Rafael Carrion, MDAssociate Professor of Urology

Program DirectorDirector of Research

Saving the Cavernous Spaces after Infection

Dilemma with Conservative Therapy Limited penetration of

oral or systemic antibiotics to area containing the prosthesis– Scar tissue surrounds the

prosthetic parts as a response to walling off a foreign body

– Bacterial Biofilm

Biofilm Biofilms occur when bacteria

and/or other microbes attach to surfaces and surround themselves with protective extracellular polymeric substances (EPS).

Cells communicating with each other, coordinate expression of certain genes, and organizing their activities.

Forming a 'resilient refugia'for bacteria; one that is able to resist natural stressors, and most antimicrobial agents.

Biofilm Bacteria in biofilms can

evolve as a result of starvation or other external pressures.

Significant problem in engineered systems (pipelines) and biomedical processes (e.g. hospital-acquired infections, persistent infections, biofouling of implant devices) (Kraigsleyand Finkley, 2009)

Overview

Modern penile implants provide a predictable/reliable treatment of erectile dysfunction (ED) despite the development of less-invasive therapies. – Patient and partner satisfaction is highest with a

penile implant among all of the treatments for ED

Procedure can be complicated by infection

Incidence Infection associated with penile implants is

– Thought to be due to bacterial colonization during surgery

Infection rates vary from 0.6% to 8.9% for primary procedures

Pre-Coated Implants: Incidence of up to 13.3% associated with revision surgery

Post-Coated Implants: 1.77% infection rate compared with 3.09% infection rate in a control group of non-coated implants

Coated + no-skin-touch group = 0.7%

Offenders Coagulase-negative Staphylococcus comprises 58%

of infections Staphylococcus Lugdunensis, Epidermitis Pseudomonas aeruginosa Serratia marcescens Enterococcus Proteus mirabilis MRSA Candida albicans Bacteroides fragilis

Removal– Then when or if to place implant in the future

Salvage Prosthesis– Malleable– Inflatable

Stimulan

Gross, M; Levine, L; Carrion, R; Eid, J, Martinez, D; Perito, P; Munariz, R. ISSM Abstract #045, Improved Infection outcomes after mulcahy salvageProcedure and replacement of infected IPP with malleable prosthesis.

Choices with a Clinical Penile Prosthetic Infection:

Risk Factors: Comorbidities, Surgical History

3X infection rate in diabetic population

Immunosuppression

Revision surgery

Does this affect your decision for salvage choice?

Consequences

Removal– Negative changes to Morphology– Raises difficulty for future implantation

Salvage Prosthesis– Preserves morphology and erectile function

Stimulan– Preserves morphology– Preserves ease of future implantation

Bio-inert Cast CaSO4

Widely used – Dentistry

– Orthopedics (Osteo-induction)

– Infection Osteomyelitis

Biocompatible material

Completely resorbed following implantation

Does not evoke a significant host response

Cast Content

Addition of Anti-microbial to mixture for local infection treatment

Release of pharmacologic agent from a carrier isdirectly proportional to dissolution of the CaSO4 ( Based on experimental calculations approximately -16.7% volume/week)

Limitations

Variation in inflammatory period based on risk factors and severity of infection

Addition of Abx increases diffusion coefficient

Gradual loss of volume still allows for some volume contracture

Not candidates for immediate salvage– Failed immediate

salvage – Septicaemia

THE CARRION CAST: AN UPDATE ON THE USAGE OF THE INTRACORPORAL ANTIMICROBIAL DOPED SPACER FOR THE TREATMENT OF PENILE IMPLANT INFECTION

Daniel R. Martinez, Eihab Alhammali, Justin Emtage, Justin Parker and Rafael E. CarrionDepartment of Urology, University of South Florida, Tampa, Florida

Updated series “Carrion Cast”– Antimicrobial spacer – Maintains size– Treating infection– Bridging gap between

explant and reimplant

5/2012 - 2/2014 9 cases

– 5 Coloplast Genesis SemirigidPenile Prosthesis (SRPP)

– 2 Coloplast Titan Inflatable Penile Prosthesis (IPP)

– 2 narrow SRPP’s• Size range 17cm to 23cm

CaSO4 cast size – 20-30cc, split between corpora

Serum calcium, vancomycinand tobramycin levels stable

THE CARRION CAST: AN UPDATE ON THE USAGE OF THE INTRACORPORAL ANTIMICROBIAL DOPED SPACER FOR THE TREATMENT OF PENILE IMPLANT INFECTION

Daniel R. Martinez, Eihab Alhammali, Justin Emtage, Justin Parker and Rafael E. CarrionDepartment of Urology, University of South Florida, Tampa, Florida

Time to reimplantation– 6-18 weeks

• 6 weeks cast dissolves All had prosthesis

replaced – 1 SRPP– 3 IPP’s– 2 narrow SRPP’s– 1 narrow IPP

• Size range 17cm -20cm

Mean loss prosthesis length 1.1cm

Average penile length maintained 95%

THE CARRION CAST: AN UPDATE ON THE USAGE OF THE INTRACORPORAL ANTIMICROBIAL DOPED SPACER FOR THE TREATMENT OF PENILE IMPLANT INFECTION

