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

O

Ottawa Hospital Research Institute

Status and phase

Unknown
Phase 4

Conditions

Surgical Wound Infection

Treatments

Other: 2-Octyl Cyanoacrylate Glue

Study type

Interventional

Funder types

Other

Identifiers

NCT02779296
OHSN-REB #20160009-01H

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 2 patient groups

2-Octyl Cyanoacrylate Glue
Experimental group
Description:
At the surgical site, a thin layer of cyanoacrylate glue will be applied over the sutures at the time of closure.
Treatment:
Other: 2-Octyl Cyanoacrylate Glue
No Glue
No Intervention group
Description:
No cyanoacrylate glue will be applied.

Trial contacts and locations

0

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Central trial contact

Gloria M Rockwell, MD, MSc

Data sourced from clinicaltrials.gov

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