Selective Mechanical Debridement with Jet Lavage – Efficacy and Future Directions

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Abstract

Abstract
Pressurized wound irrigation is an important adjunct to mechanical debridement of surgical wounds but has limited application in the chronic wound setting. This study assesses a closed bag system designed to capture all fluids and wound effluent associated with the jet lavage treatment. An additional goal was to evaluate the efficacy of pulsatile irrigation for providing selective mechanical debridement. Our results show significant progression of difficult wounds and excellent preparation of the wound bed for subsequent treatment methods.

Introduction
Researchers have identified bacterial biofilm communities as a significant barrier to healing wounds. Mechanical debridement using sharps or using jet lavage are the two primary methods believed to definitively disrupt biofilm and engender a healthy wound bed. Because biofilm has been shown to regenerate within 24 hours of treatment, daily debridements are ideal in early stages of wound healing. Daily debridement with sharps is not always possible for clinical, logistical or financial reasons. Selective Mechanical Debridement with pressurized jet lavage may be the best method available for early wound bed preparation and may be essential in those cases where other methods have not moved the wound out of the chronic inflammation/infection phase.

The Perilav™ system is a medical device consisting of an off the shelf, battery powered pulsatile jet lavage irrigator and a custom fluid containment and collection bag system. The fluid containment bags have been designed for a variety of body or extremity wounds. This system was created to allow a medical provider to perform Selective Mechanical Debridement of an open wound, whether acute or chronic, clean or contaminated, in any setting. Perilav™ was developed by an orthopaedic surgeon with many years of experience with surgical wound treatment including Level 1 orthopaedic traumatology, periprosthetic total joint arthroplasty infections and open chronic wounds and ulcers in older, debilitated patients.

This poster demonstrates the efficacy of regular Selective Mechanical Debridement with pressurized jet lavage and proposes future research opportunities.

Background
In the past five to seven years, research in molecular biology and bacterial biofilm has expanded dramatically. We now know that most bacteria (>80%) produce extracellular polymeric substance, or biofilm, in response to environmental stress. Bacteria reside within that protective biofilm structure and become highly resistant to antibiotics. Mechanical debridement with sharps and pressurized jet lavage are perhaps the only methods available that will disrupt and remove these biofilm communities.

We have also learned that there is a window of approximately six hours in acute, open wounds where the long-term outcome can be significantly improved by these surgical treatments. That six-hour window is related to the bacteria’s ability to create these biofilm cocoons. Even after a surgical debridement, bacteria colonies can return to their pre-treatment levels within approximately 24 hours. Repeated debridements are so critical in the early stages of wound healing and wound bed preparation because they give the patient’s body that extra, necessary help to overcome the initial bioburden, prevent biofilm communities from forming and persisting and enable the body to produce healthy, granulating tissue which can then heal naturally or via subsequent treatments with skin grafts, biologic matrices, etc.

Methods
The preliminary results of the first five cases are described. Patients presented with wounds staged as Class 3 or Class 4 at the initiation of irrigation treatment. Wound types were diagnosed as chronic diabetic foot ulcer (2), pressure decubitus (2) and venous stasis ulcers (1). Patients were included regardless of systemic comorbidities such as diabetes or vascular disease and regardless of whether they were on blood thinners. In four cases, jet lavage treatment was initiated after other methods had been attempted for at least six weeks.

Providers included physicians, physician assistants, nurse practitioners and physical therapists. Providers were trained in the use of jet lavage and the proper positioning of both the patient and the fluid collection bag for irrigation treatments. Providers were instructed to use Tyvek gowns with cap, gloves and masks while treating the patient. In doing so, the bioburden introduced to the treatment area would be extremely low.

Individual treatments were typically performed in 10-15 minutes and could be done easily at the patient’s bedside or in a physician’s outpatient clinic. Daily treatment was recommended but most cases had three to four treatments per week. Average duration of therapy was four weeks.

Modern antiseptic dressings were used after irrigation treatments to cover the wound. Such dressings have been shown to be highly effective in keeping wounds clean for up to 24 hours.

Results
All patients demonstrated substantial improvement of the wound, with edge control and significant progress toward wound closure. All wounds converted to granulation stage from chronic inflammation. No complications were identified in any case and most patients were positive regarding the treatment. No patients complained of pain or irritation from the pulsatile jet lavage.

