Clinical Usefulness and Safety of the Anti-bacterial coated multifilament suture

1. Clinical Usefulness and Safety of the Anti-bacterial coated multifilament suture (VicrylPlus®) and Monofilament Suture (Monosyn®) in Hysterectomy Shin-WhaLee, Hye-Sung Won, Yong-Man Kim, AhmKimDepartment of Obstetrics and Gynecology, College of Medicine, University of Ulsan, Asan Medical Center, Seoul, Korea. OPTIONALLOGO HERE OPTIONALLOGO HERE Figure 1. Monosyn® and Vicryl Plus® Objectives 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 ) Results 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. 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). Methods 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 Monosynhad 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. 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 Table 1. Chracteristics of Monosyn® Group and VicrylPlus® Group in case of hysterectomy Table 3. Postpoperative wound assessment of Monosyn ® and Vicryl plus ® References • 1. Ray JA, Doddi N, Regula D, Williams JA, Melveger A, Polydioxanone (PDS), a novel monofilament synthetic absorbable suture. SurgGynecolObstet 1981;153:497-507. • 2. Bezwada RS, Jamiokowski DD, Lee IY, Agarwal V, Persivale J, Trenka-Benthin S, Emeta M, Suryadevara J, Yang A, Liu S. Monocryl suture, a new ultra-pliable absorbable monofilament suture. Biomaterials 1995;16:1141-1148. • 3. RodeheaverGT, Beltran KA, Green CW, Faulkner BC, Stiles BM, Stanimir GW, Traeland H, Fried GM, Brown HC, Edlich RF. Biomechanical and clinical performance of a new synthetic monofilament absorbable suture. J Long Term Eff Med Implants 1996;6:181-198. • 4. LaufmanH, Rubel T. Synthetic absorbable sutures. SurgGynecolObstet 1977;145:597-608. • 5. OlahA, Belagyi T, Neuberger G, Gamal EM. Use of different absorbable sutures for continuous single-layer anastomosis in the gastrointestinal tract. A prospective, randomized study. Dig Surg 2000;17:483-485. • 6. Rout WR. Gastrointestinal suturing. In: Zuidema GD. Shackelford’s Surgery of the Alimentary Tract. 4th ed. Philadelphia: WB Saunders, 1996;348-363. • 7. Katz AR, Mukherjee DP, Kaganov AL, Gordon S. A new synthetic monofilament absorbable suture made from polytrimethylene carbonate. SurgGynecolObstet 1985;161:213-222. Table 2. Satisfaction of handling performance in using Monosyn ® and Vicryl plus ® Postoperative wound assessment during Inflammation / Edema / Secretion / Color change according to the presence of None (4 points)-Mild (3 points)-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 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 Scores for each factors assessed by the surgeons. Excellent : 4 Satisfying : 3 Sufficient : 2 Poor : 1 *mean±standard deviation ** Mann-Whitney test