{"title":"这是一项开放标签、单一中心、上市后临床研究，旨在评估新型抗菌伤口敷料（VELVERT）作为静脉性腿部溃疡辅助疗法的安全性和有效性。","authors":"Sudhir Kumar, Suvash Sahu, Shivam Sharma","doi":"10.1177/02683555241288729","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>An open label, single-centric, post market clinical study was undertaken to evaluate the safety and efficacy of a new antimicrobial wound dressing (VELVERT) as an adjuvant therapy in the treatment of venous leg ulcer (VLU).</p><p><strong>Methods: </strong>Patients with VLU of grade C-5 according to CEAP classification and above were evaluated using doppler ultra sound. The efficacy of new antimicrobial wound dressing (VELVERT) was assessed in terms of wound area reduction within a time frame of 60 days and surgeon questioners. Patients were evaluated for VELVERT safety and pain level on a scale of 0-10 Numeric Pain Chart. Presence of micro-organism load was monitored at regular time interval.</p><p><strong>Results: </strong>VELVERT treatment was effective as 71.43% reduction in the ulcer area was observed. After 60 days, a total of 9 (45%) patients had complete ulcer closure. A remarkable decrease in the severity of pain was observed with 11 (55%) patients expressing no pain at the EOT. Swab test showed negative result for micro-organism growth. No serious adverse events were observed during the trial.</p><p><strong>Conclusion: </strong>The data indicates that VELVERT is an effective treatment for VLUs and showed the potential in the wound care of VLUs.</p>","PeriodicalId":94350,"journal":{"name":"Phlebology","volume":" ","pages":"2683555241288729"},"PeriodicalIF":0.0000,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"An open label, single-centric, post market clinical study to evaluate the safety and efficacy of a new antimicrobial wound dressing (VELVERT) as an adjuvant therapy in the treatment of venous leg ulcer.\",\"authors\":\"Sudhir Kumar, Suvash Sahu, Shivam Sharma\",\"doi\":\"10.1177/02683555241288729\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>An open label, single-centric, post market clinical study was undertaken to evaluate the safety and efficacy of a new antimicrobial wound dressing (VELVERT) as an adjuvant therapy in the treatment of venous leg ulcer (VLU).</p><p><strong>Methods: </strong>Patients with VLU of grade C-5 according to CEAP classification and above were evaluated using doppler ultra sound. The efficacy of new antimicrobial wound dressing (VELVERT) was assessed in terms of wound area reduction within a time frame of 60 days and surgeon questioners. Patients were evaluated for VELVERT safety and pain level on a scale of 0-10 Numeric Pain Chart. Presence of micro-organism load was monitored at regular time interval.</p><p><strong>Results: </strong>VELVERT treatment was effective as 71.43% reduction in the ulcer area was observed. After 60 days, a total of 9 (45%) patients had complete ulcer closure. A remarkable decrease in the severity of pain was observed with 11 (55%) patients expressing no pain at the EOT. Swab test showed negative result for micro-organism growth. No serious adverse events were observed during the trial.</p><p><strong>Conclusion: </strong>The data indicates that VELVERT is an effective treatment for VLUs and showed the potential in the wound care of VLUs.</p>\",\"PeriodicalId\":94350,\"journal\":{\"name\":\"Phlebology\",\"volume\":\" \",\"pages\":\"2683555241288729\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-10-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Phlebology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1177/02683555241288729\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Phlebology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1177/02683555241288729","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
An open label, single-centric, post market clinical study to evaluate the safety and efficacy of a new antimicrobial wound dressing (VELVERT) as an adjuvant therapy in the treatment of venous leg ulcer.
Objectives: An open label, single-centric, post market clinical study was undertaken to evaluate the safety and efficacy of a new antimicrobial wound dressing (VELVERT) as an adjuvant therapy in the treatment of venous leg ulcer (VLU).
Methods: Patients with VLU of grade C-5 according to CEAP classification and above were evaluated using doppler ultra sound. The efficacy of new antimicrobial wound dressing (VELVERT) was assessed in terms of wound area reduction within a time frame of 60 days and surgeon questioners. Patients were evaluated for VELVERT safety and pain level on a scale of 0-10 Numeric Pain Chart. Presence of micro-organism load was monitored at regular time interval.
Results: VELVERT treatment was effective as 71.43% reduction in the ulcer area was observed. After 60 days, a total of 9 (45%) patients had complete ulcer closure. A remarkable decrease in the severity of pain was observed with 11 (55%) patients expressing no pain at the EOT. Swab test showed negative result for micro-organism growth. No serious adverse events were observed during the trial.
Conclusion: The data indicates that VELVERT is an effective treatment for VLUs and showed the potential in the wound care of VLUs.
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