December - January 2023
Dr Aliza Lee Clinical Research Investigator, Department of Veterans Affairs Salem VA, United StatesThe Safe Guide to Debridement in the Challenging Clinical Setting
Editorial Summary
Debridement should be carried out as part of standard of care treatment. Safety and minimising of complications are essential when carrying out debridement in various clinical settings. Standard of care for debridement involves initial debridement to healthy tissue and any further weekly debridements as required. Debridement methods can be generalized into five broad categories, autolytic, enzymatic, biologic, mechanical, and sharp debridement.1-4 This article explores how wound debridement in anticoagulated patients can be achieved safely with use of a chitosan-based hemostatic agent.
Introduction
Several wound care guidelines strongly recommend debridement be performed as part of the standard of care in the treatment of wounds.1-6 This recommendation has been in place through several iterations of wound care guidelines as wound debridement has been shown to reduce time to complete healing and increase the number of healed wounds.1,7 The recommended standard of care for debridement involves initial debridement followed by routine debridement to maintain a healthy wound base to promote wound resolution..2,3,8 Debridement methods can be generalized into five broad categories, autolytic, enzymatic, biologic, mechanical, and sharp debridement.1-4 While limited evidence exists to support the use of one debridement modality over another, ease of access, cost effectiveness, time efficiency in removal of nonviable and infected tissue, the ability to remove large amounts of tissue quickly and significantly reduce the number of microorganisms in the wound bed, make sharp debridement the preferred technique.1,3,7 Despite these recommendations, the use of sharp debridement may be limited due to patient factors, such as pain and insufficient arterial supply, and provider factors, such as limited experience, skill, scope of practice and licensing restrictions, resource access, and the concern that sharp debridement may cause the patient harm.1,3,4,6,8 One of these latter concerns that providers may have with sharp debridement is its relative contraindication in patients with bleeding disorders or those on anticoagulant therapy.3 Multiple modalities exist for achieving hemostasis following
wound debridement. The most common modalities utilized in the outpatient, inpatient, and operating room setting include holding pressure, use of various topical hemostatic agents, chemical cautery with silver nitrate, and electrocautery.9,10 Disadvantages of these methods of achieving hemostasis include the time required to achieve hemostasis, the potential for tissue injury, expense, lack of access to necessary supplies, and the time required by the provider for appropriate follow up.3,11 Providers may choose to perform limited wound debridement or avoid it altogether in this patient population for these reasons, potentially contributing to delayed wound healing.8
Chitosan is a naturally occurring biocompatible, biodegradable, and non-toxic hemostatic agent with antimicrobial and antifungal properties that has been shown to promote wound healing.12 Presented here are the results of use of a chitosanbased hemostatic agent (OMNI-STAT®, Omnistat Medical Inc, New York, NY) following wound debridement in anticoagulated patients.
Methods
A review of a series of patients on anticoagulant therapy with wounds requiring debridement, in the outpatient and operating room settings, in which a chitosan-based hemostatic agent was used to achieve hemostasis was performed. Sharp debridement was performed in all patients. After sharp debridement to bleeding tissue, chitosan-based granules and/ or impregnated gauze were applied to the wound following the protocol outlined in Table 1. The incidence of rebleed following sharp debridement was collected.
Results
Twelve patients on anticoagulant therapy underwent sharp debridement of their wound. All the patients were male. The average patient age was 69.9 ± 7.4 years. Patients were on an average of 2 anticoagulant medications (range: 1 – 3), including Apixaban, Aspirin, Clopidogrel, Heparin, Lovenox, and Warfarin. (Table 2) Wound etiologies included acute and chronic wounds due to pressure, diabetes, peripheral arterial disease, mixed arterial disease and venous insufficiency, and trauma. Sharp and/ or hydrosurgical debridement was performed in all patients in either the outpatient or operative setting. The level of debridement ranged from subcutaneous tissue to bone. Eight patients had coagulation labs drawn, two (25.0%) of these patients had elevated or near critical INR levels. Only one patient had occurrence of a rebleed following intraoperative surgical debridement. Rebleed did not occur in the two patients with elevated or near critical INR levels who underwent surgical debridement.
Discussion
Debridement is a central component in the standard of care for treatment of acute and chronic wounds. A 28-day reduction in time to healing for diabetic foot ulcerations has been reported when debridement is included in the treatment protocol compared to when debridement is not a part of the treatment protocol.7 Given the accelerated time to healing and incidence of healed wounds, multiple guidelines provide a strong recommendation that the standard of care for wounds include initial and routine sharp debridement.1-7 Sharp debridement is recommended to such an extent that while one guideline states that sharp debridement is a relative contraindication in patients with bleeding disorders or an anticoagulant therapy, as it must be performed “to bleeding tissue”, the same guideline also recommends the use of clean, dry dressings
for the first 8-24 hours for wounds associated with bleeding with subsequent use of moist dressings once hemostasis is obtained.3,6,9
Despite the existence of multiple modalities to achieve hemostasis, no “gold standard” exists.11 Currently available hemostatic modalities used in the outpatient, inpatient, and operating room settings are limited by provider preference, the time required to achieve hemostasis, resource availability, cost, and the potential for causing the patient harm.1,3,4,6,8 In a survey of 75 Australian podiatrists and wound care nurses, lack of staff time and resource access and requirements were cited as one of the top three reasons for less frequent wound debridement.8 The time required for holding pressure for bleeding cessation in patients on anticoagulant therapy can be longer than the normal bleeding time of <3 minutes to <8 minutes.13 Less frequent wound debridement was also noted by providers practicing in rural areas compared to those practicing in urban areas.8 While the reason for this difference was not stated, one can speculate that providers in urban areas have greater access to the time and resources required should a complication with debridement occur. Topical hemostatic agents, such as flowables, gelatins, thrombins, and oxidized regenerated celluloses, are most often used in the operating room setting. Costs of these hemostatic agents range from $50 to >$500.14 While some may argue that the cost of the product itself is inconsequential, the total cost related to operating room time, staff, equipment and necessary supplies, and a potential need for return to the operating room must be considered. A study comparing use of a chitosan-based hemostatic agent to electrocautery following sharp debridement in the operating room setting found use of the chitosan-based hemostatic agent resulted in less time to achieve hemostasis and reduced preprocedure and procedure times.15 The study included 112 patients, 59 of which were treated with the chitosan-based hemostatic agent and
“Despite the existence of multiple modalities to achieve hemostasis, no “gold standard” exists.”
