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TEMPLATE DESIGN © Clinical Usefulness and Safety of the Anti-bacterial coated multifilament suture (Vicryl Plus®) and Monofilament Suture (Monosyn®) in Hysterectomy Shin-Wha Lee, Hye-Sung Won, Yong-Man Kim, Ahm Kim Department of Obstetrics and Gynecology, College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Korea. Objectives The objective of this clinical trial was to evaluate the safety and usefulness of Monosyn®, a synthetic absorbable monofilament, in the field of obstetrics and gynecology in Korean women. This study, a phase IV clinical trial, included 50 patients who underwent total open hysterectomy or total laparoscopic hysterectomy from October 1, 2007 to March 31, 2008 in the Department of Obstetrics and Gynecology of Seoul Asan Medical Center. Vicryl Plus® was used as a comparison group of Monosyn. When stitching the stump after performing hysterectomy, we used the subject Monosyn or the comparison Vicryl Plus. Conclusions References Monosyn had the characteristics suitable for hysterectomy in terms of knot security, knot breaking load, and placing property, and showed better results for the prevention of postoperative wound infection. Therefore, it is believed that Monosyn can be used as a suture that can replace the Chromic catgut and Vicryl®, which have been widely used in gynecologic surgery. OPTIONAL LOGO HERE 1. Ray JA, Doddi N, Regula D, Williams JA, Melveger A, Poly dioxanone (PDS), a novel monofilament synthetic absorbable suture. Surg Gynecol Obstet 1981;153: Bezwada RS, Jamiokowski DD, Lee IY, Agarwal V, Persiva le J, Trenka-Benthin S, Emeta M, Suryadevara J, Yang A, Liu S. Monocryl suture, a new ultra-pliable absorbable monofilam ent suture. Biomaterials 1995;16: Rodeheaver GT, Beltran KA, Green CW, Faulkner BC, Stil es BM, Stanimir GW, Traeland H, Fried GM, Brown HC, Edlic h RF. Biomechanical and clinical performance of a new synth etic monofilament absorbable suture. J Long Term Eff Med I mplants 1996;6: Laufman H, Rubel T. Synthetic absorbable sutures. Surg G ynecol Obstet 1977;145: Olah A, Belagyi T, Neuberger G, Gamal EM. Use of differe nt absorbable sutures for continuous single-layer anastomosi s in the gastrointestinal tract. A prospective, randomized stud y. Dig Surg 2000;17: Rout WR. Gastrointestinal suturing. In: Zuidema GD. Shac kelford’s Surgery of the Alimentary Tract. 4 th ed. Philadelphia: WB Saunders, 1996; Katz AR, Mukherjee DP, Kaganov AL, Gordon S. A new sy nthetic monofilament absorbable suture made from polytrimet hylene carbonate. Surg Gynecol Obstet 1985;161: Methods Results LAVH, laparoscopy-assisted vaginal hysterectomy; TAH, total abdominal hysterectomy * median (range, min-max) ** mean±standard deviation *** Mann-Whitney test † 1 case of vaginal stump dehiscence Monosyn® group * (n=25) Vicryl Plus® Group * (n=25) p value ** Placement of 1 st knot3.2±0.53.1± Knot safety3.2±0.53.1± Knot running3.7±0.53.3±0.6<0.05 Knot tensile strength3.6±0.62.8±0.5<0.05 Tissue passage3.2± Visibility of suture3.5±0.53.4± Handling in general2.9±0.73.6±0.5<0.05 Table 1. Chracteristics of Monosyn ® Group and Vicryl Plus® Group in case of hysterectomy Monosyn ® group (n=25) Vicryl Plus® Group (n=25) p value *** Age (year) * 46 (37-74)45 (33-64)0.394 Height (cm) * 156 ( )157 ( )0.565 Body weight (Kg) * 59 (46-74)60 (49-76)0.544 Operation time (mins) ** LAVH (n=25)91.8± ± TAH (n=25)122.1± ± Hospital stay (days) ** LAVH (n=25)2.5±0.92.5± TAH (n=25)5.1±0.74.6± Acute Complications 0/25 Late Complications 0/251/25 † Table 2. Satisfaction of handling performance in using Monosyn ® and Vicryl plus ® Scores for each factors assessed by the surgeons. Excellent : 4 Satisfying : 3 Sufficient : 2 Poor : 1 * mean±standard deviation ** Mann-Whitney test We observed the knot security, knot breaking load, and placing property of the sutures during operation and evaluated with the 4 levels of score. We also evaluated and comparatively analyzed the wound recovery state and cosmetic condition, including infection, swelling or dehiscence of the suture site, when visiting the hospital 4 weeks after discharge There was no significant demographic difference in age, height, and weight between the Monosyn group and Vicryl Plus group. In addition, no significant difference was found in the operation time and hospitalization duration by operation method between the two suture groups. As for the knot security and placing property during operation, there was no significant difference found between the two groups. In the knot breaking load, the satisfaction for the Monosyn group was significantly high in both aspects of knot running and knot tensile strength (p<0.05). In the evaluation of handling in general, the satisfaction for the Vicryl Plus group was significantly high (p<0.05). In the evaluation 4 weeks after discharge, there was no difference found in the inflammation, secretion and color change between the two groups, while the edematous change was significantly high in the Vicryl Plus group (p<0.05). As for the cosmetic aspect of the operation wound recovery condition, the satisfaction for the Monosyn group was significantly high (p<0.05 ) Table 3. Postpoperative wound assessment of Monosyn ® and Vicryl plus ® Monosyn® group * (n=25) Vicryl Plus ® Group * (n=25) p value ** Inflammation3.7±0.63.7± Edema3.7±0.53.4±0.6<0.05 Secretion3.2±0.43.1± Color change3.8±0.43.6± Dehiscence0/251/25 † Cosmetic situation 3.4±0.63.0±0.7<0.05 Postoperative wound assessment during Inflammation / Edema / Secreti on / Color change according to the presence of None (4 points)-Mild (3 p oints)-Moderate (2points)-Severe (1) points are evaluated. Cosmetic situation, the Excellent (4 stars)-Satisfying (3 points)-Sufficient (2 points)-Poor (1 point) and should be evaluated by the surgeon. * mean±standard deviation ** Mann-Whitney test † 1 case of vaginal stump dehiscence Figure 1. Monosyn® and Vicryl Plus®
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