The combination of hyaluronic acid and collagenase in the treatment of skin ulcers: an open, multicenter clinical study assessing safety and tolerability of Bionect Start®.

OBJECTIVE: Several clinical studies have shown that hyaluronic acid collagenase is well-tolerated and very effective in managing chronic venous ulcers. The aim of the present study is to confirm the safety and tolerability of daily application in patients suffering from cutaneous ulcers of different etiologies. The efficacy of the treatment and its impact on patients' quality of life are also assessed. PATIENTS AND METHODS: Patients with a clinical diagnosis of skin ulcer with devitalized/fibrinous/slough tissue that could delay the healing process were enrolled in the study. The hyaluronic acid/collagenase ointment was applied topically until wound closure or total debridement of non-viable tissue was achieved, however, with a limit of 30 days. Monitoring was performed weekly, either through outpatient visits or telephone surveys. Assessments included adverse events, local irritation reactions, pain at dressing changes, and wound bed status. Patients were also requested to complete a quality-of-life questionnaire. RESULTS: The study involved 96 patients with a mean age of 71 years. The patients suffered mainly from traumatic (21.9%), venous (15.6%), or pressure ulcers (12.5%); in 26% of cases, ulcers had mixed etiology. In approximately 32% of patients, the ulcer had been present for more than 6 months, and 18.1% of subjects had previously undergone surgical wound debridement. CONCLUSIONS: Daily application of hyaluronic acid-collagenase achieved the following results: i) absence of adverse events related to the use of the product; ii) significant reduction in the degree of localized irritation and pain at dressing changes; iii) significant support to wound bed preparation; iv) trend towards improvement in the quality of life and health status of the patients.

Surgery, Needle Fasciotomy, or Collagenase Injection for Dupuytren Contracture : A Randomized Controlled Trial.

BACKGROUND: Surgery, needle fasciotomy, and collagenase injection are used to treat Dupuytren contracture. The treatment decision requires balancing initial morbidity and costs of surgery against its potential long-term benefits over needle fasciotomy and collagenase. OBJECTIVE: To compare the effectiveness of surgery, needle fasciotomy, and collagenase injection at 3 months and 2 years (secondary time points of the trial). DESIGN: A multicenter, randomized, outcome assessor-blinded, superiority trial. (ClinicalTrials.gov: NCT03192020). SETTING: 6 public hospitals in Finland. PARTICIPANTS: 302 persons with treatment-naive Dupuytren contracture (contracture angle <135°). INTERVENTION: Surgery (n = 101), needle fasciotomy (n = 101), or collagenase (n = 100). MEASUREMENTS: The primary outcome was the success rate, defined as greater than 50% contracture release and patients reaching the patient acceptable symptom state. Secondary outcomes included hand function, pain, quality of life, patient satisfaction, residual contracture angle, finger flexion, risk for retreatment, and serious adverse events. RESULTS: A total of 292 (97%) and 284 (94%) participants completed the 3-month and 2-year follow-ups. Success rates were similar at 3 months: 71% (95% CI, 62% to 80%) for surgery, 73% (CI, 64% to 82%) for needle fasciotomy, and 73% (CI, 64% to 82%) for collagenase. At 2 years, surgery had superior success rates compared with both needle fasciotomy (78% vs. 50%; adjusted risk difference [aRD], 0.30 [CI, 0.17 to 0.43]) and collagenase (78% vs. 65%; aRD, 0.13 [CI, 0.01 to 0.26]). Secondary analyses paralleled with the primary analysis. LIMITATION: Participants were not blinded. CONCLUSION: Initial outcomes are similar between the treatments, but at 2 years success rates were maintained in the surgery group but were lower with both needle fasciotomy and collagenase despite retreatments. PRIMARY FUNDING SOURCE: Research Council of Finland.

Anti-inflammatory effects of sericin and swimming exercise in treating experimental Achilles tendinopathy in rat.

