Clostridial Collagenase and Negative Pressure Wound Therapy
Clostridial Collagenase and Negative Pressure Wound Therapy
In this study, 114 medical charts each pertaining to 1 patient wound were identified for further analysis. Two groups were established comparing patients who were treated with NPWT alone compared to patients who were treated with NPWT + CCO. Table 2 demonstrates homogeneity between the 2 groups with respect to age, body mass index, albumin, hemoglobin, hematocrit, glucose, blood urea nitrogen, creatinine, and initial wound surface area with no significant differences for the parameters observed. Data suggests these patients were medically compromised with respect to their general condition. On average, many of the patients studied were elderly, overweight, anemic, and had endocrine/renal compromise noted on their baseline laboratory tests (Table 2). Labs also indicated that many of the subjects were in a state of protein calorie malnutrition with albumin values substantially diminished compared to well elderly patients. The mean wound starting size was > 50 cm and many wounds were located on the posterior or lateral pelvis (Table 3).
Thorough analysis was conducted using an independent group t test with unequal variance assumption to attain P values and determine if any attributes, such as wound area reduction, LTAC length of stay, debridement effectiveness and/or BWAT change, were statistically significant. A P value ≤ 0.05 was determined to be indicative of statistical significance.
The study sample included 67 patients treated with NPWT + CCO and 47 patients who received only NPWT (Table 4). Results were similar for both treatment groups with mean values indicating the cohorts were closely aligned with respect to wound size, complexity, length of LTAC stay, and duration of NPWT treatment. The patients who received NPWT + CCO demonstrated statistically significant changes in several key areas including starting BWAT score, changes in the overall BWAT score, and the necrotic tissue domain. For clarification, the term "necrotic tissue domain of BWAT" combines items number 5 (necrotic tissue type) and 6 (necrotic tissue amount) from the BWAT scale (Table 1).
Analysis also identified statistical differences between patients who had or had not received sharp debridement during their LTAC stays (Table 5). Of the 41 patients who had received sharp debridement, 10 received NPWT alone and 31 received NPWT + CCO. Results indicated significance of the NPWT + CCO group with respect to overall BWAT change (P = 0.045) and the change in necrotic tissue domain of BWAT (P = 0.002). Additionally, a sensitivity analysis was performed to identify any differences between 2 specific subgroups. The treatment subgroup (n = 31) was defined as patients who received sharp debridement and CCO, and the control subgroup (n = 37) was defined as patients who had no sharp debridement and no CCO. Statistically significant differences (P < 0.05) were observed between treatment and control groups on overall BWAT score change (-2.34) and BWAT necrotic domain score change (-2.39) (Figure 1). The treatment subgroup was statistically more likely to have diabetes (OR = 5.20; 95% CI: 1.76–15.40) and arterial disease (OR = 12.52; 95% CI: 1.46–23.82).
(Enlarge Image)
Figure 1.
Statistical result of treatment and control group on overall Bates-Jensen Wound Assessment Tool score change.
BWAT: Bates-Jensen Wound Assessment Tool; CCO: clostridial collagenase ointment
Results
In this study, 114 medical charts each pertaining to 1 patient wound were identified for further analysis. Two groups were established comparing patients who were treated with NPWT alone compared to patients who were treated with NPWT + CCO. Table 2 demonstrates homogeneity between the 2 groups with respect to age, body mass index, albumin, hemoglobin, hematocrit, glucose, blood urea nitrogen, creatinine, and initial wound surface area with no significant differences for the parameters observed. Data suggests these patients were medically compromised with respect to their general condition. On average, many of the patients studied were elderly, overweight, anemic, and had endocrine/renal compromise noted on their baseline laboratory tests (Table 2). Labs also indicated that many of the subjects were in a state of protein calorie malnutrition with albumin values substantially diminished compared to well elderly patients. The mean wound starting size was > 50 cm and many wounds were located on the posterior or lateral pelvis (Table 3).
Thorough analysis was conducted using an independent group t test with unequal variance assumption to attain P values and determine if any attributes, such as wound area reduction, LTAC length of stay, debridement effectiveness and/or BWAT change, were statistically significant. A P value ≤ 0.05 was determined to be indicative of statistical significance.
The study sample included 67 patients treated with NPWT + CCO and 47 patients who received only NPWT (Table 4). Results were similar for both treatment groups with mean values indicating the cohorts were closely aligned with respect to wound size, complexity, length of LTAC stay, and duration of NPWT treatment. The patients who received NPWT + CCO demonstrated statistically significant changes in several key areas including starting BWAT score, changes in the overall BWAT score, and the necrotic tissue domain. For clarification, the term "necrotic tissue domain of BWAT" combines items number 5 (necrotic tissue type) and 6 (necrotic tissue amount) from the BWAT scale (Table 1).
Analysis also identified statistical differences between patients who had or had not received sharp debridement during their LTAC stays (Table 5). Of the 41 patients who had received sharp debridement, 10 received NPWT alone and 31 received NPWT + CCO. Results indicated significance of the NPWT + CCO group with respect to overall BWAT change (P = 0.045) and the change in necrotic tissue domain of BWAT (P = 0.002). Additionally, a sensitivity analysis was performed to identify any differences between 2 specific subgroups. The treatment subgroup (n = 31) was defined as patients who received sharp debridement and CCO, and the control subgroup (n = 37) was defined as patients who had no sharp debridement and no CCO. Statistically significant differences (P < 0.05) were observed between treatment and control groups on overall BWAT score change (-2.34) and BWAT necrotic domain score change (-2.39) (Figure 1). The treatment subgroup was statistically more likely to have diabetes (OR = 5.20; 95% CI: 1.76–15.40) and arterial disease (OR = 12.52; 95% CI: 1.46–23.82).
(Enlarge Image)
Figure 1.
Statistical result of treatment and control group on overall Bates-Jensen Wound Assessment Tool score change.
BWAT: Bates-Jensen Wound Assessment Tool; CCO: clostridial collagenase ointment
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