Two cases were notable in that negative-pressure wound therapy and Santyl had been attempted for eight weeks and healing had not progressed. These wounds were very large, each well over 150 cm/sq. These wounds quickly stabilized using Selective Mechanical Debridement with jet lavage, with loss of slough and smell and progression to rapidly granulating wounds.

Discussion
Mechanical debridement is the hallmark technology for accomplishing early treatment of chronic and infected wounds and takes the form of irrigation and debridement. These are time-tested approaches understood by any practicing surgeon. Sharp debridement is the surgical approach that allows for the removal of any infected, necrotic or contaminated tissues and also allows for the mechanical removal of slough or other products of chronic inflammation. The other limb of this method is irrigation, typified by pressurized jet lavage, and the addition of antiseptic solutions capable of destroying bacterial contamination. Biological mechanisms are important to consider and consist of phenotypic modifications that are focused on survival mechanisms. These survival mechanisms include production of extracellular polymeric substances that become barriers against host immune defenses and changes to metabolic activity that limit antibiotic efficacy. This study introduces a new system that allows providers to take the irrigation method to the outpatient setting.

Several important considerations for this system include: (1) appropriate pressure of the jet lavage under the maximum recommended level of 15psi; (2) a sterile fluid containment bag system of various dimensions designed specifically for limb or body that secures to the skin and catches all irrigants; (3) orifice adhesive that creates a water-tight seal but that is not painful to remove; (4) a technique that is easy and simple and that focuses on removing bio-burden and making the wound as clean as possible. This study demonstrates that these design goals were accomplished. More experience will refine our current knowledge.

We find that anesthesia is not needed for most patients undergoing jet lavage. The removal of debris and conversion to healthy granulation occurs quickly in several days in all settings, including vascular abnormalities and chronic debility. We cannot yet recommend the exact level of early wound bed preparation that allows conversion to other treatments such as placement of dermis allograph transplants. We have not yet established when early daily wound irrigation may be converted from daily to less intense treatment occurring every three to four days. However, our current evaluation validates that outpatient irrigation and debridement with pressurized jet lavage is a powerful treatment method. Continued study and documentation will enable us to provide evidence for further recommendations.

Conclusion
Our initial cases showed remarkable outcomes. We demonstrated that Selective Mechanical Debridement with jet lavage using the Perliav™ system is both well-tolerated by the patient and effective at transitioning wounds out of the chronic inflammation stage. The fluid collection bag was easy for providers to apply and very effective at keeping all fluids contained during and after each treatment. We demonstrated that Selective Mechanical Debridement with jet lavage could be done by a variety of provider types in any outpatient setting.

We recognize that in the outpatient setting going to the clinic every day can become somewhat impractical. Once the wound bed has been prepared sufficiently using Selective Mechanical Debridement with jet lavage, the patient could then be transitioned to alternate treatment methodologies such as negative-pressure wound therapy, hydrogels or collagenases, biologics or a skin graft based on physician and patient preference.

Subsequent studies could include comparing Selective Mechanical Debridement with jet lavage to negative-pressure wound therapy or comparing Selective Mechanical Debridement with jet lavage to use of traditional collagenases or biologics.

Future scientific research could examine the efficacy of Selective Mechanical Debridement with jet lavage on breaking down biofilm as well as the efficacy of using Selective Mechanical Debridement with jet lavage with irrigants other than sterile saline.