The aim of this study was to assess the effectiveness of combining sericin with swimming exercise as a treatment for type-I collagenase-induced Achilles tendinopathy (AT) in rats, with a focus on inflammatory cytokines. An experimental AT model was established using type-I collagenase in male Sprague-Dawley rats, categorized into five groups: Group 1 (Control + Saline), Group 2 (AT), Group 3 (AT + exercise), Group 4 (AT + sericin), and Group 5 (AT + sericin + exercise). Intratendinous sericin administration (0.8 g/kg/mL) took place from days 3 to 6, coupled with 30 min daily swimming exercise sessions (5 days/week, 4 weeks). Serum samples were analyzed using ELISA for tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1ß), interleukin-10 (IL-10), and total antioxidant-oxidant status (TAS-TOS), alongside histopathological and immunohistochemical assessments of Achilles tendon samples. Elevated TNF-α and IL-1ß and decreased IL-10 levels were evident in Group 2; Of these, TNF-α and IL-1ß were effectively reduced and IL-10 increased across all treatment groups, particularly groups 4 and 5. Serum TAS was notably lower in Group 2 and significantly increased in Group 5 compared to Group 2. Histopathologically, Group 2 displayed severe degeneration, irregular fibers, and round cell nuclei, while Group 5 exhibited decreased degeneration and spindle-shaped fibers. The Bonar score increased in Group 2 and decreased in groups 4 and 5. Collagen type-I alpha-1 (Col1A1) expression was notably lower in Group 2 (P = 0.001) and significantly increased in groups 4 and 5 compared to Group 2 (P = 0.011 and 0.028, respectively). This study underscores the potential of sericin and swimming exercises in mitigating inflammation and oxidative stress linked to AT pathogenesis, presenting a promising combined therapeutic strategy.

Dermoabrasión como alternativa de tratamiento en quemaduras tipo AB en pacientes pediátricos. Experiencia del Servicio de Cirugía Plástica, Unidad de Quemados del Hospital Pediátrico Fernando Bareyro / Dermoabrasion for treatment in pediatric burns

La dermoabrasión en combinación con sulfadiazina de plata y lidocaína, como tratamiento para las quemaduras AB en pacientes pediátricos, presenta ventajas en cuanto a los resultados que ofrece, ya que es un método sencillo y reproducible. Como desventaja presenta que se requieren varias sesiones de tratamiento y en algunos casos, donde se produjo profundización de la lesión, se requirió cobertura con injerto de pie

Hematological change parameters in patients with pressure ulcer at long-term care hospital / Alterações dos parâmetros hematológicos em pacientes portadores de úlcera por pressão em um hospital de longa permanência

Objective To assess factors associated with the development of pressure ulcers, and to compare the effectiveness of pharmacological treatments. Methods The factors associated with the development of pressure ulcers were compared in lesion-carrying patients (n=14) and non-carriers (n=16). Lesion-carrying patients were treated with 1% silver sulfadiazine or 0.6IU/g collagenase and were observed for 8 weeks. The data collected was analyzed with p<0.05 being statistically relevant. Results The prevalence of pressure ulcers was about 6%. The comparison of carrier and non-carrier groups of pressure ulcers revealed no statistically significant difference in its occurrence with respect to age, sex, skin color, mobility, or the use of diapers. However, levels of hemoglobin, hematocrit, and red blood cells were found to be statistically different between groups, being lower in lesion-carrying patients. There was no significant difference found in lesion area between patients treated with collagenase or silver sulfadiazine, although both groups showed an overall reduction in lesion area through the treatment course. Conclusion Hematologic parameters showed a statistically significant difference between the two groups. Regarding the treatment of ulcers, there was no difference in the area of the lesion found between the groups treated with collagenase and silver sulfadiazine. .