Daniel R. Martinez, Eihab Alhammali, Justin Emtage, Justin Parker and Rafael E. CarrionDepartment of Urology, University of South Florida, Tampa, Florida

Initial Slurry injections

Active Research

8 50cc cylindrical casts were placed in 100cc of saline

Maintained at 78° F

Weighed weekly for 7 weeks

Ongoing0,00

10,00

20,00

30,00

40,00

50,00

60,00

1 2 3 4 5 6 7 8

100% CaSO4

80/20 SO4/PO4

60/40 SO4/PO4

50/50 SO4/PO4

40/60 SO4/PO4

20/80 SO4/PO4

100 CaPO4

weeks

cc

Infections still pose a risk for penile prosthetic surgery Management choices can be challenging

and have negative outcomes Development of a “Spacer” can provide a

safe option to manage the acute pathology and preserve optimal eventual prosthetic outcome.

Conclusion

References Kraigsley, A. M. and Finkel, S. E. (2009), Adaptive evolution in single species bacterial biofilms. FEMS

Microbiology Letters, 293: 135–140. doi: 10.1111/j.1574-6968.2009.01526.x

Burrows LL, Khoury AE. Infection of medical devices. In: Encyclopedia of biomaterials and biomedical engineering. New York: Marcel Dekker Inc; 2001. p. 839-848.

Costerton B, Cook G, Shirtliff M, Stoodley P, Pasmore M. Biofilms, biomaterials, and device-related infections. In: Ratner BD, Hoffman AS, Schoen FJ, Lemons JE, editors. Biomaterials science: An introducion to materials in medicine, 2nd edition. San Francisco, CA: Elsevier Academic Press; 2004. p. 345-354.

Donlan RM. Biofilms and device-associated infections. Emerging Infect Dis 2001; 7(2): 277-281.

Thomas MV, Puleo DA. Calcium sulfate: Properties and clinical applications. J Biomed Mater Res Part B ApplBiomater. 2009;88(2):597-610.

Harik NS, Smeltzer MS. Management of acute hematogenous osteomyelitis in children. Expert Rev Anti Infect Ther. 2010;8(2):175-81.

Thomas MV, Puleo DA, Al-sabbagh M. Calcium sulfate: a review. J Long Term Eff Med Implants. 2005;15(6):599-607.

Tay BK, Patel VV, Bradford DS. Calcium sulfate- and calcium phosphate-based bone substitutes. Mimicry of the mineral phase of bone. Orthop Clin North Am. 1999;30(4):615-23.

Guo H, Wei J, Liu CS. Development of a degradable cement of calcium phosphate and calcium sulfate composite for bone reconstruction. Biomed Mater. 2006;1(4):193-7.

Daniel M, Chessman R, Al-Zahid S, et al. Biofilm Eradication With Biodegradable Modified-Release Antibiotic Pellets: A Potential Treatment for Glue Ear. Arch Otolaryngol Head Neck Surg. 2012;138(10):942-949. doi:10.1001/archotol.2013.238.

Kostenko V, Lyczak J, Turner K, Martinuzzi RJ. Impact of silver-containing wound dressings on bacterial biofilm viability and susceptibility to antibiotics during prolonged treatment. Antimicrob Agents Chemother. 2010;54(12):5120-31.

References Fallon B., Ghanem H. (1990) Sexual performance and satisfaction with penile prostheses in impotence of

various etiologies. Int J Imp Res 2: 35–42.

Bandyk D.F., Bergamine T.M., Kinney E.V., Seabrook G.R., Towne J.B. (1991) In-situ replacement of vascular prostheses infected with bacterial biofilms. J Vasc Surg 13: 575–583.

Brant M.D., Ludlow J.K., Mulcahy J.J. (1996) The prosthesis salvage operation: immediate replacement of the infected penile prosthesis. J Urol 155: 155–157

Carson C.C., Robertson C.N. (1988) Late hematogenous infection of penile prostheses. J Urol 139: 50–52.

Dietzen C.J., Lloyd L.K. (1992) Complications of intracavernous injections and penile prostheses in spinal cord injured men. Arch Phys Med Rehab 73: 652–655.

Fishman I.J., Scott F.B., Selim A.M., Nguyen T.A. (1997) The rescue procedure: an alternative for managing an infected penile prosthesis. Contemp Urol 11: 77–80.

Knoll L.D. (1998) Penile prosthesis infection: management by delayed and immediate salvage technique. Urology 52: 287–290

Mulcahy J.J. (2000b) Surgical management of penile prosthesis complications. Int J Imp Res 12(Suppl 4): 108–111.

Dorozhkin SV. Biocomposites and hybrid biomaterials based on calcium orthophosphates. Biomatter. 2011;1(1):3-56.

Siegrist T.C., Kwon E.O., Fracchia J.A., Eid J.F. (2008) No touch technique: a novel technique for reducing postoperative infections in patients receiving multicomponent inflatable penile

Carson C.C. (2004) Efficacy of antibiotic impregnation of inflatable penile prostheses in decreasing infection in original implants. J Urol 171: 1611–1614.prostheses. J Urol 179(Suppl): 404–404.