Silk Bioprotein as a Novel Surgical-Site Wound Dressing: A Prospective, Randomized, Single-Blinded, Superiority Clinical Trial

丝素蛋白作为一种新型手术部位伤口敷料:一项前瞻性、随机、单盲、优效性临床试验

阅读:2

Abstract

BACKGROUND: Medical adhesive-related skin injuries (MARSIs) affect about 1.5 million patients annually in the United States. Complications include allergic contact dermatitis, skin blistering, skin tears, and surgical-site infections (SSIs). The authors hypothesize that a natural hypoallergenic silk bioprotein wound dressing will decrease the incidence of MARSI in comparison to a synthetic alternative. OBJECTIVES: This study aimed to assess the efficacy and safety of a silk bioprotein wound dressing compared to the Dermabond Prineo (Ethicon, Inc., Somerville, NJ) skin closure system. METHODS: This prospective, randomized, single-blinded trial studied 25 patients who were dressed with Dermabond Prineo on one side of their body and on the contralateral side with the silk bioprotein dressing after undergoing abdominoplasty or reduction mammaplasty procedures. Data were collected over 5 postoperative visits using photographs and an investigator administered questionnaire to track rash, itch, discomfort, erythema, edema, SSIs, need for pharmaceutical intervention, mechanical injury, removal time, and bathing routines. RESULTS: Sixty-four percent (16/25) of patients characterized the severity of discomfort as a score of 4 out of 10 or greater on the Dermabond Prineo control side and only 4% (1/25) for the silk-dressing side (P < .001). Fifty-two percent (13/25) had a visible rash of 4 or higher on the Dermabond Prineo side of their incision and 0% (0/25) had a rash on the silk side (P < .001). Fifty-two percent (13/25) required steroids or antibiotics to treat MARSI to Dermabond Prineo and 0% (0/25) required pharmaceutical intervention on the silk side (P < .001). CONCLUSIONS: The use of a silk bioprotein wound dressing significantly reduces the incidence of MARSI throughout the postoperative period.

特别声明

1、本页面内容包含部分的内容是基于公开信息的合理引用;引用内容仅为补充信息,不代表本站立场。

2、若认为本页面引用内容涉及侵权,请及时与本站联系,我们将第一时间处理。

3、其他媒体/个人如需使用本页面原创内容,需注明“来源:[生知库]”并获得授权;使用引用内容的,需自行联系原作者获得许可。

4、投稿及合作请联系:info@biocloudy.com。