Objetivo Avaliar os fatores associados ao desenvolvimento da úlcera por pressão e comparar a efetividade de tratamentos farmacológicos. Métodos Os fatores associados ao desenvolvimento de úlcera por pressão foram comparados entre pacientes portadores (n=14) e não portadores (n=16) da lesão. Os pacientes com a ferida foram tratados com sulfadiazina de prata 1% ou colagenase 0,6UI/g, sendo acompanhados durante 8 semanas. Os dados coletados foram analisados considerando-se estatisticamente significativo se p<0,05. Resultados A prevalência de úlcera por pressão foi de cerca de 6%. A comparação entre os grupos de portadores e não portadores de úlcera por pressão não revelou diferença estatística significativa entre ocorrência desta segundo idade, sexo, cor da pele, mobilidade e uso de fralda. Por outro lado, os valores de hemoglobina, hematócrito e hemácias foram estatisticamente diferentes entre os grupos, sendo menor naqueles pacientes portadores da lesão. Não houve diferença significativa na área da lesão entre aqueles pacientes tratados com colagenase ou sulfadiazina de prata, embora ambos os tratamentos tenham evidenciado uma redução média da área da lesão. Conclusão Os parâmetros hematológicos apresentaram diferença estatística entre os dois grupos avaliados, ao contrário das demais variáveis analisadas. Em relação ao tratamento das úlceras, não houve diferença na área da lesão na comparação entre a colagenase e a sulfadiazina. .

Amniotic membrane as a biological dressing in infected wound healing in rabbits

PURPOSE: To investigate amniotic membrane as a biological dressing in infected wound healing in rabbits. METHODS: The use of preserved amniotic membranes (AMs) was examined using 15 rabbits with experimentally induced wound infections on their backs. Healing was histologically evaluated during different phases including inflammation, granulation, epithelialization, and fibroplasia. The animals were distributed into three groups for histological study at seven, 14, 21, and 28 days post-wound induction. Group A did not receive treatment: the wound was left exposed and dry; Group B received a daily exposure treatment with collagenase; and Group C received one AM, which also remained exposed. RESULTS: A marked reduction of the inflammatory phase was observed in Group C at 21 days, and the granulation phase of this healing increased at 14 days. Epithelialization was similar among the three groups, and fibroplasia was more pronounced in Group C at 14 days. Furthermore, gradual collagen organization also began for the animals in Group B at 14 days. CONCLUSION: The amniotic membrane did not significantly alter the inflammation, epithelialization, or fibroplasia phases but did increase angiogenesis up to Day 14 compared with the dry dressing and collagenase treatments. .

Tratamento de queimadura de segundo grau superficial em face e pescoço com heparina tópica: estudo comparativo, prospectivo e randomizado / Treatment of superficial second degree burn of face and neck with topical heparin: a comparative, prospective and randomized study

INTRODUÇÃO: Novas opções terapêuticas para o tratamento de lesões térmicas são constantemente buscadas, especialmente se reduzirem tempo de cicatrização e dor, sem aumentar as taxas de infecção das queimaduras. Estudos recentes sugerem que o uso tópico de heparina pode alcançar esses objetivos. Este estudo tem o objetivo de avaliar tempo de epitelização, dor e taxa de infecção, comparando o uso de heparina tópica ao uso de colagenase no tratamento de queimadura de segundo grau superficial de face e pescoço. MÉTODO: No total, 20 pacientes foram randomizados em dois grupos: grupo tratado com heparina sódica e grupo tratado com colagenase (controle). Os critérios de exclusão foram: história de sangramento, discrasia sanguínea, alergias ao produto, úlcera péptica ativa e queimadura há mais de 24 horas. O teste de Mann-Whitney foi utilizado para avaliar os resultados. A dor foi avaliada pela necessidade do uso de analgésicos opioides. RESULTADOS: A heparina não foi efetiva em diminuir o tempo de epitelização ou o uso de opioides, e a taxa de infecção não apresentou diferença estatística entre os grupos. CONCLUSÕES: A heparina pode ser usada com segurança no tratamento de queimadura de segundo grau superficial em face e pescoço, mas seus efeitos benéficos ainda precisam ser comprovados.

