Collagenase Ointment Research Articles

Healing Diabetic Foot Ulcers: A Comparative Review of Debridement Approaches

Introduction and objective: More than 400 million people worldwide suffer from diabetes today. As a result of complications of this disease, diabetic foot ulcers (DFU) develop. Wound treatment consists mainly in cleansing and stimulating tissue healing processes. Depending on the method used, this process may be shorter or longer. Review methods: In March 2023, articles found in the Medline (Pubmed) and Google Scholar databases were selected by using the following keywords: diabetic foot treatment, diabetic foot ulcers (DFU), autolytic debridement, healing DFU. Brief description of the state of knowledge: Each of the methods described in this article has its advantages and disadvantages. Surgical debridement is used in wounds with a large amount of necrotic tissue, but it can be associated with great discomfort for the patient. Clostridial collagenase ointment has been found to be effective in reducing wound area and promoting wound closure but is more expensive. The use of autolytic debridement and larval therapy is associated with a reduction in pro-inflammatory markers, while the use of moist dressings provides a suitable environment for tissue regeneration. Summary: The choice of the appropriate method depends on many factors such as: the patient's condition, the availability of materials and financial resources. This review paper provides a comprehensive overview of the benefits and drawbacks of different debridement methods for diabetic foot ulcers.

Comparing collagenase and silver sulfadiazine in deep second-degree burn treatment.

The indications for collagenase ointment (CO) and its efficacy are not clearly established in the treatment of second-degree burn wounds. To evaluate the efficacy of CO versus silver sulfadiazine ointment (SSD) in the treatment of second-degree burn wounds. A total of 170 eligible patients with deep second-degree burns, aged 18-65 years, with injuries occurring within 48-96h, and having a total wound area of less than 30% of the total body surface area were included from 5 centers in China. The primary outcome was the wound healing time, and the secondary outcomes were the clearance time of wound necrotic tissues, wound healing rate, and wound inflammation. The study included 85 patients in SSD group and 84 in CO group in the modified intention-to-treat (mITT) population. The median time of wound healing was comparable in both groups (10 days vs. 10.5 days P = 0.16). The time for wound necrotic tissue removal was significantly shortened by CO compared with SSD (5 vs. 10 days P < 0.01). Wound inflammation, pain, wound healing rate, and scar were compared with SSD (all P-values > 0.05). No adverse events, such as infection or allergic reactions to the drugs and materials used, were reported. Both CO and SSD could heal the burn wounds at 10 days of treatment. However, CO significantly shortened the time of wound necrotic tissue removal by 5 days. Trial Registration: ChiCTR2100046971.

Hyaluronic Acid/Collagenase Ointment in the Treatment of Chronic Hard-to-Heal Wounds: An Observational and Retrospective Study.

Background: Wound bed preparation is an important concept in clinical practice and is related to adequate debridement. The use of proteolytic enzymes is an established method of enzymatic wound debridement, especially in hard-to-heal ulcers that are unresponsive to normal healing procedures and progress. The TIME framework (tissue, inflammation/infection, moisture balance, and edge of wound) offers an appropriate strategy to eliminate resistance to healing, as well as maximizing the healing process. Maintenance debridement, as opposed to sporadic debridement, may be proposed in preserving an adequate wound bed towards complete recovery. Collagenase has been effective in debridement due to its ability to degrade collagen and elastin. In this clinical context, collagenase taken from Vibrio alginolitycus is the most favorably expressed enzymatic debriding agent. Methods: This retrospective observational study evaluates the efficacy of an ointment based on hyaluronic acid and collagenase (Bionect Start®), considering a reduced healing time and greater healing quality. We included 70 patients with chronic wounds of different etiologies, including diabetes mellitus (20), post-traumatic ulcers (35), chronic burns of degrees I and II (10), and pressure ulcers (5). We analyzed wound characteristics using the wound bed score (WBS) concept, healing time, as well as operator and patient satisfaction. Results: Frequency of debridement efficacy in terms of wound bed cleansing varied from 26% after 2 weeks to 93% after 4 weeks. We observed complete healing in 62 patients within an eight-week period. The overall operator and patient satisfaction after 8 weeks were 100% and 90%, respectively. Moreover, all patients reported less pain. Conclusions: A combined action of hyaluronic acid and collagenase ointment demonstrated a reduction in healing time while improving healing quality, with a decrease in pain.

