on PubMed)

Other Identifiers

OHSN-REB #20160009-01H

Identifier Type: -

Identifier Source: org_study_id