Closed Pulse Irrigation: A Better Pulse Lavage Delivery System for Wound Debridement and Biofilm Management

When Celeste Bell was declared free of anal cancer a few years ago, she was left with a painful reminder from the more than 30 radiation and chemotherapy treatments that cured her: a large, open wound (measuring 4 cm x 5 cm) that was very tender, difficult to keep clean, and remained chronic. Early in 2014, the recent retiree found herself spending most of her time at Briarwood Health Care Center in Denver instead of gardening, attending ballgames, and spending hours on end with her grandchildren – as she would have hoped. Beginning in late February of that year, wound care specialists at Briarwood began treating Bell’s wound with the Closed Pulse Irrigation^® Wound Therapy System (CPI^®; PulseCare^® Medical, North Andover, MA) – a total containment solution for pulse lavage that allows for safe, selective hydrodebridement at the bedside and/or in the outpatient clinic. CPI provides a new paradigm for biofilm management in wound care by focusing on hydromechanical disruption and removal of wound surface biofilm, which can alter the trajectory of a chronic wound to one of healing progression. Improvement in pain levels, wound sepsis, healing time, limb preservation, antibiotic conservation, and patient satisfaction are also experienced with CPI utilization within a cost-effective framework. 

After the first few daily CPI treatments, Mrs. Bell experienced significantly less pain, less exudate, and odor. Within four months of CPI treatment she was discharged with her irradiated wound completely healed by secondary intention. A year later, she remains healed and is enjoying an active retirement.

Mrs. Bell’s story is far from unique. Each day chronic wounds impact quality of life for many patients despite the use of traditional measures. Many times, wound care treatment modalities are improperly used — either in the wrong sequence during the healing process or they are just not effective enough for specific types of wounds. For many patients like Mrs. Bell, effective wound treatment begins with a clean wound bed. The critical first step in wound healing is debridement. Also important is frequent, effective selective hydro-debridement, which is the key to this new paradigm, to repeatedly remove only the bad actors — bacteria, necrotic tissue, and debris — while allowing the healthy tissue to remain intact. Maintaining a clean, healthy, granulating wound bed substantially reduces the risk of wound sepsis and sets the stage for normal healing progression. This article describes the presence of bacterial biofilm as an antagonist to normal healing pathways and introduces the CPI Wound Therapy System as a new “bio-physical” method for biofilm management in wound care.^1,2

Wound Biofilm

Increasing evidence over the past 10 years has shown biofilm is detrimental to wound healing. Loss of integument exposes vulnerable tissue to planktonic (free-floating) bacteria and environmental debris. These planktonic bacteria don’t exist on the wound’s surface for very long before they vigorously attach and develop into a synergistic biofilm that continuously repopulates to cover the entire wound surface, becoming a mature biofilm.^3-5 Bacterial attachment to wound surfaces is the trigger for a cellular change from the planktonic phenotype to the biofilm phenotype. Mature biofilm becomes a highly organized, three-dimensional structure communicating and functioning as one unified multispecies organism that’s protected by an extracellular matrix, yet is capable of releasing more planktonic bacteria into the wound bed to re-establish and perpetuate the mature biofilm colony onto wound surfaces. Re-establishment of mature biofilm aggregates occurs easily when less frequent debridement procedures leave remnants of biofilm behind on wound surfaces. We also know that biofilm defense mechanisms are highly resistant to antibiotics, topical antiseptics, and the host immune system.⁶ Due to the difficulty with standard culturing techniques, we have significantly underestimated the presence of bacterial biofilm in sampled chronic wounds. Studies using advanced scanning confocal electron microscopy show at least 60% of chronic wounds contain biofilm.^2,7 Often undetected, bacterial biofilms induce an environment conducive to their own protection and create  “unregulated inflammation” due to their virulence and pathogenicity that disrupts normal healing pathways by secreting harmful proteases, collagenases, and other bacterial toxins within the wound bed.

Recent History of Pulse Lavage

Once a very common and successful wound therapy, pulse lavage with suction, (PLWS) was substantially curtailed after being linked to a serious outbreak of multidrug resistant bacteria at Johns Hopkins Hospital, Baltimore, in 2003.⁸ This publication revealed that (open) PLWS produces uncontrolled splash, splatter, and aerosolization of potentially infectious organisms that can contaminate the environment even after the area has been cleaned.⁸ Traditional (open) PLWS performed outside of a specialized treatment room fell out of favor due to potential serious risks of environmental contamination and the requirements for time-consuming clean up after each treatment.

