NCT02779296

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
12 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

May 2, 2016

Last Update Submit

May 18, 2016

Conditions

Surgical Wound Infection

Keywords

CyanoacrylatesMammaplastyMastectomy

Outcome Measures

Primary Outcomes (1)

  • Surgical Site Infection

    30 days post surgery

Secondary Outcomes (5)

  • Other Surgical Complications

    30 days post surgery

  • Other Surgical Complications

    8 months post surgery

  • 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

Study Arms (2)

2-Octyl Cyanoacrylate Glue

EXPERIMENTAL

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

No Glue

NO INTERVENTION

No cyanoacrylate glue will be applied.

Interventions

2-Octyl Cyanoacrylate GlueOTHER

topical

Also known as: DERMABOND®, LIQUIBAND Exceed™, Tissue Adhesive, Dermal Glue
2-Octyl Cyanoacrylate Glue

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 7594385BACKGROUND

  • 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.

    PMID: 15799803BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

octyl 2-cyanoacrylateTissue Adhesives

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesSurgical Fixation DevicesSurgical EquipmentEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Central Study Contacts

Gloria M Rockwell, MD, MSc

CONTACT

613-737-8899

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 20, 2016

Study Start

June 1, 2016

Primary Completion

March 1, 2017

Last Updated

May 20, 2016

Record last verified: 2016-05