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Surgical Wound InfectionPhase 4NCT02779296

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

A Phase 4 study testing 2-Octyl Cyanoacrylate Glue in people with Surgical Wound Infection, run by Ottawa Hospital Research Institute.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Surgical Wound Infection
What is being tested?
2-Octyl Cyanoacrylate Glue
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Jun 2016to Mar 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Gloria M Rockwell, MD, MSc contact

613-737-8899 ext. 71087

About this study

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.

Being tested
2-Octyl Cyanoacrylate Glue
Keywords
Cyanoacrylates, Mammaplasty, Mastectomy
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2-Octyl Cyanoacrylate GlueOther

    Also called DERMABOND®, LIQUIBAND Exceed™, Tissue Adhesive, Dermal Glue

    topical

Study groups in NCT02779296
Study groupRoleWhat they receive
2-Octyl Cyanoacrylate GlueExperimentalAt the surgical site, a thin layer of cyanoacrylate glue will be applied over the sutures at the time of closure.
Receives: Other: 2-Octyl Cyanoacrylate Glue
No GlueNo interventionNo cyanoacrylate glue will be applied.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgical Site Infection

    Measured: 30 days post surgery

Secondary outcomes (5)

  1. Other Surgical Complications

    Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)

    Measured: 30 days post surgery

  2. Other Surgical Complications

    Hematoma, seroma, wound dehiscence, scar hyperpigmentation, necrosis (nipple areolar complex, wound edges, fat tissue)

    Measured: 8 months post surgery

  3. Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0

    Measured: 30 days post surgery

  4. Cosmetic Appearance assessed by the Patient and Observer Scar Assessment Scale (POSAS) v2.0

    Measured: 8 months post surgery

  5. 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).

    Measured: 8 months post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionMar 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02779296
Sponsor's protocol ID
OHSN-REB #20160009-01H
Status last verified
May 2016
First submitted
2 May 2016
Last updated
20 May 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 7594385

  • 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.

    PubMed 15799803

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 2-Octyl Cyanoacrylate Glue in people with Surgical Wound Infection, run by Ottawa Hospital Research Institute.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gloria M Rockwell, MD, MSc (613-737-8899 ext. 71087), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Site Infection (time frame: 30 days post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02779296, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.

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