Autologous Platelet Rich Plasma Promotes the Healing of Non-Ischemic Diabetic Foot Ulcers. A Randomized Controlled Trial

DFU (diabetic foot ulcer) represents a major global health and socioeconomic problem and a leading cause of lower limb amputation. Although many therapies have been tested, none has been proposed as a dominant wound healing treatment. We performed a prospective randomized controlled study in order to assess the role of autologous platelet rich plasma (PRP) for the promotion of non-ischemic DFU healing. After full vascular assessment, a total of 80 patients were randomized in 1:1 ratio to receive either PRP injection in the healing edge and the floor of the targeted DFU (Group A), or have usual standard care with moist dressing with or without collagenase ointment (Group B). We calculated the total surface area (TSA) for the ulcer in both groups (cm2) before, after treatment and every week up to 12 weeks of follow-up. A total of 4 patients (10%) experienced major amputation in group B, while no major amputation was performed in patients of Group A (P< 0.001). A ≥ 50% reduction in TSA occurred earlier in Group A (at 2.5 weeks), compared to Group B (4.5 weeks); P < 0.001. Complete wound healing rate was 95% (n=38) and it was achieved earlier (6th week) for patients of group A, contrary to 77.8% (n=28) of patients (9th week) for Group B (P < 0.001). Superficial wound infection was noted in 10% (n=4) of the cases in the PRP arm, while in group B, 45% (n=18) of cases had a variable degree of infection ranging from superficial to deep wound infection and cellulites (P < 0.001). PRP treatment was cost-effective, with 247.50$ vs. 437.50$ for the total cost of treatment for patients of Group B. PRP is a cost-beneficial novel modality of treatment that can accelerate wound healing and decrease the rate of local infection in DFU, compared to other conventional treatment modalities.

Role of Platelet Rich Plasma in Accelerating the Healing Rate of Diabetic Foot Ulcer

Abstract Background Diabetes is a major health problem that is currently showing an alarming rise in its prevalence, this has recently been estimated at 7.8% in the United States, presenting a &amp;gt; 50% increase over the past 15 years while there exists a large population group in whom diabetes is undiagnosed. Objective To evaluate the effectiveness and rate of healing of autologous PRP gel in treatment of diabetic foot ulcers. Compare the effectiveness of PRP gel with standard treatment (normal saline dressings). Methods 30 patients with non-ischemic DFU were classified into two groups: Group A: Patients with non-ischemic DFU and were treated with a novel modality i.e.: PRP injection in the healing edge and the floor of the targeted ulcer. GroupGroup B B:: Patients with non-ischemic DFU who had usual standard care i.e.: moist dressing with or without collagenase ointment. All cases had a minimal debridement prior to treatment, here in our study the demographic data i.e. Age, sex, medical history were homogenously distributed among both groups. All cases in both groups were non ischemic after successful revascularization either by OR or ER. Results The rate of complete healing for ulcers in group A was achieved in six patients (40%) at the fifth week, while five patients (33.33%) were healed completely by the sixth week and only one patient (6.67%) healed in the ninth week. 26.67% (n = 4 cases) in group B showed complete healing rate by eighth week and 40% (n = 6 cases) were healed by ninth week while 33.33% (n = 5 cases) were healed in the tenth week. P value was statistically significant &amp;lt;0.001 between the groups. Conclusion Activated platelet rich plasma is a novel modality in treatment of diabetic foot ulcers which is feasible, safe and effective with high rate of limb salvage rate and clinical improvement.

The role of collagenase ointment in acute burns: a systematic review and meta-analysis.

