- CRITERIA FOR CLASSIFICATION AS A PROTEIN SCAFFOLD SERIES
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- CRITERIA FOR CLASSIFICATION AS A PROTEIN SCAFFOLD FREE
8–10īreast reconstruction using free or pedicled transverse rectus abdominis muscle (TRAM) flaps or deep inferior epigastric artery perforator (DIEP) flaps inherently violates the rectus fascia and can similarly result in abdominal wall herniation or bulge formation in approximately 2% to 9% 11, 12 and 4% to 33% 13 of patients, respectively. 5–7 However, tissue-derived mesh has several shortcomings such as storage and handling requirements, elasticity, animal origin, product variability, cost, and device failure. 3, 4 Recently, tissue-based bioprosthetic mesh has gained popularity for its use in complex abdominal wall reconstructions (AWRs) owing to lower rates of mesh infection, fistula formation, and mesh explantation than the rates reported for AWRs with synthetic mesh. 2 In prospective randomized controlled trials, incisional hernia repair reinforced with prosthetic mesh is associated with better outcomes than incisional hernia repair without prosthetic mesh reinforcement. 1 For ventral hernia repair, the rates of bulge formation and hernia reoperation vary greatly within the literature, between 6% and 50% depending on the complexity of the defect, repair technique, and patient factors including tissue integrity and comorbid conditions. Violation of abdominal wall fascial integrity can be associated with significant morbidity, including abdominal hernia and contour deformity. Procedure-specific outcome studies are warranted to delineate optimal patient selection and define potential device characteristic advantages.
CRITERIA FOR CLASSIFICATION AS A PROTEIN SCAFFOLD SERIES
To our knowledge, this is the only series to report on a long-lasting, transitory SBS for abdominal wall repair and reinforcement. Postoperative complication rates after 18 months were low, and most surgical complications were managed nonoperatively on an outpatient basis without mesh removal. The overall complication rate was 6.5%, consisting of 2 wound dehiscences, 1 with device exposure, 1 seroma, 1 infection with explantation, and a perioperative bulge requiring reoperation. Procedures using an SBS included reinforcement of an abdominal-based flap donor site (31.2%), ventral hernia repair (53.2%), and abdominoplasty (15.6%). Of those, 77 patients underwent abdominal wall fascial repair, with a mean follow-up of 18.4 ± 7.5 months. We reviewed the records of 172 consecutive patients who received an SBS for soft-tissue support. Indications, comorbid conditions, surgical technique, complications, and outcomes were evaluated. We conducted a multicenter retrospective review of all consecutive patients who underwent abdominal wall soft-tissue reinforcement with an SBS device between 20. The safety and effectiveness of a long-lasting, transitory, 510(k)-cleared purified silk fibroin biologic scaffold (SBS) are investigated for soft-tissue support and repair of the abdominal wall. Preclinical studies have demonstrated that macroporous silk fibroin protein scaffolds are capable of promoting physiologically durable supportive tissue, which favors application of these engineered tissues for clinical implantation. The work cannot be changed in any way or used commercially.
CRITERIA FOR CLASSIFICATION AS A PROTEIN SCAFFOLD DOWNLOAD
This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 3.0 License, where it is permissible to download and share the work provided it is properly cited. Clemens, MD Department of Plastic Surgery Unit 1488 The University of Texas MD Anderson Cancer Center 1515 Holcombe Boulevard Houston TX 77030 E-mail: The Article Processing Charge was paid for by the authors. Clemens, Downey, Kind, Jewel, Lehfeldt, Marshall, Agullo, Palladino, and Bengtson are consultants and investigators for Allergan Corporation. Received for publication accepted September 16, 2014.ĭisclosure: Drs. §§Michigan State University, Grand Rapids, Mich. ‡‡Bengtson Center for Aesthetics and Plastic Surgery, Grand Rapids, Mich. ††Division of Plastic Surgery, Oregon Health and Science University, Portland, Ore. **Marshall Cosmétique Center, Miami, Fla. ‖Kind-Chang Plastic Surgery, California-Pacific Medical Center, San Francisco, Calif.
¶Teleos Plastic Surgery, Pasadena, Calif. Foster School of Medicine, Texas Tech University Health Sciences Center, El Paso, Tex. ‡Southwest Plastic Surgery, El Paso, Tex. †Department of Plastic Surgery, University of Southern California, Keck School of Medicine, Los Angeles, Calif. From the *Department of Plastic Surgery, MD Anderson Cancer Center, The University of Texas, Houston, Tex.
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