Randomized, Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Fibrin Sealant VH S/D 4 s-apr (Artiss) to Improve Tissue Adherence in Subjects Undergoing Rhytidectomy
| العنوان: | Randomized, Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Fibrin Sealant VH S/D 4 s-apr (Artiss) to Improve Tissue Adherence in Subjects Undergoing Rhytidectomy |
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| المؤلفون: | James R. Shire, T. Roderick Hester, Jason Diamond, Steve Zvi Abrams, Davis B. Nguyen, Rod J. Rohrich, Zachary E. Gerut, Julian C. Desmond, Achih H. Chen, Laura Silvati-Fidell |
| المصدر: | Aesthetic Surgery Journal. 33:487-496 |
| بيانات النشر: | Oxford University Press (OUP), 2013. |
| سنة النشر: | 2013 |
| مصطلحات موضوعية: | Adult, Male, medicine.medical_specialty, medicine.medical_treatment, Phases of clinical research, Fibrin Tissue Adhesive, Surgical Flaps, Fibrin, Postoperative Complications, Hematoma, Tensile Strength, Multicenter trial, medicine, Humans, Single-Blind Method, Prospective Studies, Abscess, Adverse effect, Aged, Wound Healing, biology, business.industry, General Medicine, Middle Aged, medicine.disease, Skin Aging, Surgery, Seroma, Rhytidoplasty, biology.protein, Drainage, Female, Tissue Adhesives, business, Rhytidectomy |
| الوصف: | Background: Suction drains are commonly placed after rhytidectomy to avoid seroma formation that may result from dead spaces between skin layers. Fibrin sealants promote tissue adherence by crosslinking with extracellular matrix proteins, which may reduce the dead space under skin flaps. Objectives: The authors evaluate the safety and efficacy of the fibrin sealant (FS) VH S/D 4 s-apr (Artiss; Baxter Healthcare Corp, Deerfield, Illinois), added to standard-of-care (SoC) treatment, in improving flap adherence and reducing dead space in patients undergoing rhytidectomy. Methods: Patients with planned facial rhytidectomy were enrolled in this phase 3, prospective, controlled, randomized, patient-blinded, multicenter trial. They received SoC treatment on 1 side of the face and adjunctive FS VH S/D 4 s-apr on the other. Results: Seventy-five patients completed the trial. The mean (SD) drainage volume was 7.7 (7.4) mL from the sides treated with sealant and 20.0 (11.3) mL from the SoC-only sides ( P < .0001). Rates of hematoma and seroma were similar for the 2 treatments, as were changes in postoperative skin sensitivity. Adverse events generally were mild; 2 serious adverse events were reported (wound abscess, dehydration). Conclusions: Adjunct use of FS VH S/D 4 s-apr in rhytidectomy was proven safe in this study. It significantly reduced drainage volumes without increasing the incidence of hematoma or seroma, which suggests that it eliminates dead space through improved flap adherence. Level of Evidence: 2 ![Graphic][1] [1]: /embed/inline-graphic-1.gif |
| تدمد: | 1527-330X 1090-820X |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::537fc9c6284489a90b25c19cf0536224 https://doi.org/10.1177/1090820x13479969 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....537fc9c6284489a90b25c19cf0536224 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 1527330X 1090820X |
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