Mechanisms of CPI Wound Therapy

Fast-forward to 2015. PulseCare Medical has developed the first totally contained pressurized wound irrigation system with documented safety studies performed at Wake Forest University.^9,10 The CPI Wound Therapy System remains one of the safest, most efficacious, and cost-effective methods for performing bedside pressurized irrigation available,^9-11 even in a semi-private room or at home. Complete enclosure of the wound during treatment allows collection of all contaminated fluids and aerosolized particles by gravity without the need for suction or contact. This new safety feature brings versatility, allowing CPI to be performed wherever the patient is — be it the bedside, in a wheelchair, an outpatient facility, or in one’s home. In addition, many patients describe CPI treatment as less painful than (open) PLWS. Economically, CPI eliminates¹⁰ the need for high-cost treatment rooms, suction apparatus, and daily transportation.

Redefining Biofilm Management With CPI

Mature biofilm remnants that adhere to wound surfaces even after sharp debridement are poised to reform mature biofilm aggregates. These microbes often go unseen by the naked eye¹² and may persist for months or years within the wound bed. Currently, much scientific work is directed towards using antibiotics and developing new pharmaceuticals to kill biofilm bacteria or to prevent attachment, which triggers the biofilm phenotype (yet physical methods of removal continue to be the most reliable).  Garth James, PhD, associate research professor, chemical and biological engineering, medical biofilm laboratory manager, Montana State University’s Center for Biofilm Engineering, has stated that mechanical “physical” methods of removing bacterial biofilm are most reliable in the long run. CPI is introduced as a “biophysical” antibiofilm strategy that overcomes the limitations of other antibiofilm methods: surgery, sharps, antibiotics, or topical pharmaceuticals.

In 2014, Rodheaver and Ratiff¹³ further define wound cleansing as “the removal of surface contaminates, bacteria, and remnants of dressings from the wound surface and surrounding skin.” This  “biophysical” intervention is best implemented using a mechanical irrigator to consistently pressurize and deliver irrigation saline at selective forces between 8-15 pounds per square inch.^14,15 Level I clinical studies and safety studies demonstrate pressurized irrigation used in conjunction with the CPI wound irrigation bag is effective, safe and cost effective, with high patient-satisfaction scores.^9-11,14,16 Using a biophysical method such as CPI decreases dependence and overuse of antibiotics and prevents spreading biofilm antibiotic resistance, which bolsters antimicrobial resistant species and antimicrobial heterogeneity states (eg, growing, stress-adapted, dormant, inactive).¹ CPI overcomes the common limitations of serial surgical and nonsurgical sharp debridement, which leaves persistent biofilm fragments in the wound and in tunneled areas after treatment. Leaving remnants of biofilm fragments in the wound allows biofilm regeneration to occur usually within 10-24 hours.^3,4 Frequent use of ineffective biofilm treatments such as antibiotics or serial surgical or sharp debridement promotes either more drug resistance due to “overuse” of antibiotics or “over-debridement” of wounds due to ineffective serial surgical or sharp debridement. Selective mechanical debridement appears to be an essential and reliable strategy in the eradication of wound biofilm without trauma to normal tissues.^1,5,14

Wound care clinicians no longer have the luxury of relying on the use of repeated surgical, sharps debridement, or antibiotics to treat chronic, nonhealing wounds. Multidrug bacterial resistance is here and the Centers for Disease Control and Prevention has sounded the alarm concerning the overuse of antibiotics. Debridement strategies (eg, selective hydrodebridement using CPI) can and should be a first line of defense in wound care. Management of biofilm should be an integral “must do” component to achieve successful wound bed preparation or secondary intention healing. Wound clinic providers should begin integration of new biofilm management strategies into protocols and stay informed of new biofilm management products. ^17,18 

Patrick V. Marasco, Jr., MD, FACS, has been a practicing plastic surgeon for more than 20 years. He completed his general surgery training at Michigan State University and plastic surgery training at Wake Forest University. During his residency at Wake Forest University, Dr. Marasco worked on early negative pressure research with Louis Argenta, MD, and Michael Morykwas, PhD, the inventors of V.A.C.^® Therapy for Wounds. Dr. Marasco is the founder of PulseCare Medical and Inventor of the patented Closed Pulse Irrigation^® (CPI) Wound Therapy System.

