Clostridial Collagenase and Negative Pressure Wound Therapy
Nonhealing, chronic pressure ulcers present a continuous challenge in the global health care venue, with decreased mobility and the effects of aging on skin placing the elderly at particular risk. Debridement is an important process to decrease risk of infection and promote healing. Enzymatic debridement with, for example, clostridial collagenase ointment (CCO) has been shown to assist with the achievement and maintenance of a clean wound bed in preparation for closure. Negative pressure wound therapy (NPWT) has also been used successfully for the treatment of wounds. Although conclusive research has demonstrated positive independent effects of both CCO and NPWT as treatments for chronic pressure ulcers, there are no known published studies that have investigated the 2 as a conjunctive treatment. Materials and Methods. A retrospective analysis of 114 adult patients was conducted to assess wound healing of chronic pressure ulcers in a setting with medically complex patients. Two groups were established comparing those who received NPWT alone to those who received NPWT plus CCO. The study sample included 67 patients treated with NPWT + CCO and 47 patients who received only NPWT. Results. Results were similar for both treatment groups with mean values indicating the cohorts were closely aligned with respect to wound size, complexity, length of long-term acute care hospital stay, and duration of NPWT. The patients who received NPWT + CCO demonstrated statistically significant changes in several key areas including initial Bates-Jensen Wound Assessment Tool (BWAT) score, changes in the overall BWAT score and in the necrotic tissue domain. Conclusion. Data analysis from this retrospective study indicates patients who received both therapies (NPWT + CCO) demonstrated improved outcomes in speed of debridement and rate of wound closure compared to those who received NPWT alone.
Nonhealing, chronic pressure ulcers present dramatic clinical and economic challenges for health care providers. Pressure ulcers are most frequently seen in the sacral, ischial, trochanteric, and calcaneal regions and are commonly caused by unrelieved pressure on soft tissue over bony prominences resulting in ischemia and necrosis. Further, immobility, decreased sensation, and advanced age all increase an individual's risk of developing pressure-related wounds. Additional risk factors include compromised nutritional status and excessive exposure to friction, shear forces, and moisture. Economically, the cost of chronic wound treatment has escalated due to prolonged hospital stays and extensive medical interventions, among other factors.
Debridement of pressure ulcers is recognized as an important process to remove impediments to wound healing, decrease risk of infection, and promote proliferation of granulation tissue. Sharp debridement is a method of debridement in which necrotic tissue is excised from the wound bed using instruments such as scalpels and curettes. Enzymatic debridement is another beneficial approach for wound bed preparation in which topically applied enzymes are used to digest and dissolve devitalized tissue in the wound. Bacterial collagenase isolated from Clostridium histolyticum is a selective enzymatic agent that has been found to cause hydrolytic cleavage of collagen molecules, which are a major component of nonviable tissue in the wound bed. Clostridial collagenase ointment (CCO) has been used in conjunction with other forms of debridement, such as surgical/sharp, for initial and continuous debridement. Studies have indicated that CCO provides effective debridement in a variety of wound types including pressure ulcers, venous/arterial ulcers, diabetic foot ulcers, and burns. Clostridial collaganese ointment can also provide ongoing debridement of necrotic tissue throughout the wound healing continuum through an action described in the literature as "maintenance debridement." Falanga first defined maintenance debridement as the process by which CCO continuously inhibits reaccumulation of necrotic tissue and restores the healing mode by a process of continuously debriding the wound bed. Clostridial collaganese ointment is currently the only enzymatic debriding ointment that has US Food and Drug Administration approval (Collagenase Santyl Ointment, Smith and Nephew, Hull, UK).
Negative pressure wound therapy (NPWT) is another treatment used extensively to expedite the healing of wounds of multiple etiologies including pressure ulcers. Negative pressure wound therapy has been clinically demonstrated to accelerate the healing process of acute, subacute, and chronic wounds through the application of subatmospheric negative pressure. Promotion of a moist wound environment, removal of cytotoxic metalloproteases, edema reduction, and cell proliferation are among the proposed mechanisms of action for NPWT. Negative pressure wound therapy is available worldwide in commercial applications from several different companies.
Pharmacoeconomic data indicates CCO may reduce overall wound care costs by accelerating the healing process and lowering resource utilization. Likewise, data indicates that NPWT may have a similar cost benefit advantage over standard care. The purpose of this study was to evaluate the effectiveness of wound closure using CCO in conjunction with NPWT vs NPWT alone for the treatment of chronic pressure ulcers. Previous research has demonstrated the efficacy of enzymatic debridement or subatmospheric negative pressure for healing of chronic pressure ulcers; however, no known studies have evaluated the conjunctive effects of CCO and NPWT. The primary author's clinical observation and experience with the conjunctive use of the 2 therapies indicated a potential clinical benefit that merited further study. The research question posed was whether the addition of CCO to the wound would improve certain healing characteristics for patients with chronic pressure ulcers who were also receiving NPWT. Specifically, would the addition of CCO affect the rate of wound debridement and wound closure.
