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Therapeutic Potential of a Biodynamic Supplement on Skin Pressure Ulcers: A Randomized Clinical Study.

ABSTRACT: Pressure ulcers (PUs) are a debilitating and often painful condition. They are localized lesions on the skin and/or underlying tissues and are common in the elderly, people with mobility difficulties, diabetics, and vascular disease or malnutrition, as well as in those requiring intensive or palliative care. The prevention and treatment of PUs involve strategies to optimize hydration, circulation, and nutrition. Nutrition plays a key role in pressure ulcer care because wounds require macronutrients and micronutrients to heal. Reports relating to the effectiveness of "Complementary Enzyme Therapy" also in the vulnological field led us to this study, the aim of which was to test the activity of a biodynamic food supplement (Citozym^®) rich in carbohydrates, vitamins, and amylase and lactase and characterized by marked antioxidant activity. Citozym^® administered topically and/or systemically, and in particular in both administrations, in patients suffering from Pus, has shown a marked reduction in bedsores and, in many cases, complete healing. Furthermore, it was possible to observe a lower incidence of side effects compared to conventional therapies. The results obtained, confirmed by various tests and recognized by the scientific community, allow us to conclude that treatment with Citozym^® could represent a new and effective strategy for the treatment of PUs.

SUBMITTER: Ferorelli P

PROVIDER: S-EPMC11351901 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Therapeutic Potential of a Biodynamic Supplement on Skin Pressure Ulcers: A Randomized Clinical Study.

Ferorelli Pasquale P Doepp Manfred M Lenzi Stefano S Rovelli Roberto R Gisonna Gennaro G Maierà Giuseppe G Antonelli Francesco F Radaelli Massimo M Shevchenko Anna A Feriotto Giordana G Mischiati Carlo C Borromeo Ilaria I Beninati Simone S

Biomedicines 20240822 8

Pressure ulcers (PUs) are a debilitating and often painful condition. They are localized lesions on the skin and/or underlying tissues and are common in the elderly, people with mobility difficulties, diabetics, and vascular disease or malnutrition, as well as in those requiring intensive or palliative care. The prevention and treatment of PUs involve strategies to optimize hydration, circulation, and nutrition. Nutrition plays a key role in pressure ulcer care because wounds require macronutrie ...[more]

PMID: 39200385

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Project description:BackgroundNegative pressure wound therapy (NPWT) with instillation (NPWTi) is a new treatment for chronic skin ulcers (CSUs), but the choice of perfusate is still investigated. The clinical application of Huoxue Shengji (HXSJ) decoction has been proved to promote the formation of granulation. The formation of fresh granulation, angiogenesis, and proliferation of vascular endothelial cells are closely related. The purpose of this study was to observe the clinical efficacy of NWPT with HXSJ decoction instillation in the treatment of CSUs and to explore the potential mechanism by which HXSJ decoction promotes proliferation of vascular endothelial cells at the cellular level.MethodsIn the clinical study, the random number table was used to divide the patients into three groups (patients were numbered by visit time and assigned a random number and grouped by the remainder after the random number was divided by 3, and when the number of patients in one group reached 20, the enrolment of this group is stopped), including NPWT combined with HXSJ decoction instillation (group A), NPWT combined with normal saline instillation (group B), and NPWT (group C). Related indexes were examined, including the wound cavity volume, bacterial culture, histopathology examination, time periods of debridement, repair methods, and the time of ulcer healing. In the basic research, the effect of HXSJ decoction on the proliferation of HUVECs was analysed by CCK-8 assay and RT-PCR and western blot were used to quantify the VEGF and VEGFR-2 expression in the relevant signalling pathway.ResultsThere was no significant difference in the improvement rate of invasive cavity volume (P > 0.05) between groups A and B, but a significant difference was observed between groups A and C (P < 0.05). There was no significant difference in microbial reduction among groups (all P > 0.05). Histopathological examination showed that the microvascular count in group A was significantly higher than that in groups B and C (both P < 0.01) and there was no statistical difference between groups B and C (P > 0.05). There were no significant differences in the number of invasive lesions and repair methods among the groups (all P > 0.05). The healing time of group A was significantly faster than those of groups B and C (compared to group B, P < 0.05; compared to group C, P < 0.01), and there was no statistical difference between groups B and C (P > 0.05). In the cellular experiments, concentration screening was performed and 125 μg/mL HXSJ decoction showed the most significant effect on the proliferation of HUVECs and also enhanced the expression of VEGF and VEGFR-2.ConclusionHXSJ decoction can enhance the expression of VEGF and VEGFR-2 and promote the proliferation of HUVECs. Treatment with NWPT with HXSJ decoction instillation can further reduce the wound cavity volume; meanwhile, it can promote blood vessel formation in ulcer wounds, thus accelerating the healing of CSUs.