References

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2. Metcalf DG, Bowler PG. Biofilm delays wound healing: A review of the evidence. Burns and Trauma Infection Prevention, ConvaTec, Global Development Centre, First Avenue, Deeside Industrial Park, Flintshire CH5 2NU, United Kingdom.2013;1(1): 5-12.

3. Davis SC, Ricotti C, Cazzaniga A, Welsh E, Eaglstein WH, Mertz PM. Microscopic and physiologic evidence for biofilm associated wound colonization in vitro. Wound Repair Regen. 2008;16(1):23-29.

4. Harrison-Balestra C, Caazzanga AL, Davis S, et.al. A wound-isolated Pseudomonas aeruginosa grows a biofilm in vitro within 10 hours and is visualized by light microscopy. Dermatol Surg. 2003;29(6):631-5.

5. Keblish DJ, Demaio M. Early pulsatile lavage for the decontamination of combat wounds: Historical review and point proposal. Mil Med. 1998;163(12):844-6.

6. Kiketerp-Meller K, Jenson PO, Fazli M, Madsen KG, Pederson J, Moser C, et al. Distribution organization and ecology of bacteria in chronic wounds. J Clin Microbiol. 2008;46:2712-22.

7. James GA, Swogger E, Wolcott R, et al. Biofilms in chronic wounds. Wounds Repair Regen. 2008; 16:37-44.

8. Maragakis LL, Cosgrove SE, Song C, et al. An outbreak of multi-drug resistant Acinetobacter baumannii associated with pulsatile lavage wound treatment. JAMA. 2004;292(4): 3006-11.

9. Marasco PV, Sanger C, Gordon SE, Simpson J, Morykwas M, Marks M. Prevention of aerosol contamination during pulsatile lavage. Plast Reconstr Surg. 2005;(Abstract Supplement): 32.

10. Angabaldo J, Sanger C, Marks M. Prevention of projectile and aerosol contamination during pulsatile lavage irrigation using a wound irrigation bag. Wounds. 2008;20(7):167-170.

11. Mak SS, Lee MY, Cheung JS, Choi KC, Chung TK, Wong TW, Lam KY, Lee DT. Pressurised irrigation versus swabbing method in cleansing wounds healed by secondary intention: A randomised controlled trial with cost-effectiveness analysis. Int J of Nurs Stud. 2015;52(1):88-101. doi: 10.1016/j.ijnurstu.2014.08.005. Epub 2014 Aug 22.

12. Serena T, Robson MC, Cooper, DM, Ignatius J, et al, Lack of reli   ability of clinical/visual assessment of chronic wound infection: The incidence of biopsy-proven infection in venous leg ulcers. Wounds. 2006;18(7):197-202.

13. Rodheaver GT, Ratliff CR. Wound Cleansing, Wound Irrigation, Wound Disinfection. In Chronic Wound Care: The Essentials. 2014. HMP Publications, Malvern, PA.

14. Bergstrom N, Bennett M, Carlson CE, et al. Treatment of pressure ulcers. Clinical practice guideline No. 15. Rockville, MD: US Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research. AHCPR Publication No. 95-0652. 1994.

15. Granick MS, Tenenhaus M, Knox K, Ulm JP. Comparison of wound irrigation and tangential hydrodissection in bacterial clearance of contaminated wounds: Results of a randomized controlled clinical study. OWM. 2007;53(4):64-6, 68-70, 72.

16. Ho CA, Benistel T, Wang X, Bogie KM. Pulsatile lavage for the enhancement of pressure ulcer healing: A randomized controlled trial. Phys Ther. 2012;92:38-48.

17. Hurlow J, Couch K, Laforet K, Bolton L, Metcalf D, Bowler P. Clinical biofilms: A challenging frontier in wound care. Adv Wound Care. 2015;4(5):295-301.

18. Black CE, Costerton JW. Current concepts regarding the effect of wound microbial ecology and biofilms on wound healing. Surg Clin North Am. 2010;90(6):1147-60. doi: 10.1016/j.suc.2010.08.009.