Abstract and Introduction
Abstract
Nonhealing, chronic pressure ulcers present a continuous challenge in the global health care venue, with decreased mobility and the effects of aging on skin placing the elderly at particular risk. Debridement is an important process to decrease risk of infection and promote healing. Enzymatic debridement with, for example, clostridial collagenase ointment (CCO) has been shown to assist with the achievement and maintenance of a clean wound bed in preparation for closure. Negative pressure wound therapy (NPWT) has also been used successfully for the treatment of wounds. Although conclusive research has demonstrated positive independent effects of both CCO and NPWT as treatments for chronic pressure ulcers, there are no known published studies that have investigated the 2 as a conjunctive treatment. Materials and Methods. A retrospective analysis of 114 adult patients was conducted to assess wound healing of chronic pressure ulcers in a setting with medically complex patients. Two groups were established comparing those who received NPWT alone to those who received NPWT plus CCO. The study sample included 67 patients treated with NPWT + CCO and 47 patients who received only NPWT. Results. Results were similar for both treatment groups with mean values indicating the cohorts were closely aligned with respect to wound size, complexity, length of long-term acute care hospital stay, and duration of NPWT. The patients who received NPWT + CCO demonstrated statistically significant changes in several key areas including initial Bates-Jensen Wound Assessment Tool (BWAT) score, changes in the overall BWAT score and in the necrotic tissue domain. Conclusion. Data analysis from this retrospective study indicates patients who received both therapies (NPWT + CCO) demonstrated improved outcomes in speed of debridement and rate of wound closure compared to those who received NPWT alone.
Introduction
Nonhealing, chronic pressure ulcers present dramatic clinical and economic challenges for health care providers. Pressure ulcers are most frequently seen in the sacral, ischial, trochanteric, and calcaneal regions and are commonly caused by unrelieved pressure on soft tissue over bony prominences resulting in ischemia and necrosis. Further, immobility, decreased sensation, and advanced age all increase an individual's risk of developing pressure-related wounds. Additional risk factors include compromised nutritional status and excessive exposure to friction, shear forces, and moisture. Economically, the cost of chronic wound treatment has escalated due to prolonged hospital stays and extensive medical interventions, among other factors.
Debridement of pressure ulcers is recognized as an important process to remove impediments to wound healing, decrease risk of infection, and promote proliferation of granulation tissue. Sharp debridement is a method of debridement in which necrotic tissue is excised from the wound bed using instruments such as scalpels and curettes. Enzymatic debridement is another beneficial approach for wound bed preparation in which topically applied enzymes are used to digest and dissolve devitalized tissue in the wound. Bacterial collagenase isolated from Clostridium histolyticum is a selective enzymatic agent that has been found to cause hydrolytic cleavage of collagen molecules, which are a major component of nonviable tissue in the wound bed. Clostridial collagenase ointment (CCO) has been used in conjunction with other forms of debridement, such as surgical/sharp, for initial and continuous debridement. Studies have indicated that CCO provides effective debridement in a variety of wound types including pressure ulcers, venous/arterial ulcers, diabetic foot ulcers, and burns. Clostridial collaganese ointment can also provide ongoing debridement of necrotic tissue throughout the wound healing continuum through an action described in the literature as "maintenance debridement." Falanga first defined maintenance debridement as the process by which CCO continuously inhibits reaccumulation of necrotic tissue and restores the healing mode by a process of continuously debriding the wound bed. Clostridial collaganese ointment is currently the only enzymatic debriding ointment that has US Food and Drug Administration approval (Collagenase Santyl Ointment, Smith and Nephew, Hull, UK).
Negative pressure wound therapy (NPWT) is another treatment used extensively to expedite the healing of wounds of multiple etiologies including pressure ulcers. Negative pressure wound therapy has been clinically demonstrated to accelerate the healing process of acute, subacute, and chronic wounds through the application of subatmospheric negative pressure. Promotion of a moist wound environment, removal of cytotoxic metalloproteases, edema reduction, and cell proliferation are among the proposed mechanisms of action for NPWT. Negative pressure wound therapy is available worldwide in commercial applications from several different companies.
Pharmacoeconomic data indicates CCO may reduce overall wound care costs by accelerating the healing process and lowering resource utilization. Likewise, data indicates that NPWT may have a similar cost benefit advantage over standard care. The purpose of this study was to evaluate the effectiveness of wound closure using CCO in conjunction with NPWT vs NPWT alone for the treatment of chronic pressure ulcers. Previous research has demonstrated the efficacy of enzymatic debridement or subatmospheric negative pressure for healing of chronic pressure ulcers; however, no known studies have evaluated the conjunctive effects of CCO and NPWT. The primary author's clinical observation and experience with the conjunctive use of the 2 therapies indicated a potential clinical benefit that merited further study. The research question posed was whether the addition of CCO to the wound would improve certain healing characteristics for patients with chronic pressure ulcers who were also receiving NPWT. Specifically, would the addition of CCO affect the rate of wound debridement and wound closure.
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