BACKGROUND: New treatment options for thermal injuries are very desirable, especially if they reduce healing time and pain without increase of infection rates. Recent studies suggest that heparin topical use can achieve those goals. This study has the objective to evaluate healing time, pain and infection rate comparing topical use of heparin and collagenase in the treatment of superficial second degree burns of face and neck. METHODS: Twenty patients were randomized into 2 groups: group treated with topical heparin and group treated with collagenase (control group). The exclusion criteria were: history of bleeding, blood discrasia, allergies to the product, active peptic ulcer and burns with more than 24 hours. Mann-Whitney test was applied to evaluate the results. The pain was measured by the use of opioid analgesics. RESULTS: The heparin was not effective in decrease of healing time nor the use of opioids, and the infection rate didn't present significant difference between the groups. CONCLUSIONS: The heparin can be used safely in treatment of superficial second degree burn of face and neck, but its beneficial effects need to be proven.

The vegetal biomembrane in the healing of chronic venous ulcers / Biomembrana vegetal na cicatrização de úlceras venosas crônicas

BACKGROUND: The vegetal biomembrane has been used to treat cutaneous ulcers. OBJECTIVES: To assess the role of the vegetal biomembrane on the chronic venous ulcers treatment compared to treatment with collagenase cream. METHODS: Fourteen patients were selected to be treated with vegetal biomembrane and 7 with Fibrase®(CONTROL), followed clinically and photographically by the Wound Healing Index by ImageJ during 120 days and biopsied on the 1st and 30th days for histological examination. RESULTS: The vegetal biomembrane was better in promoting healing of the ulcers, especially on the inflammatory phase, confirmed by abundant exudation and wound debridement than the CONTROL group, on the 30th day. There was a greater tendency to angiogenesis followed by re-epithelialization with highest wound healing index on the 90th and 120th days. CONCLUSION: A combined analysis of clinical and histopathological findings suggests that the vegetal biomembrane acted as a factor inducing wound healing, especially on the inflammatory phase, confirmed by abundant exudation of the lesions promoting the transformation of the microenvironment of the chronic venous ulcers, and also stimulating angiogenesis and subsequent re-epithelialization.

FUNDAMENTOS: A biomembrana vegetal tem sido usada para tratamento de úlceras cutâneas. OBJETIVOS: Avaliar a ação da biomembrana vegetal no tratamento de úlceras venosas crônicas, comparando-a ao tratamento à base de colagenase. MÉTODOS: Foram selecionados 14 pacientes tratados com biomembrana vegetal e sete com Fibrase® (grupo controle), acompanhados clínico-fotograficamente pelo índice de cicatrização das úlceras (ICU) por 120 dias, por meio do software ImageJ, e biopsiados no primeiro e 30º dias para estudo histopatológico. RESULTADOS: A biomembrana vegetal foi superior em relação ao controle na cicatrização das úlceras no 30º dia, especialmente na fase inflamatória, confirmada pela exsudação abundante e pelo desbridamento. Houve tendência superior à angiogênese seguida de reepitelização com maiores ICUs no 90º e 120º dias. CONCLUSÃO: A análise conjunta dos achados clínicos e histopatológicos sugere que a biomembrana vegetal atuou como um fator indutor da cicatrização, especialmente na fase inflamatória, confirmada pela exsudação abundante das lesões, promovendo a transformação do microambiente das úlceras venosas crônicas e estimulando a angiogênese e a posterior reepitelização.

Chemonucleolysis in lumbar disc herniation: a meta-analysis

PURPOSE: To carry out a systematic review and meta-analysis of the efficacy of chemonucleolysis in the treatment of lumbar disc herniation. METHODS: Clinical trials were selected from 3 electronic databases (The Cochrane Controlled Trials Register, MEDLINE, and EMBASE). Data were analyzed with the software STATA, using the meta command. RESULTS: Twenty-two clinical trials were eligible. For chemonucleolysis versus placebo, the summary risk ratio estimate for pain relief as outcome was 1.51 (95 percent CI: 1.27-1.80). The summary estimate was 1.07 (95 percent CI: 0.95-1.20) for the comparison between chymopapain and collagenase. Regarding chemonucleolysis with chymopapain versus surgery, the fixed-effect summary estimate of effect for pain relief was 0.93 (95 percent CI: 0.88-0.98) with surgery as the reference group. In this case, heterogeneity was statistically significant. CONCLUSIONS: Chemonucleolysis with chymopapain was superior to placebo and was as effective as collagenase in the treatment of lumbar disc prolapse. Results for studies comparing chemonucleolysis with surgery were heterogeneous, making it difficult to interpret the summary measure of effect.