89 of which were treated with electrocautery following sharp debridement. Patients on anticoagulant therapy comprised 60.7% of patients treated with electrocautery and 42.3% of patients treated with the chitosan-based hemostatic agent. The time required to achieve hemostasis following sharp debridement was ~10 minutes less with the chitosan-based hemostatic agent than with electrocautery (38:58 vs 48:11, p<0.001), a significant reduction in time. A significant reduction in pre-procedure (20:37 vs 24:53, p<0.001) and procedure times (10:10 vs 14:37, p<0.001), ~4 minutes less for patients treated with the chitosanbased hemostatic agent compared to those treated with electrocautery, was also reported. These significant differences in times may be related to the need for several large pieces of equipment for electrocautery and the time for individualized cautery of each bleeding vessel. Use of the chitosan-based hemostatic agent does not require any additional equipment and provides rapid hemostasis of the entire wound at one time. The reduction in perioperative and operative times with use of the chitosanbased hemostatic agent compared to the use of electrocautery has the potential to reduce healthcare resource utilization as one minute of operating room time, excluding the costs associated with anesthesia, implants, radiology, pathology, and physician services, has been estimated to be $46.04.16 Electrocautery, as well as the use of silver nitrate for chemical cautery, also cause tissue damage that the patient’s body must heal in addition to the initial tissue breakdown related to the wound.9 The disadvantages associated with current methods of achieving hemostasis following wound debridement may result in limited or no wound debridement being performed. Suboptimal wound debridement, or the lack of wound debridement altogether, can increase the patient’s risk for delayed wound healing and its associated complications.
An unmet need exists for a cost-effective, rapid, effective, non-caustic hemostatic agent that can be utilized in the surgical, inpatient, and outpatient settings. Use of a chitosan-based hemostatic agent and/or chitosan impregnated gauze may fill this unmet need. In addition to the potential cost savings mentioned above, this agent could increase provider confidence to provide the standard of care for wound treatment for patients with bleeding disorders or those on anticoagulant therapies, which
includes optimal sharp debridement to bleeding tissue to accelerate wound healing. A study that evaluated the use of a chitosanbased gelling fiber dressing (Opticell, Medline Industries, Inc., Northfield, IL) following wound debridement in the outpatient setting reported reduced times to achieving hemostasis and reduction in wound size at one week.12 The study included 20 patients with chronic wounds of various etiologies. Seventeen (85%) patients had sharp debridement performed, the remaining three (15%) patients had electrocautery alone or sharp debridement followed by electrocautery. Bleeding following debridement was described as moderate to severe in 11 (55%) patients. Hemostasis was achieved in all patients at ~1-minute. Of the 18 patients evaluated 1-week following initial treatment, 9 (50%) had a significant reduction in wound size.
The cases presented here further support the ability of a chitosan-based hemostatic agent to achieve rapid hemostasis in acute and chronic wounds in patients on anticoagulant therapy. In addition to achieving rapid hemostasis, use of the chitosan-based hemostatic agent in this case series suggests that its use may also support healing in a variety of ways. First, the ability to achieve rapid hemostasis allowed for the early use of other advanced wound care products to aid in accelerated wound healing. Second, the biocompatible, innate, and nontoxic properties of chitosan avoid the additional tissue damage associated with the use of chemical cautery or electrocautery, negating further stress on the patient’s natural reparative mechanisms.17 Third, the inherent properties of chitosan may also aid in wound healing. Chitosan has been demonstrated to provide a 3-dimensional extracellular matrix, and stimulate macrophages, fibroblast proliferation, and keratinocyte delivery, key components of the proliferative phase of wound healing.12,17,18 Chitosan may also increase collagen deposition and organization, potentially increasing the tensile strength of wounds once they are healed.18 One patient in this case series achieved wound resolution following the discontinuation of all advanced wound care products and treatment with debridement and application of the chitosanbased hemostatic agent alone. Chitosan has also been shown to have inherent bacteriostatic and bactericidal effects which may assist in infection prevention.17,18
Results of the case series presented here support the use of the chitosan-based hemostatic agent following guideline recommended sharp debridement to bleeding tissue in patients on anticoagulant therapy given its ability to achieve rapid hemostasis. In addition to the ability to achieve rapid hemostasis in this patient population, use of the chitosan-based hemostatic agent may help expedite wound resolution due to its ability to promote early advanced wound care product use and the potentially beneficial inherent properties of chitosan.
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