In Vivo Comparison of MONOFIX,A Novel Barbed Suture with a Triangular Stopper,with Pre-existing Products in a Porcine Model |
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| Institution: | 1. Departments of Obstetrics and Gynecology (Drs. J. Kim, Jeong, M. S. Kim, B.-G. Kim, Bae, and Lee);2. Pathology and Translational Genomics (Dr. Shin), Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea;3. Medical Device Program (Ms. Yoon);4. Biology & Clinical Department (Dr. In);5. Samyang Biopharmaceuticals Corporation, Sungnam-si, Korea, and Medical Device Plant (Ms. Eom), Samyang Biopharmaceuticals, Daejeon, Korea.;1. Division of Gynecologic Oncology, Department of Obstetrics and Gynecology (Drs. Renz, Diver, English, Dorigo, and Karam);2. Department of Radiation Oncology (Dr. Kidd), Stanford University School of Medicine, Stanford, California;1. Department of Obstetrics and Gynecology (Dr. Munro), David Geffen School of Medicine at UCLA, Los Angeles, California;2. Kaiser Permanente (Drs. Munro and Saadat), Los Angeles Medical Center, Los Angeles, California;3. Scripps Clinic (Drs. Brown and Kahn), San Diego, California;4. Division of Minimally Invasive Gynecology Surgery, Department of Obstetrics & Gynecology (Dr. Gomez), University of Nevada Las Vegas School of Medicine, Las Vegas, Nevada;5. Las Vegas Minimally Invasive Surgery (Drs. Howard, Stockwell, and Volker), Las Vegas, Nevada;6. Department of Obstetrics & Gynecology (Dr. Advincula), Columbia University, New York, New York;7. Kryterion Inc. (Dr. Thayn), Phoenix, Arizona |
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| Abstract: | Study ObjectiveMONOFIX, a new absorbable barbed suture device, has a triangular stopper at the end to hold the suture to the tissue without hooking the looped end or knotting. The aim of this study was to compare the biomechanical strength and histologic features of MONOFIX with other barbed suture devices using a porcine model.DesignWell-designed, controlled trial without randomization.SettingAnimal laboratory in university hospital.SubjectsSixteen, 60-kg, mature female domestic pigs (skin closure group) and 5, 60-kg, mature female domestic pigs (fascial closure group).InterventionsIn the skin closure group, 3-0 MONOFIX versus 2 widely used 3-0 absorbable barbed sutures (3-0 V-Loc 180 or Stratafix). In the fascial closure group, 2-0 MONOFIX versus 1 widely used 2-0 absorbable barbed sutures (2-0 Stratafix).Measurements and Main ResultsIn the skin closure group, the biomechanical wound strength of skin sutured with size 3-0 MONOFIX, V-Loc 180, or Stratafix was evaluated by postoperative day assessment (days 0, 3, 7, 14, and 28). In the fascial closure group, pigs underwent 2 paramedian incisions and were sutured with 2-0 MONOFIX or with 2-0 Stratafix to evaluate histologic reaction. At 6 weeks the tissues around the suture line were excised and microscopically evaluated. The biomechanical strength of the MONOFIX had similar tissue tensile strength compared with the control, regardless of postoperative day. In the fascial closure model, there was no significant difference in the average tissue reaction score between MONOFIX and Stratafix (1.2 ± .3 vs 1.3 ± .3, p = .478).ConclusionThis study demonstrated that MONOFIX has equivalent tensile strength and histologic reaction when compared with commonly used barbed suture devices. Accordingly, this preclinical study suggests that the use of MONOFIX is a safe alternative to other barbed suture devices. |
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