OBJETIVO: Avaliar a eficácia da quimonucleólise no tratamento da hérnia de disco lombar por meio de uma metanálise de ensaios clínicos. MÉTODOS: Os ensaios clínicos foram selecionados de três bases de dados eletrônicas( Cochrane, MEDLINE, e EMBASE). Os dados foram analisados por intermédio do aplicativo STATA, com o comando meta. RESULTADOS: trabalhamos com 22 ensaios clínicos. Para a comparação entre quimonucleólise e placebo, a estimativa da razão de riscos, tendo melhora da dor como desfecho, foi de 1,51 (I 95 por cento C: 1,27-1,80). Aquela medida foi de 1,07 (I 95 por cento C: 0,95-1,20) para a comparação entre quimopapaína e colagenase. Em um modelo de efeitos fixos, a razão de risco, para melhora da dor, foi 0,93 (I 95 por cento C: 0,88-0,98), tendo a discectomia como grupo de referência. Nesse caso, um teste de heterogeneidade foi considerado estatisticamente significante. CONCLUSÕES: a eficácia da quimonucleólise foi superior à do placebo e semelhante à da colagenase. Os resultados dos estudos referentes à comparação entre quimonucleólise e cirurgia foram heterogêneos, o que implica interpretação não-trivial da medida de efeito.

Eficácia do açucar, colagenase e nitrofurazona no tratamento das infecçöes incisionais: estudo experimental em camundongos / The efficacy of sugar, colagenase and nitrofurazone used in infections of the surgical wound: experimental study on mices

O presente estudo objetivou verificar a eficácia de agentes tópicos comumente utilizados no tratamento das infecçöes da ferida operatória e sua possível interferência no processo cicatricial. Foram utilizados 48 camundongos suiços (Mus musculus) em idade adulta, com peso médio de 24 g. Os animais foram divididos em 2 grupos distintos, sendo no primeiro realizado uma iancisäo padronizada no dorso, inoculando-se a seguir uma cepa de Staphylococcus aureus (ATTC 6538), numa concentraçäo de 10.6 colônias por unidade (CPU). Num segundo grupo com igual número de animais foi realizada uma incisäo circular no dorso e implantada no tecido subcutâneo uma esponja de celulose. Os animais foram subdivididos em 4 subgrupos com 6 animais cada, de acordo com o tratamento administrado: soro fisiológico (controle), nitrofurazona, açucar e colagenase. O diâmetro da ferida foi mensurado diariamente. A secreçäo proveniente das feridas foi colhida no pós-operatório imediato, 3º, 7º e 14º dias de tratamento, 3 animais de cada subgrupo foram sacrificados e realizado exame histopatológico da área de lesäo. Nos animais implantados, na mesma ocasiäo foi removida a esponja e feita análise bioquímica. Com os dados obtidos procedeu-se a avaliaçäo estatística. Foi verificada rápida resoluçäo do processo infeccioso sem interferência no processo cicatricial nos grupos tratados com açucar e colagenase (p<0,05). Nossos resultados sugerem a seguinte ordem crescente de erradicaçäo da infecçäo sem interferência com a cicatrizaçäo: açucar, colagenase e nitrofurazona (p<0,05)

Uma nova associaçäo antimicrobiana no desbridamento enzimático com colagenase / A new antimicrobial association in the enzymatic debridment with collagenase

A substituiçao do Cloranfenicol pela Gentamicina, associada à colagenase Clostridium peptidase A mostrou-se vantajosa na eliminaçao da escara em 66 doentes portadores de lesoes causadas por patologias diversas. Esta eliminaçao foi mais eficaz por sua precocidade, homogeneidade, facilidade e sobretudo por provocar a diminuiçao da flora patogênica local.