References
1. Trengove NJ(1), Stacey MC, MacAuley S, Bennett N, Gibson J, Burslem F, Murphy G, Schultz G. Analysis of the acute and chronic wound environments: the role of proteases and their inhibitors. Wound Repair Regen. 1999 Nov-Dec;7(6):442-52.
2. Yang Q(1), Phillips PL, Sampson EM, Progulske-Fox A, Jin S, Antonelli P, Schultz GS. Development of a novel ex vivo porcine skin explant model for the assessment of mature bacterial biofilms.Wound Repair Regen. 2013 Sep-Oct;21(5):704-14. doi: 10.1111/wrr.12074. Epub 2013 Aug 8.
3. Hu H(1), Sleiman J(1), Johani K(1), Vickery K(1). Hypochlorous Acid Versus Povidone-Iodine Containing Irrigants: Which Antiseptic is More Effective for Breast Implant Pocket Irrigation? Aesthet Surg J. 2017 Nov 28. doi: 10.1093/asj/sjx213. [Epub ahead of print]
4. Schultz G, Bjarnsholt T, James GA, Leaper DJ, McBain AJ, Malone M, Stoodley P, Swanson T, Tachi M, Wolcott RD; Global Wound Biofilm Expert Panel. Consensus guidelines for the identification and treatment of biofilms in chronic nonhealing wounds. Wound Repair Regen. 2017 Sep 29. doi: 10.1111/wrr.12590. [Epub ahead of print]
5. Wu H, Moser C, Wang HZ, Høiby N, Song ZJ. Strategies for combating bacterial biofilm infections. Int J Oral Sci. 2015 Mar 23;7(1):1-7. doi: 10.1038/ijos.2014.65.
6. Cooper RA, Bjarnsholt T, Alhede M. Biofilms in wounds: a review of present knowledge. J Wound Care. 2014 Nov;23(11):570, 572-4, 576-80 passim. Doi.10.12968/jowc.2014.23.11.570.
7. Bjarnsholt T(1), Alhede M, Alhede M, Eickhardt-Sørensen SR, Moser C, Kühl M, Jensen PØ, Høiby N. The in vivo biofilm.Trends Microbiol. 2013 Sep;21(9):466-74. doi: 10.1016/j.tim.2013.06.002. Epub 2013 Jul 2.
8. Fazli M(1), Bjarnsholt T, Kirketerp-Møller K, Jørgensen A, Andersen CB, Givskov M, Tolker-Nielsen T. Quantitative analysis of the cellular inflammatory response against biofilm bacteria in chronic wounds.Wound Repair Regen. 2011 May-Jun;19(3):387-91. doi:10.1111/j.1524-475X.2011.00681.x. Epub 2011 Apr 21.
9. Høiby N(1), Bjarnsholt T, Givskov M, Molin S, Ciofu O. Antibiotic resistance of bacterial biofilms.Int J Antimicrob Agents. 2010 Apr;35(4):322. doi: 10.1016/ j.ijantimicag. 2009.12.011. Epub 2010 Feb 10.
10. Kirketerp-Møller K(1), Jensen PØ, Fazli M, Madsen KG, Pedersen J, Moser C, Tolker-Nielsen T, Høiby N, Givskov M, Bjarnsholt T. Distribution, organization, and ecology of bacteria in chronic wounds.J Clin Microbiol. 2008 Aug;46(8):2717-22. doi: 10.1128/JCM.00501-08. Epub 2008 May 28.

11. Macià MD, Del Pozo JL, Díez-Aguilar M, Guinea J. Microbiological diagnosis of biofilm-related infections.Enferm Infecc Microbiol Clin. 2017 May 27. pii: S0213-005X(17)30138-6. doi:10.1016/j.eimc.2017.04.006

