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Clinical Evaluation of the Efficacy and Tolerability of Rigenase(®) and Polyhexanide (Fitostimoline(®) Plus) vs. Hyaluronic Acid and Silver Sulfadiazine (Connettivina(®) Bio Plus) for the Treatment of Acute Skin Wounds: A Randomized Trial
Objectives: Compare the efficacy and tolerability of Connettivina(®) Bio Plus (Group A) gauze and cream, and Fitostimoline(®) Plus (Group B) gauze and cream for the treatment of acute superficial skin lesions. Design: Single-center, parallel, randomized trial. A block randomization method was used....
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9105357/ https://www.ncbi.nlm.nih.gov/pubmed/35566643 http://dx.doi.org/10.3390/jcm11092518 |
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author | Russo, Raffaele Carrizzo, Albino Barbato, Alfonso Rasile, Barbara Rosa Pentangelo, Paola Ceccaroni, Alessandra Marra, Caterina Alfano, Carmine Losco, Luigi |
author_facet | Russo, Raffaele Carrizzo, Albino Barbato, Alfonso Rasile, Barbara Rosa Pentangelo, Paola Ceccaroni, Alessandra Marra, Caterina Alfano, Carmine Losco, Luigi |
author_sort | Russo, Raffaele |
collection | PubMed |
description | Objectives: Compare the efficacy and tolerability of Connettivina(®) Bio Plus (Group A) gauze and cream, and Fitostimoline(®) Plus (Group B) gauze and cream for the treatment of acute superficial skin lesions. Design: Single-center, parallel, randomized trial. A block randomization method was used. Setting: University of Salerno—AOU San Giovanni di Dio e Ruggi d’Aragona. Participants: Sixty patients were enrolled. All patients fulfilled the study requirements. Intervention: One application of the study drugs every 24 h, and a six-week observation period. Main outcome measures: Efficacy and tolerability of the study drugs. Results: In total, 60 patients (Group A, n = 30; Group B, n = 30) were randomized; mean age was 58.5 ± 15.8 years. All patients were included in the outcome analysis. Total wound healing was achieved in 17 patients undergoing treatment with Connettivina(®) Bio Plus and 28 patients undergoing treatment with Fitostimoline(®) Plus. The greater effectiveness of the latter was significant (p = 0.00104). In Group B, a significantly greater degree of effectiveness was observed in reducing the fibrin in the wound bed (p = 0.04746). Complications or unexpected events were not observed. Conclusions: Both Connettivina(®) Bio Plus and Fitostimoline(®) Plus are secure and effective for treating acute superficial skin lesions. Fitostimoline(®) Plus was more effective than Connettivina(®) Bio Plus in wound healing of acute superficial skin lesions, especially if fibrin had been observed in the wound bed. |
format | Online Article Text |
id | pubmed-9105357 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-91053572022-05-14 Clinical Evaluation of the Efficacy and Tolerability of Rigenase(®) and Polyhexanide (Fitostimoline(®) Plus) vs. Hyaluronic Acid and Silver Sulfadiazine (Connettivina(®) Bio Plus) for the Treatment of Acute Skin Wounds: A Randomized Trial Russo, Raffaele Carrizzo, Albino Barbato, Alfonso Rasile, Barbara Rosa Pentangelo, Paola Ceccaroni, Alessandra Marra, Caterina Alfano, Carmine Losco, Luigi J Clin Med Article Objectives: Compare the efficacy and tolerability of Connettivina(®) Bio Plus (Group A) gauze and cream, and Fitostimoline(®) Plus (Group B) gauze and cream for the treatment of acute superficial skin lesions. Design: Single-center, parallel, randomized trial. A block randomization method was used. Setting: University of Salerno—AOU San Giovanni di Dio e Ruggi d’Aragona. Participants: Sixty patients were enrolled. All patients fulfilled the study requirements. Intervention: One application of the study drugs every 24 h, and a six-week observation period. Main outcome measures: Efficacy and tolerability of the study drugs. Results: In total, 60 patients (Group A, n = 30; Group B, n = 30) were randomized; mean age was 58.5 ± 15.8 years. All patients were included in the outcome analysis. Total wound healing was achieved in 17 patients undergoing treatment with Connettivina(®) Bio Plus and 28 patients undergoing treatment with Fitostimoline(®) Plus. The greater effectiveness of the latter was significant (p = 0.00104). In Group B, a significantly greater degree of effectiveness was observed in reducing the fibrin in the wound bed (p = 0.04746). Complications or unexpected events were not observed. Conclusions: Both Connettivina(®) Bio Plus and Fitostimoline(®) Plus are secure and effective for treating acute superficial skin lesions. Fitostimoline(®) Plus was more effective than Connettivina(®) Bio Plus in wound healing of acute superficial skin lesions, especially if fibrin had been observed in the wound bed. MDPI 2022-04-29 /pmc/articles/PMC9105357/ /pubmed/35566643 http://dx.doi.org/10.3390/jcm11092518 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Russo, Raffaele Carrizzo, Albino Barbato, Alfonso Rasile, Barbara Rosa Pentangelo, Paola Ceccaroni, Alessandra Marra, Caterina Alfano, Carmine Losco, Luigi Clinical Evaluation of the Efficacy and Tolerability of Rigenase(®) and Polyhexanide (Fitostimoline(®) Plus) vs. Hyaluronic Acid and Silver Sulfadiazine (Connettivina(®) Bio Plus) for the Treatment of Acute Skin Wounds: A Randomized Trial |
title | Clinical Evaluation of the Efficacy and Tolerability of Rigenase(®) and Polyhexanide (Fitostimoline(®) Plus) vs. Hyaluronic Acid and Silver Sulfadiazine (Connettivina(®) Bio Plus) for the Treatment of Acute Skin Wounds: A Randomized Trial |
title_full | Clinical Evaluation of the Efficacy and Tolerability of Rigenase(®) and Polyhexanide (Fitostimoline(®) Plus) vs. Hyaluronic Acid and Silver Sulfadiazine (Connettivina(®) Bio Plus) for the Treatment of Acute Skin Wounds: A Randomized Trial |
title_fullStr | Clinical Evaluation of the Efficacy and Tolerability of Rigenase(®) and Polyhexanide (Fitostimoline(®) Plus) vs. Hyaluronic Acid and Silver Sulfadiazine (Connettivina(®) Bio Plus) for the Treatment of Acute Skin Wounds: A Randomized Trial |
title_full_unstemmed | Clinical Evaluation of the Efficacy and Tolerability of Rigenase(®) and Polyhexanide (Fitostimoline(®) Plus) vs. Hyaluronic Acid and Silver Sulfadiazine (Connettivina(®) Bio Plus) for the Treatment of Acute Skin Wounds: A Randomized Trial |
title_short | Clinical Evaluation of the Efficacy and Tolerability of Rigenase(®) and Polyhexanide (Fitostimoline(®) Plus) vs. Hyaluronic Acid and Silver Sulfadiazine (Connettivina(®) Bio Plus) for the Treatment of Acute Skin Wounds: A Randomized Trial |
title_sort | clinical evaluation of the efficacy and tolerability of rigenase(®) and polyhexanide (fitostimoline(®) plus) vs. hyaluronic acid and silver sulfadiazine (connettivina(®) bio plus) for the treatment of acute skin wounds: a randomized trial |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9105357/ https://www.ncbi.nlm.nih.gov/pubmed/35566643 http://dx.doi.org/10.3390/jcm11092518 |
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