A systematic review and meta-analysis was performed to summarise the state of the literature in regard to the efficacy and uses of clostridial collagenase ointment (CCO) in the burn patient. A systematic review of articles available on PubMed, Scopus and OvidSP Medline was performed. Keywords used in the search process included burns, thermal injury, collagenase, enzymatic debridement, wound care. Reviews, case reports, independent abstracts, consensus and opinion papers were excluded. A meta-analysis was performed for articles fitting inclusion criteria. Following screening, six relevant articles were identified for systematic review. Few studies, with limited sample sizes, argue that CCO may be an effective debriding agent. It may also accelerate wound healing and avoid the pain associated with mechanical debridement. CCO lacks antimicrobial activity but the risk of burn wound infection does not appear to be significantly different than when using silver-impregnated products. CCO is more expensive than traditional wound care products but may help halt burn depth conversion and prevent the need for surgery. CCO may be a safe and effective debridement agent for burn wounds with respect to decreasing wound healing time and minimising pain without increasing the risk of infection. It should be used on a case-by-case basis due to its financial cost, which may be offset by its ability to manage burns non-operatively.

Clinical Outcomes for Diabetic Foot Ulcers Treated with Clostridial Collagenase Ointment or with a Product Containing Silver.

Objective: To compare outcomes of diabetic foot ulcers (DFUs) treated with clostridial collagenase ointment (CCO) or silver-containing products, both in combination with sharp debridement as needed.Approach: One hundred two subjects with qualifying DFUs were randomized to daily treatment with either CCO or a silver-containing product for 6 weeks followed by a 4 -week follow-up period. The primary outcome was the mean percent reduction in DFU area. A secondary outcome was the incidence of ulcer infections between groups.Results: At the end of treatment, the mean percent reduction in area from baseline of DFUs treated with CCO was 62% (p < 0.0001) and with silver was 40% (p < 0.0001). The difference between groups—22%—was not statistically significant (p = 0.071). Among ulcers closed by the end of treatment, the mean time to closure was 31.1 ± 9.0 days versus 37.1 ± 7.7 days, respectively (not statistically significant). There was a numerically greater incidence of target ulcer infections in the silver group (11, 21.6%) than in the CCO group (5, 9.8%; p = 0.208). No clinically relevant safety signals were identified in either group.Innovation: CCO treatment can progress a wound toward closure. Ulcer infection prophylaxis may not be sacrificed when treating DFU with CCO in lieu of silver-containing products.Conclusion: Both CCO and silver-containing products promote significant reduction in DFU area over 6 weeks of treatment with no clinically relevant safety concerns. Mean percent reduction in lesion area was numerically (22%) but not significantly greater with CCO compared to silver, as was time to ulcer closure, with an incidence of ulcer infection at least as low as for silver-containing products.

Clostridial collagenase ointment and medicinal honey utilization for pressure ulcers in US hospitals

Aims: To describe the utilization of clostridial collagenase ointment (CCO) and medicinal honey debridement methods in real-world inpatient and outpatient hospital settings among pressure ulcer (PU) patients and compare the frequency of healthcare re-encounters between CCO- and medicinal honey-treated patients.Materials and methods: De-identified hospital discharge records for patients receiving CCO or medicinal honey methods of debridement and having an ICD-9 code for PU were extracted from the US Premier Healthcare Database. Multivariable analysis was used to compare the frequency of inpatient and outpatient revisits up to 6 months after an index encounter for CCO- vs medicinal honey-treated PUs.Results: The study identified 48,267 inpatients and 2,599 outpatients with PUs treated with CCO or medicinal honeys. Among study inpatients, n = 44,725 (93%) were treated with CCO, and n = 3,542 (7%) with medicinal honeys. CCO and medicinal honeys accounted for 1,826 (70%) and 773 (30%), respectively, of study outpatients. In adjusted models, those treated with CCO had lower odds for inpatient readmissions (OR = 0.86, 95% CI = 0.80–0.94) after inpatient index visits, and outpatient re-encounters both after inpatient (OR = 0.73, 95% CI = 0.67–0.79) and outpatient (OR = 0.78, 95% CI = 0.64–0.95) index visits in 6 months of follow-up.Limitations: The study was observational in nature, and did not adjust for reasons why patients were hospitalized initially, or why they returned to the facility. Although the study adjusted for differences in a variety of demographic, clinical, and hospital characteristics between the treatments, we are not able to rule out selection bias.Conclusion: Patients with CCO-treated PUs returned to inpatient and outpatient hospital settings less often compared with medicinal honey-treated PUs. These results from real-world administrative data help to gain a better understanding of the clinical characteristics of patients with PUs treated with these two debridement methods and the economic implications of debridement choice in the acute care setting.