Project description:Pressure ulcers (PU) are caused by persistent long-term pressure, which compromises the integrity of the epidermis, dermis, and subcutaneous adipose tissue layer by layer, making it difficult to heal. Platelet products such as platelet lysate (PL) can promote tissue regeneration by secreting numerous growth factors based on clinical studies on skin wound healing. However, the components of PL are difficult to retain in wounds. Gelatin methacrylate (GelMA) is a photopolymerizable hydrogel that has lately emerged as a promising material for tissue engineering and regenerative medicine. The PL liquid was extracted, flow cytometrically detected for CD41a markers, and evenly dispersed in the GelMA hydrogel to produce a surplus growth factor hydrogel system (PL@GM). The microstructure of the hydrogel system was observed under a scanning electron microscope, and its sustained release efficiency and biological safety were tested in vitro. Cell viability and migration of human dermal fibroblasts, and tube formation assays of human umbilical vein endothelial cells were applied to evaluate the ability of PL to promote wound healing and regeneration in vitro. Real-time polymerase chain reaction (PCR) and western blot analyses were performed to elucidate the skin regeneration mechanism of PL. We verified PL's therapeutic effectiveness and histological analysis on the PU model. PL promoted cell viability, migration, wound healing and angiogenesis in vitro. Real-time PCR and western blot indicated PL suppressed inflammation and promoted collagen I synthesis by activating STAT3. PL@GM hydrogel system demonstrated optimal biocompatibility and favorable effects on essential cells for wound healing. PL@GM also significantly stimulated PU healing, skin regeneration, and the formation of subcutaneous collagen and blood vessels. PL@GM could accelerate PU healing by promoting fibroblasts to migrate and secrete collagen and endothelial cells to vascularize. PL@GM promises to be an effective and convenient treatment modality for PU, like chronic wound treatment.

Project description:ObjectiveEarly bonding by skin-to-skin contact (SSC) has been demonstrated to be beneficial for mothers and newborns following vaginal delivery. The aim of this study was to investigate the impact of intraoperative bonding (early SSC) after cesarean section on neonatal adaptation, maternal pain and stress response.Study designThis prospective, randomized-controlled pilot study was performed at a single academic tertiary hospital (Department of Obstetrics and Gynecology, Medical University of Graz, Austria) between September 2013 and January 2014. Women were randomly assigned to intraoperative ("early") SCC (n = 17) versus postoperative ("late") SCC (n = 18). Main variables investigated were neonatal transition (Apgar score, arterial oxygen saturation, heart rate and temperature), maternal pain perception and both maternal and neonatal stress response by measuring the stress biomarkers salivary free cortisol and salivary alpha amylase.ResultsThere was no evidence for differences in parameters reflecting neonatal transition or stress response between the 'Early SSC Group' and the 'Late SSC Group'. Maternal salivary cortisol and alpha-amylase levels as well as maternal wellbeing and pain did not differ between the groups. However, the rise of maternal salivary alpha-amylase directly after delivery was higher in the 'Early SSC Group' compared to the 'Late SSC Group' (p = 0.004).ConclusionsThis study did not reveal significant risks for the newborn in terms of neonatal transition when early SSC is applied in the operating room. Maternal condition and stress marker levels did not differ either, although the rise of maternal salivary alpha-amylase directly after delivery was higher in the 'Early SSC Group' compared to the 'Late SSC Group', which may indicate a stressor sign due to intensive activation of the sympathetic-adreno-medullary-system. This needs to be further evaluated in a larger prospective randomized trial.Trial registrationClinicalTrials.gov NCT01894880.

Dataset Information

Therapeutic Potential of a Biodynamic Supplement on Skin Pressure Ulcers: A Randomized Clinical Study.

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Therapeutic Potential of a Biodynamic Supplement on Skin Pressure Ulcers: A Randomized Clinical Study.

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