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.
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.
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.
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.
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.
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.
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.
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