Smoking Cessation in Nonunion, Malunion, Osseous Infection
| Status: | Withdrawn |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 3/23/2019 |
| Start Date: | October 2010 |
| End Date: | October 2012 |
Outcome of a Prospective Protocol for Smoking Cessation in Nonunion, Malunion, Osseous Infection, and Infected Nonunion Patients
The Study Investigators have seen high rates of tobacco cessation success combining Chantix
with the risk of no surgery, should tobacco use continue. Once patients achieve tobacco
cessation and undergo surgery, the investigators have seen high rates of union and/or
infection resolution. The investigators are looking to document and publish these
observations. To date, no studies have been published that have examined the effects of this
type of protocol on short and long-term tobacco cessation.
The investigators want to examine and report the outcome of Hershey Medical Center's
Orthopaedic Trauma Division's protocol for two endpoints: 1) pre-op tobacco cessation and 2)
duration of tobacco cessation. This protocol involves counseling, Chantix, and a 'no-surgery'
risk. Patients will be followed postoperatively for success and duration of tobacco
cessation, as well as for fracture union and/or infection eradication.
with the risk of no surgery, should tobacco use continue. Once patients achieve tobacco
cessation and undergo surgery, the investigators have seen high rates of union and/or
infection resolution. The investigators are looking to document and publish these
observations. To date, no studies have been published that have examined the effects of this
type of protocol on short and long-term tobacco cessation.
The investigators want to examine and report the outcome of Hershey Medical Center's
Orthopaedic Trauma Division's protocol for two endpoints: 1) pre-op tobacco cessation and 2)
duration of tobacco cessation. This protocol involves counseling, Chantix, and a 'no-surgery'
risk. Patients will be followed postoperatively for success and duration of tobacco
cessation, as well as for fracture union and/or infection eradication.
The Study Investigators have a Trauma subspecialty within Orthopaedic Surgery. We take care
of numerous patients with ununited or malunited fractures i.e., nonunion/malunion patients,
as well as patients with chronic bone infections, and patients with infected nonunions. The
literature is replete with articles documenting the negative effects of nicotine on fracture
healing and chronic bone infection resolution.(5) Many of our chronic infection and
nonunion/malunion patients use nicotine in some form. Most of these patients need additional
elective surgery to attain fracture union and/or infection resolution. Thus, we are faced
with the dilemma of adding an additional procedure to a patient with proven risk factors for
nonunion and continued infection. Much time is spent in clinic counseling patients about
smoking cessation, requisite for a successful surgical outcome. Since nicotine is extremely
addictive, our efforts at helping our trauma patients relinquish tobacco are not always
successful. Many of our patients need pharmacologic help with the goal of cessation, and we
have been providing Chantix prescriptions to them. In addition to providing Chantix, we
currently present to our patients, as standard of care, a requirement that smoking cessation
is necessary prior to performing additional surgical procedures.
Chantix (generic name, varenicline)is a relatively new drug designed for helping with tobacco
cessation. It has shown great promise for success since it both decreases cravings for
nicotine (the highly addictive active ingredient in tobacco) and diminishes withdrawal
symptoms of nicotine. This novel, dual approach works by binding to nicotinic receptors in
the brain as a partial agonist, decreasing the pleasurable effects of cigarettes and other
tobacco products. Once bound to these receptors, Chantix blocks actual nicotine. While
blocking nicotine receptors, it also acts like a weak substitute for nicotine, decreasing
symptoms of withdrawal. (2)
Our study will include 60 tobacco-using patients of all ages above 18 with osseous nonunion,
malunion, established bone infection, or combined diagnoses.
of numerous patients with ununited or malunited fractures i.e., nonunion/malunion patients,
as well as patients with chronic bone infections, and patients with infected nonunions. The
literature is replete with articles documenting the negative effects of nicotine on fracture
healing and chronic bone infection resolution.(5) Many of our chronic infection and
nonunion/malunion patients use nicotine in some form. Most of these patients need additional
elective surgery to attain fracture union and/or infection resolution. Thus, we are faced
with the dilemma of adding an additional procedure to a patient with proven risk factors for
nonunion and continued infection. Much time is spent in clinic counseling patients about
smoking cessation, requisite for a successful surgical outcome. Since nicotine is extremely
addictive, our efforts at helping our trauma patients relinquish tobacco are not always
successful. Many of our patients need pharmacologic help with the goal of cessation, and we
have been providing Chantix prescriptions to them. In addition to providing Chantix, we
currently present to our patients, as standard of care, a requirement that smoking cessation
is necessary prior to performing additional surgical procedures.
Chantix (generic name, varenicline)is a relatively new drug designed for helping with tobacco
cessation. It has shown great promise for success since it both decreases cravings for
nicotine (the highly addictive active ingredient in tobacco) and diminishes withdrawal
symptoms of nicotine. This novel, dual approach works by binding to nicotinic receptors in
the brain as a partial agonist, decreasing the pleasurable effects of cigarettes and other
tobacco products. Once bound to these receptors, Chantix blocks actual nicotine. While
blocking nicotine receptors, it also acts like a weak substitute for nicotine, decreasing
symptoms of withdrawal. (2)
Our study will include 60 tobacco-using patients of all ages above 18 with osseous nonunion,
malunion, established bone infection, or combined diagnoses.
Inclusion Criteria:
- Participants must be a tobacco user and have an osseous nonunion, malunion, infection,
or infected nonunion of the Clavicle, Humerus, Radius, Ulna, Pelvis, Femur, Tibia,
Fibula, or Calcaneus.
- Subjects must be above age 18, be able to understand and give consent, and be
non-pregnant.
Exclusion Criteria:
- Patients unable to understand the protocol, patients allergic to chantix, prisoners,
and pregnant patients will be excluded, and patients with pre-existing psychiatric
illness.
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