POLYSPORIN® OPHTHALMIC OINTMENT STERILE
(bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP)
POLYSPORIN Ophthalmic Ointment (bacitracin zinc and polymyxin B sulfate ophthalmic ointment) is a sterile antimicrobial ointment for ophthalmic use. Each gram contains: bacitracin zinc equivalent to 500 bacitracin units, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and white petrolatum, q. s. Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per mg.
POLYSPORIN Ophthalmic Ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.
Published Studies Related to Polysporin (Bacitracin / Polymyxin B Ophthalmic)
A Randomized Controlled Trial Comparing Mupirocin and Polysporin Triple Ointments in Peritoneal Dialysis Patients: The MP3 Study. [2011.12.01]
Background and objectivesInfectious complications remain a significant cause of peritoneal dialysis (PD) technique failure. Topical ointments seem to reduce peritonitis; however, concerns over resistance have led to a quest for alternative agents...
Long-term follow-up of the Hemodialysis Infection Prevention with Polysporin Ointment (HIPPO) Study: a quality improvement report. [2011.03]
BACKGROUND: Infection is a common and serious complication in hemodialysis patients accessed using central venous catheters (CVCs). Previously, a randomized double-blinded trial (HIPPO [Hemodialysis Infection Prevention With Polysporin Ointment] Study) showed that application of a topical polyantibiotic ointment at the CVC exit site decreased CVC-related infections, including bacteremias and their adverse consequences. Based on this study's results, our institution implemented a policy of routine topical polyantibiotic ointment application for CVC-related infection prophylaxis. The main purpose of this prospective observational study was to determine whether the low rate of CVC-related infection achieved by topical polyantibiotic ointment use during a randomized controlled trial would be observed during long-term prophylaxis as part of routine clinical care... CONCLUSION: Long-term use of topical antibiotic application at CVC exit sites resulted in a sustained decrease in all CVC-related infections. A multidisciplinary effort to monitor and track outcomes allowed safe and effective implementation of a new prophylactic strategy. Copyright (c) 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.
A double-blind, randomized, controlled trial of topical polysporin triple compound versus topical mupirocin for the eradication of colonization with methicillin-resistant Staphylococcus aureus in a complex continuing care population. [2009.09]
BACKGROUND: Intranasal mupirocin or Polysporin Triple (PT) ointment (polymyxin B, bacitracin, gramicidin), in combination with chlorhexidine body washes, have been used for eradicating methicillin-resistant Staphylococcus aureus (MRSA), but no comparative studies have been done... CONCLUSION: Both agents demonstrated poor efficacy and PT was significantly less efficacious than mupirocin at 12 weeks in eradicating MRSA from all sites.
A RANDOMIZED CONTROLLED TRIAL COMPARING MUPIROCIN VERSUS POLYSPORIN TRIPLEa FOR THE PREVENTION OF CATHETER-RELATED INFECTIONS IN PERITONEAL DIALYSIS PATIENTS (THE MP3 STUDY). [2008.01]
BACKGROUND: Peritonitis remains the most serious complication of peritoneal dialysis (PD). Gram-positive organisms are among the most common causes of PD peritonitis; however, recent trends show increasing rates of gram-negative and fungal infections.Discussion: The results of this study will help determine if the use of P3 is superior to mupirocin ointment in the prevention of catheter-related infections and will help guide evidence-based best practices.
