Trial Investigating Cyanoacrylate Glue to Prevent Surgical Site Infection Following Breast Surgery
Primary Purpose
Surgical Wound Infection
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
2-Octyl Cyanoacrylate Glue
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection focused on measuring Cyanoacrylates, Mammaplasty, Mastectomy
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
2-Octyl Cyanoacrylate Glue
No Glue
Arm Description
At the surgical site, a thin layer of cyanoacrylate glue will be applied over the sutures at the time of closure.
No cyanoacrylate glue will be applied.
Outcomes
Primary Outcome Measures
Surgical Site Infection
Secondary Outcome Measures
Other Surgical Complications
Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)
Other Surgical Complications
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
Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0
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).
Full Information
NCT ID
NCT02779296
First Posted
May 2, 2016
Last Updated
May 18, 2016
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02779296
Brief Title
Trial Investigating Cyanoacrylate Glue to Prevent Surgical Site Infection Following Breast Surgery
Official Title
Trial Investigating Cyanoacrylate Glue to Prevent Surgical Site Infection Following Breast Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Cyanoacrylates, Mammaplasty, Mastectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2-Octyl Cyanoacrylate Glue
Arm Type
Experimental
Arm Description
At the surgical site, a thin layer of cyanoacrylate glue will be applied over the sutures at the time of closure.
Arm Title
No Glue
Arm Type
No Intervention
Arm Description
No cyanoacrylate glue will be applied.
Intervention Type
Other
Intervention Name(s)
2-Octyl Cyanoacrylate Glue
Other Intervention Name(s)
DERMABOND®, LIQUIBAND Exceed™, Tissue Adhesive, Dermal Glue
Intervention Description
topical
Primary Outcome Measure Information:
Title
Surgical Site Infection
Time Frame
30 days post surgery
Secondary Outcome Measure Information:
Title
Other Surgical Complications
Description
Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)
Time Frame
30 days post surgery
Title
Other Surgical Complications
Description
Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)
Time Frame
8 months post surgery
Title
Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0
Time Frame
30 days post surgery
Title
Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0
Time Frame
8 months post surgery
Title
Cost Analysis to determine the cost to treat a patient with and without a surgical site infection
Description
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).
Time Frame
8 months post surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gloria M Rockwell, MD, MSc
Phone
613-737-8899
Ext
71087
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
7594385
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. doi: 10.1016/0736-4679(95)80025-5.
Results Reference
background
PubMed Identifier
15799803
Citation
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.
Results Reference
background
Learn more about this trial
Trial Investigating Cyanoacrylate Glue to Prevent Surgical Site Infection Following Breast Surgery
We'll reach out to this number within 24 hrs