12. del Pozo JL(1), Patel R. The challenge of treating biofilm-associated bacterial infections Clin Pharmacol Ther. 2007 Aug;82(2):204-9. Epub 2007 May 30.
13. Howe TS(1), Ehrlich GD, Koh JS, Ng AC, Costerton W. A case of an atypical femoral fracture associated with bacterial biofilm--pathogen or bystander? Osteoporos Int. 2013 May;24(5):1765-6. doi: 10.1007/s00198-012-2222-4. Epub 2012 Nov 15.
14. Palmer M(1), Costerton W, Sewecke J, Altman D. Molecular techniques to detect biofilm bacteria in long bone nonunion: a case report. Clin Orthop Relat Res. 2011 Nov;469(11):3037-42. doi: 10.1007/s11999-011-1843-9.
15. Costerton W(1), Veeh R, Shirtliff M, Pasmore M, Post C, Ehrlich G.J The application of biofilm science to the study and control of chronic bacterial infections. Clin Invest. 2003 Nov;112(10):1466-77.
16. Phillips PL(1), Yang Q, Schultz GS. The effect of negative pressure wound therapy with periodic instillation using antimicrobial solutions on Pseudomonas aeruginosa biofilm on porcine skin explants.Int Wound J. 2013 Dec;10 Suppl 1:48-55. doi: 10.1111/iwj.12180.
17. Phillips PL, Yang Q, Davis S, Sampson EM, Azeke JI, Hamad A,Schultz GS. Antimicrobial dressing efficacy against mature Pseudomonas aeruginosa biofilm on porcine skin explants. Int Wound J. 2015 Aug;12(4):469-83. doi: 10.1111/iwj.12142. Epub 2013 Sep 13.
18. Johani K, Malone M, Jensen SO, Dickson HG, GosbellIB, Hu H, Yang Q, Schultz G, Vickery K. Evaluation of short exposure times of antimicrobial wound solutions against microbial biofilms: from in vitro to in vivo. J Antimicrob Chemother. 2017 Nov 18. doi: 10.1093/jac/dkx391. [Epub ahead of print]
19. Johani K, Malone M, Jensen S, Gosbell I, Dickson H, Hu H, Vickery K. Microscopy visualisation confirms multi-species biofilms are ubiquitous in diabetic foot ulcers. Int Wound J. 2017 Dec;14(6):1160-1169. doi: 10.1111/iwj.12777. Epub 2017 Jun 23.
20. Hu H(1), Johani K(2), Gosbell IB(3), Jacombs AS(1), Almatroudi A(4), Whiteley GS(5), Deva AK(1), Jensen S(6), Vickery K(7). Intensive care unit environmental surfaces are contaminated by multidrug-resistant bacteria in biofilms: combined results of conventional culture, pyrosequencing, scanning electron microscopy, and confocal laser microscopy.J Hosp Infect. 2015 Sep;91(1):35-44. doi: 10.1016/j.jhin.2015.05.016. Epub 2015 Jun 25.
21. Percival SL, Mayer D, Malone M, Swanson T, Gibson D, Schultz G. Surfactants and their role in wound cleansing and biofilm management. J Wound Care. 2017 Nov 2;26(11):680-690. doi: 10.12968/jowc.2017.26.11.680.
22. Malone M, Johani K, Jensen SO, Gosbell IB, Dickson HG, Hu H, Vickery K. Next Generation DNA Sequencing of Tissues from Infected Diabetic Foot Ulcers.EBioMedicine. 2017 Jul;21:142-149. doi: 10.1016/j.ebiom.2017.06.026. Epub 2017 Jun 27.
23. Malone M, Bowling FL, Gannass A, Jude EB, Boulton AJ. Deep wound cultures correlate well with bone biopsy culture in diabetic foot osteomyelitis. Diabetes Metab Res Rev. 2013 Oct;29(7):546-50. doi: 10.1002/dmrr.2425.
24. Kolpen M, Mousavi N, Sams T, Bjarnsholt T, Ciofu O, Moser C, Kuhl M, Høiby N, Jensen PØ. Reinforcement of the bactericidal effect of ciprofloxacin on Pseudomonas aeruginosa biofilm by hyperbaric oxygen treatment. Int J Antimicrob Agents. 2016 Feb;47(2):163-7. doi: 10.1016/j.ijantimicag.2015.12.005. Epub 2015 Dec 29.
25. Bjarnsholt T, Alhede M, Jensen PØ, Nielsen AK, Johansen HK, Homøe P, Høiby N, Givskov M, Kirketerp-Møller K. Antibiofilm Properties of Acetic Acid.Adv Wound Care (New Rochelle). 2015 Jul 1;4(7):363-372.
26. Johansen LK(1), Koch J, Frees D, Aalbæk B, Nielsen OL, Leifsson PS, Iburg TM, Svalastoga E, Buelund LE, Bjarnsholt T, Høiby N, Jensen HE. Pathology and biofilm formation in a porcine model of staphylococcal osteomyelitis.J Comp Pathol. 2012 Aug-Oct;147(2-3):343-53. doi: 10.1016/j.jcpa.2012.01.018.