A randomized controlled trial comparing mupirocin and polysporin triple ointments
in peritoneal dialysis patients: the MP3 Study. 
double-blind, randomized controlled trial... CONCLUSIONS: This study shows that P(3) is not superior to mupirocin in the
Clinical Trials Related to Polysporin (Bacitracin / Polymyxin B Ophthalmic)
Topical Antibiotics for Prevention of Intensive Care Unit (ICU) Central Line Infections [Not yet recruiting]
Use of Ointments in Prevention of Catheter Related Infections in PD [Recruiting]
Peritoneal dialysis (PD) is used for the treatment of end-stage renal disease in
approximately 25% of patients requiring dialysis in Canada. The most common complication is
bacterial infection or ‘peritonitis’. Peritonitis causes severe acute abdominal pain and may
lead to failure of peritoneal dialysis treatment, hospitalization or death, particularly if
left untreated. Amongst the strategies used to prevent peritonitis, patients are instructed
on the regular use of a prophylactic ointment around the point where the catheter exits from
the body. At the present time most centers in Canada routinely prescribe mupirocin ointment
for use at the exit site, however newer ointments have become available. One such ointment
is Polysporin Triple. The aim of this study is to determine if catheter related infections
can be significantly reduced by the routine application of Polysporin Triple in comparison to
mupirocin ointment. A multi-centre, randomized, double blind, controlled study is proposed.
Participants will be randomized to either mupirocin or Polysporin Triple and followed for 18
months or until the first catheter related infection, death or catheter removal. The
difference in catheter related infection rates will be compared between the two groups. We
anticipate the results of this study will allow clinicians to prescribe the ointment most
likely to reduce infections. By doing so this will reduce the complication rate associated
with peritoneal dialysis and, ultimately improve survival.
Effect of Nitroglycerin Ointment on Mastectomy Flap Necrosis [Not yet recruiting]
Mastectomy flap necrosis (MFN) is a common complication that affects recovery,
reconstructive success and aesthetic outcome. Nitroglycerin (NTG) ointment is a potent
topical vasodilator that increases local blood flow by dilating arteries and veins without
altering the ratio of pre- to post-capillary resistance. There are no studies that evaluate
whether the application of NTG ointment in patients undergoing Skin-sparing mastectomy (SSM)
or nipple-sparing mastectomy (NSM) and immediate reconstruction decreases the rate of
mastectomy flap necrosis.
To evaluate if the post-operative application of NTG ointment improve rates of MFN in
patients undergoing SSM or NSM with immediate breast reconstruction compared to patients
In patients undergoing SSM and immediate breast reconstruction there will be a decrease in
the rate of MFN in those who receive NTG ointment compared to those who receive placebo.
Use of Amnion on Partial Thickness Burns [Recruiting]
To determine if Amnion, used on partial thickness burn injuries would provide an improvement
in rate of healing, pain control and scarring as compared to standard medical treatments.
Hemodialysis Infection Prevention Using Polysporin Ointment With Shower Technique in Satellite Centres Pilot Study [Recruiting]
Background: The investigators developed a Shower Technique protocol (STP) for hemodialysis
(HD) patients with healed central venous catheter (CVC) exit sites, designed to permit
showering but not increase infection risk.
Research question: Is it feasible to conduct a randomized control trial comparing the rate
of CVC related bacteremia (CRB) in adult satellite HD patients using STP versus standard CVC
care alone with 6 month follow up? Study Design: This pilot study is a multi-centre
randomized control trial. Eligible participants will be randomized to STP versus standard
care after meeting predefined criteria to confirm healed tunneled CVC exit site.
Primary Outcome: Feasibility will be determined based on 5 outcome measures: accuracy of
the CRB rate documentation in the satellite setting, percentage of patients screened,
recruited, educated successfully in the STP (intervention arm), and aspects of STP (% of
contaminated patients in the control arm).
Study Setting: In satellite units affiliated with 2 academic and 3 community centres in
south central Ontario, Canada.
Patient Population: Adult satellite HD patients dialyzing via CVC with healed CVC exit
Intervention: STP and standard CVC care; or Control: standard CVC care; Analysis: Each
measure of feasibility has its statistical threshold for success. If the threshold is
reached in 4 of the 5 measures, the full HIPPO SAT study will be deemed feasible.
Discussion: A pilot feasibility study of the larger study is critical due to the potential
challenges associated with recruitment, compliance and contamination.