Effects of Andiroba oil (Carapa guianensis) on wound healing in alloxan-diabetic rats

Purpose: To evaluate wound healing in diabetic rats by using topic Andiroba oil (Carapa guianensis).&#x0D; Methods: Six male, adult, Wistar rats were distributed into three groups: Sham group (wound treatment with distilled water); Collagenase group (treatment with collagenase ointment); and Andiroba group (wound treatment with Andiroba oil). The wound was evaluated considering the macroscopic and microscopic parameters.&#x0D; Results: The results indicated differences in the healing of incisional wounds between treatments when compared to control group. Accelerated wound healing was observed in the group treated with Andiroba oil and Collagenase in comparison to control group, especially after the 14th day. Morphometric data confirmed the structural findings.&#x0D; Conclusion: There was significant effect in topical application of Andiroba oil on wound healing in rats with induced diabetes.&#x0D; &#x0D; Keywords: Medicinal plants. Diabetes Mellitus. Wound healing. Rats.

Clostridial Collagenase for the Management of Diabetic Foot Ulcers: Results of Four Randomized Controlled Trials.

Despite major treatment advances, diabetic foot ulcers (DFUs) remain a frequent and debilitating complication of diabetes mellitus and a major cause of significant morbidity and mortality. This study evaluates and compares clinical effectiveness of clostridial collagenase ointment (CCO) with standard care (SC) in patients with DFUs, with the goal to define best clinical criteria under which to use CCO in the DFU population. This is a pooled data analysis of 4 randomized controlled trials that compared clinical effectiveness of CCO to SC. A total of 174 adult patients with 1 target DFU each who underwent treatment with CCO (n = 88) or SC (n = 86) for 4 or 6 weeks were evaluated. Assessments included wound area reduction, wound bed status, and time to closure. Statistically significant mean percentage change in wound area from baseline was numerically greater for CCO than SC at the end of study (EOS) following 6 or 8 weeks of treatment; these values were -56% and -10%, respectively, in the subgroup of plantar surface ulcers (P = .05) and wounds assessed as "low necrosis" (≤ 25% necrotic) at baseline (-64% vs. -20%). When rapidly healing ulcers were excluded from the analysis, the difference in ulcer area reduction was even greater for CCO compared with SC at EOS (-53% vs. -7%; P = .05). Active CCO therapy was associated with a nonstatistically greater reduction in wound size than any of the passive or mechanical SC modalities at end of treatment. This was statistically significant when used in conjunction with sharp debridement and for slow healing ulcers, larger sized wounds, or plantar surface wounds.

Economic analysis and budget impact of clostridial collagenase ointment compared with medicinal honey for treatment of pressure ulcers in the US.

ObjectivesPressure ulcer (PU) treatment poses significant clinical and economic challenges to health-care systems. The aim of this study was to assess the cost-effectiveness and budget impact of enzymatic debridement with clostridial collagenase ointment (CCO) compared with autolytic debridement with medicinal honey (MH) for PU treatment from a US payer/Medicare perspective in the hospital outpatient department setting.MethodsA cost-effectiveness analysis using a Markov model was developed using a 1-week cycle length across a 1-year time horizon. The three health states were inflammation/senescence, granulation/proliferation (ie, patients achieving 100% granulation), and epithelialization. Data sources included the US Wound Registry, Medicare fee schedules, and other published clinical and cost studies about PU treatment.ResultsIn the base case analysis over a 1-year time horizon, CCO was the economically dominant strategy (ie, simultaneously conferring greater benefit at less cost). Patients treated with CCO experienced 22.7 quality-adjusted life weeks (QALWs) at a cost of $6,161 over 1 year, whereas MH patients experienced 21.9 QALWs at a cost of $7,149. Patients treated with CCO achieved 11.5 granulation weeks and 6.0 epithelization weeks compared with 10.6 and 4.4 weeks for MH, respectively. The number of clinic visits was 40.1 for CCO vs 43.4 for MH, and the number of debridements was 12.3 for CCO compared with 17.6 for MH. Probabilistic sensitivity analyses determined CCO dominant in 72% of 10,000 iterations and cost-effective in 91%, assuming a benchmark willingness-to-pay threshold of $50,000/quality-adjusted life year ($962/QALW). The budget impact analysis showed that for every 1% of patients shifted from MH to CCO, a cost savings of $9,883 over 1 year for a cohort of 1,000 patients was observed by the payer.ConclusionThe results of these economic analyses suggest that CCO is a cost-effective, economically dominant alternative to MH in the treatment of patients with PUs in the hospital outpatient department setting.

