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

Surgical Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02779296
• Other study ID #: OHSN-REB #20160009-01H
• Status: Not yet recruiting
• Phase: Phase 4
• First received: May 2, 2016
• Last updated: May 18, 2016
• Start date: June 2016

Study information

• Verified date: May 2016
• Source: Ottawa Hospital Research Institute
• Contact: Gloria M Rockwell, MD, MSc
• Phone: 613-737-8899
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Other:
• 2-Octyl Cyanoacrylate Glue
topical

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection		30 days post surgery	Yes
Secondary	Other Surgical Complications	Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)	30 days post surgery	Yes
Secondary	Other Surgical Complications	Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)	8 months post surgery	Yes
Secondary	Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0		30 days post surgery	No
Secondary	Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0		8 months post surgery	No
Secondary	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	No