27. Christensen LD(1), van Gennip M, Jakobsen TH, Alhede M, Hougen HP, Høiby N, Bjarnsholt T, Givskov M. Synergistic antibacterial efficacy of early combination treatment with tobramycin and quorum-sensing inhibitors against Pseudomonas aeruginosa in anintraperitoneal foreign-body infection mouse model.J Antimicrob Chemother. 2012 May;67(5):1198-206. doi: 10.1093/jac/dks002. Epub 2012 Feb 1.
28. Høiby N(1), Ciofu O, Johansen HK, Song ZJ, Moser C, Jensen PØ, Molin S, Givskov M, Tolker-Nielsen T, Bjarnsholt T. The clinical impact of bacterial biofilms. Int J Oral Sci. 2011 Apr;3(2):55-65. doi: 10.4248/IJOS11026.
29. Rybtke MT(1), Jensen PØ, Høiby N, Givskov M, Tolker-Nielsen T, Bjarnsholt T. The implication of Pseudomonas aeruginosa biofilms in infections. Inflamm Allergy Drug Targets. 2011 Apr;10(2):141-57.
30. Rudkjøbing VB, Thomsen TR, Xu Y, Melton-Kreft R, Ahmed A, Eickhardt S, Bjarnsholt T, Poulsen SS(6), Nielsen PH(1), Earl JP, Ehrlich GD, Moser C. Comparing culture and molecular methods for the identification of microorganisms involved in necrotizing soft tissue infections. BMC Infect Dis. 2016 Nov 8;16(1):652.
31. Kragh KN, Hutchison JB, Melaugh G, Rodesney C, Roberts AE, Irie Y, Jensen PØ, Diggle SP, Allen RJ, Gordon V, Bjarnsholt T. Role of Multicellular Aggregates in Biofilm Formation. MBio. 2016 Mar 22;7(2):e00237. doi: 10.1128/mBio.00237-16.
32. Cao B, Christophersen L, Thomsen K, Sønderholm M, Bjarnsholt T, Jensen PØ, Høiby N, Moser C. Antibiotic penetration and bacterial killing in a Pseudomonas aeruginosa biofilm model.J Antimicrob Chemother. 2015 Jul;70(7):2057-63. doi: 10.1093/jac/dkv058. Epub 2015 Mar 18.
33. Eickhardt S(1), Kragh KN(2), Schrøder S(3), Poulsen SS(4), Sillesen H(5), Givskov M(6), Høiby N(2), Bjarnsholt T(2), Alhede M(2). Autofluorescence in samples obtained from chronic biofilm infections--"all that glitters is not gold".Pathog Dis. 2015 Jun;73(4). pii: ftv012. doi: 10.1093/femspd/ftv012. Epub 2015 Feb 5.
34. Alhede M(1), Bjarnsholt T(2), Givskov M(3), Alhede M(2). Pseudomonas aeruginosa biofilms: mechanisms of immune evasion. Adv Appl Microbiol. 2014;86:1-40. doi: 10.1016/B978-0-12-800262-9.00001-9.
35. Bjarnsholt T(1), Ciofu O, Molin S, Givskov M, Høiby N. Applying insights from biofilm biology to drug development - can a new approach be developed? Nat Rev Drug Discov. 2013 Oct;12(10):791-808. doi: 10.1038/nrd4000.
36. Høiby N(1), Ciofu O, Johansen HK, Song ZJ, Moser C, Jensen PØ, Molin S, Givskov M, Tolker-Nielsen T, Bjarnsholt T. The clinical impact of bacterial biofilms. Int J Oral Sci. 2011 Apr;3(2):55-65. doi: 10.4248/IJOS11026.
37. Burmølle M(1), Thomsen TR, Fazli M, Dige I, Christensen L, Homøe P, Tvede M, Nyvad B, Tolker-Nielsen T, Givskov M, Moser C, Kirketerp-Møller K, Johansen HK, Høiby N, Jensen PØ, Sørensen SJ, Bjarnsholt T. Biofilms in chronic infections - a matter of opportunity - monospecies biofilms in multispecies infections.FEMS Immunol Med Microbiol. 2010 Aug;59(3):324-36. doi: 10.1111/j.1574-695X.2010.00714.x. Epub 2010 Jun 7.
38. Bjarnsholt T(1), Kirketerp-Møller K, Jensen PØ, Madsen KG, Phipps R, Krogfelt K, Høiby N, Givskov M. Why chronic wounds will not heal: a novel hypothesis.Wound Repair Regen. 2008 Jan-Feb;16(1):2-10. doi:10.1111/j.1524-475X.2007.00283.x.
39. Bjarnsholt T(1), Kirketerp-Møller K, Kristiansen S, Phipps R, Nielsen AK, Jensen PØ, Høiby N, Givskov M. Silver against Pseudomonas aeruginosa biofilms.APMIS. 2007 Aug;115(8):921-8.
40. Bjarnsholt T(1), Givskov M. Quorum-sensing blockade as a strategy for enhancing host defences against bacterial pathogens. Philos Trans R Soc Lond B Biol Sci. 2007 Jul 29;362(1483):1213-22.

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