Dressings and topical agents for treating pressure ulcers.

Dressings and topical agents for treating pressure ulcers.

A comparative study of collagenase ointment versus povidone-iodine dressing in non-healing ulcers

Background: The aim of the study was to evaluate effect of collagenase ointment and povidone-iodine on non-healing ulcer in the form of duration of ulcer covered with red granulation tissue and total hospital stay.Methods: The Study was conducted on 80 patients admitted in Surgery Department, SSG Hospital and Medical College Baroda, Gujarat, India during November 2006 to October 2008. All ulcers due to trauma, chronic ulcer or infected ulcer following debridement and incision and drainage were included in this study. In group A were wounds dressed in collagenase ointment and in group B were wounds dressed in povidone-iodine ointment till second surgery or complete healing. All data from both groups were collected and analyzed by chi-square test.Results: In this study, there was no difference in age distribution (p=0.62, p&gt;0.05) with similar male to female ratio in both groups and also no significant difference in distribution of wounds size in both groups (p=0.92, p&gt;0.05). Average size of wound in group A was 43 sq. cm and group B was 44 sq. cm. The significant difference was seen on floor of ulcer by healthy granulation which came on an average of within 11days in group A and within 18 days in group B (p=0.005, p&lt;0.05). There was also a significant difference in average hospital stay, which was 25 days in group A and 35 days in group B (p=0.01, p&lt;0.05).Conclusions:Collagenase ointment is clinically more efficient as a topical dressing and lowers the morbidity by reducing the hospital stay and the duration of dressing by promoting healing in non-healing wounds than povidine-iodine ointment.

Comparative Effectiveness of Clostridial Collagenase Ointment to Medicinal Honey for Treatment of Pressure Ulcers.

Objective: Compare enzymatic debridement using clostridial collagenase ointment (CCO) with autolytic debridement using medicinal honey in the hospital outpatient setting for treating pressure ulcers (PUs).Approach: Retrospective deidentified electronic health records from 2007–2013 were extracted from the U.S. Wound Registry. Propensity score matching followed by multivariable analyses was used to adjust for selection bias and assess treatment effects comparing CCO-treated versus honey-treated PUs. Key outcomes included 100% granulation and epithelialization at 1 year.Results: Five hundred seventeen CCO-treated PUs (446 patients) were matched to corresponding honey-treated PUs (341 patients). The majority of PUs were stage III (CCO 56%, honey 55%). CCO users had significantly fewer total visits (9.1 vs. 12.6; p < 0.001), fewer total selective sharp debridements (2.7 vs. 4.4; p < 0.001), and fewer PUs receiving negative pressure wound therapy (29% vs. 38%; p = 0.002) compared with honey.Innovation: CCO-treated PUs were 38% more likely to achieve 100% granulation compared to honey-treated PUs at 1 year, p = 0.018. Mean days to 100% granulation were significantly lower for CCO-treated PUs (255 vs. 282 days, p < 0.001). CCO-treated PUs were 47% (p = 0.024) more likely to epithelialize at 1 year compared to PUs treated with honey. Mean days to epithelialization were significantly lower for PUs treated with CCO at 1 year (288 vs. 308 days; p = 0.011).Conclusion: All stages of PUs treated with CCO achieved faster rates of granulation and subsequent epithelialization compared to PUs treated with medicinal honey as measured by real-world data collected in the hospital outpatient department care setting.

Healing incisional surgical wounds using Rose Hip oil in rats

Purpose: To evaluate incisional surgical wound healing in rats by using Rose Hip (Rosa rubiginosa L.) oil.&#x0D; Methods: Twenty-one days after the oophorectomy procedure, twenty-seven female, adult, Wistar rats were distributed into three groups: Control group (wound treatment with distilled water); Collagenase group (treatment with collagenase ointment); and Rose Hip group (wound treatment with Rose Hip oil). Each group was distributed according to the date of euthanasia: 7, 14 and 21 days. The wound was evaluated considering the macroscopic and microscopic parameters.&#x0D; Results: The results indicated differences in the healing of incisional wounds between treatments when compared to control group. Accelerated wound healing was observed in the group treated with Rose Hip oil in comparison to the control and collagenase, especially after the 14th day. Morphometric data confirmed the structural findings.&#x0D; Conclusion: There was significant effect in topical application of Rose Hip oil on incisional surgical wound healing.

Cost effectiveness of adding clostridial collagenase ointment to selective debridement in individuals with stage IV pressure ulcers

Objective: The purpose of this study was to determine the cost effectiveness (from a payer’s perspective) of adding clostridial collagenase ointment (CCO) to selective debridement compared with selective debridement alone (non-CCO) in the treatment of stage IV pressure ulcers among patients identified from the US Wound Registry.Methods: A 3-state Markov model was developed to determine costs and outcomes between the CCO and non-CCO groups over a 2-year time horizon. Outcome data were derived from a retrospective clinical study and included the proportion of pressure ulcers that were closed (epithelialized) over 2 years and the time to wound closure. Transition probabilities for the Markov states were estimated from the clinical study. In the Markov model, the clinical outcome is presented as ulcer-free weeks, which represents the time the wound is in the epithelialized state. Costs for each 4-week cycle were based on frequencies of clinic visits, debridement, and CCO application rates from the clinical study. The final model outputs were cumulative costs (in US dollars), clinical outcome (ulcer-free weeks), and incremental cost-effectiveness ratio (ICER) at 2 years.Results: Compared with the non-CCO group, the CCO group incurred lower costs ($11,151 vs $17,596) and greater benefits (33.9 vs 16.8 ulcer-free weeks), resulting in an economically dominant ICER of −$375 per ulcer. Thus, for each additional ulcer-free week that can be gained, there is a concurrent cost savings of $375 if CCO treatment is selected. Over a 2-year period, an additional 17.2 ulcer-free weeks can be gained with concurrent cost savings of $6,445 for each patient.Conclusions: In this Markov model based on real-world data from the US Wound Registry, the addition of CCO to selective debridement in the treatment of pressure ulcers was economically dominant over selective debridement alone, resulting in greater benefit to the patient at lower cost.

Treating pressure ulcers with clostridial collagenase ointment: Results from the US Wound Registry.

We assessed the clinical effectiveness of clostridial collagenase ointment (CCO) as an adjunct to selective debridement compared with selective debridement alone for the management of stage IV pressure ulcers (PU) in the hospital outpatient department setting. Outcome data were derived from retrospective de-identified electronic medical records from 2007 to 2013 using the US Wound Registry. A propensity score method was used to adjust for selection bias and to test for treatment effect between PU treated with CCO plus selective debridement vs. selective debridement alone. A total of 337 CCO and 336 non-CCO stage IV PU were identified. The proportion of wounds closed at any time (e.g., at 1 or 2years) was two times greater for stage IV PU treated with CCO compared with those not treated with CCO. Kaplan-Meier analysis showed that time to wound closure at 1year was significantly faster for PU treated with CCO vs. PU not treated with CCO. Among those with five or more CCO applications or selective debridement treatments, significantly more CCO-treated PU were closed at 1 or 2years than non-CCO-treated PU. CCO as an adjunct to selective debridement improved clinical outcomes and provided faster rates of closure of stage IV PU relative to selective debridement alone.

Clostridial collagenase ointment cost effective for pressure ulcers

Clostridial collagenase ointment cost effective for pressure ulcers

CE2 - Cost Effectiveness of Adding Clostridial Collagenase Ointment To Standard of Care In Individuals With Stage IV Pressure Ulcers

CE2 - Cost Effectiveness of Adding Clostridial Collagenase Ointment To Standard of Care In Individuals With Stage IV Pressure Ulcers

PSS2 - The Comparative Effectiveness Of Adding Clostridial Collagenase Ointment To Standard Of Care In Individuals With Stage Iv Pressure Ulcers

PSS2 - The Comparative Effectiveness Of Adding Clostridial Collagenase Ointment To Standard Of Care In Individuals With Stage Iv Pressure Ulcers