Evaluation of a Monofile, Ultra-Long Absorbable Suture with High Elasticity for Abdominal Wall Closure Under Daily Clinical Routine MULTIMAC a Prospective Observational Study
Journal of Surgery
Volume 7, Issue 1, February 2019, Pages: 1-7
Received: Oct. 29, 2018;
Accepted: Jan. 20, 2019;
Published: Feb. 19, 2019
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Petra Baumann, Department of Medical Scientific Affairs, Aesculap AG, Tuttlingen, Germany
Florin Savulescu, Department of Surgery; Central Emergency Military Hospital, Bucharest, Romania
Alexander Ferko, Department of Surgery; University Hospital Hradec Králové, Hradec Kralove, Czech Republic
Cestmir Neoral, Department of Surgery; University Hospital Olomouc, Olomouc, Czech Republ
Moritz Nicolas Wente, Department of Medical Scientific Affairs, Aesculap AG, Tuttlingen, Germany
Recent meta-analyses have shown that the application of a monofile, late-absorbable suture using a continuous suture technique with a suture-to-wound length ratio of at least 4:1 is the method of choice for the closure of midline laparotomies. Monomax, a new ultra-long term absorbable, high elastic monofilament suture, was approved in 2009 and its safety and efficacy were proven in a selected patient population under controlled conditions for elective midline abdominal wall closure (ISSAAC Study). The present multi-centric, international, prospective observational study is aimed at evaluating the performance of Monomax suture for transverse and midline abdominal wall closure in daily clinical practice even in high risk patients. A total of 200 patients undergoing a primary elective laparotomy using either a midline or transverse incision were examined regarding the frequency of short-term complications (e.g. reoperation due to burst abdomen, wound infection, wound healing disorders), until discharge and 1 month after surgery. Postoperative length of hospital stay was also reported. Frequency of reoperation due to burst abdomen was 2.5% and a wound infection rate of 3.5% was reported up to day of discharge. Seven patients developed a wound healing disorder (3.5%). Average length of postoperative hospital stay was 10.3 days. Our results indicate that the ultra-long term absorbable, elastic monofilament suture is safe and efficient for transverse and midline abdominal wall closure performed under daily clinical routine even in high risk patients.
Moritz Nicolas Wente,
Evaluation of a Monofile, Ultra-Long Absorbable Suture with High Elasticity for Abdominal Wall Closure Under Daily Clinical Routine MULTIMAC a Prospective Observational Study, Journal of Surgery.
Vol. 7, No. 1,
2019, pp. 1-7.
Seiler CM, Deckert A, Diener MK, Knaebel HP, Weigand MA, Victor N, Büchler MW. Midline versus transverse incision in major abdominal surgery: a randomized, double-blind equivalence trial (POVATI: ISRCTN60734227). Ann Surg. 2009 Jun; 249 (6):913-20.
Van`t Riet M, Steyerberg EW, Nellensteyn J, Bonjer HJ, Jeekel J: Meta-analysis of techniques for closure of midline abdominal incisions. Br J Surg. 2002; 89 (11):1350-1356.
Weiland DE, Bay RC, Del Sordi S: Choosing the best abdominal closure by meta-analysis. Am J Surg. 1998; 176 (6): 666-670.
Hodgson NC, Malthaner RA, Ostbye T: The search for an ideal method of abdominal fascia closure: a meta-analysis. Ann Surg. 2000; 231 (3):436-442.
Rucinski J, Margolis M, Panagopoulos G, Wise L: Closure of the abdominal midline fascia: meta-analysis delineates the optimal technique. Am Surg. 2001; 67:421-426.
Hsiao WC, Young KC, Wang ST, Lin PW: Incisional hernia after laparotomy: prospective randomized comparison between early-absorbable and late-absorbable suture materials. World J Surg. 2000; 24 (6):747-751.
Seiler CM, Bruckner T, Diener MK, Papyan A, Golcher H, Seidlmayer C, Franck A, Kieser M, Büchler MW, Knaebel HP. Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicenter randomized trial (INSECT: ISRCTN24023541). Ann Surg.2009; 249:576-82.
Diener MK, Voss S, Jensen K, Büchler MW, Seiler CM. Elective midline laparotomy closure: the INLINE systematic review and meta-analysis. Ann Surg. 2010 May; 251 (5):843-56.
Muysoms FE, Antoniou SA, Bury K, Campanelli G, Conze J, Cuccurullo D, de Beaux AC, Deerenberg EB, East B, Fortelny RH, Gillion JF, Henriksen NA, Israelsson L, Jairam A, Jänes A, Jeekel J, López-Cano M, Miserez M, Morales-Conde S, Sanders DL, Simons MP, Śmietański M, Venclauskas L, Berrevoet F; European Hernia Society. European Hernia Society guidelines on the closure of abdominal wall incisions. Hernia. 2015 Feb; 19 (1):1-24.
Odermatt EK, Funk L, Bargon R, Martin DP, Rizk S, Williams SF, “MonoMax Suture: A New Long-Term Absorbable Monofilament Suture Made from Poly-4-Hydroxybutyrate. Int J Polymer Science,2012; 2012:1-12.
Fischer L, Baumann P, Hüsing J, Seidlmayer C, Albertsmeier M, Franck A, Luntz S, Seiler CM, Knaebel HP. A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079]. BMC Surg. 2008 Jul; 8:12.
Albertsmeier M, Seiler CM, Fischer L, Baumann P, Hüsing J, Seidlmayer C, Franck A, Jauch KW, Knaebel HP, Büchler MW. Albertsmeier. Evaluation of the safety and efficacy of MonoMax® suture material for abdominal wall closure after primary midline laparotomy-a controlled prospective multicentre trial: ISSAAC [NCT005725079]. Langenbecks Arch Surg. 2012 Mar; 397 (3):363-71.
Agha RA, Borrelli MR, Vella-Baldacchino M, Thavayogan R, and Orgill DP for the STROCSS Group. The STROCSS Statement: Strengthening the Reporting of Cohort Studies in Surgery. Int J Surg. 2017 Sept; 46:198-202.
Miles JS: Use of polydioxanone absorbable monofilament sutures in orthopaedic surgery. Orthopedics 1986; 9:1533-1536.
Bickenbach KA, Karanicolas PJ, Ammori JB, Jayaraman S, Winter JM, Fields RC, Govindarajan A, Nir I, Rocha FG, Brennan MF. Up and down or side to side? A systematic review and meta-analysis examining the impact of incision on outcomes after abdominal surgery. Am J Surg. 2013 Sep; 206 (3):400-9.
Brown SR, Goodfellow PB. Transverse verses midline incisions for abdominal surgery. Cochrane Database Syst Rev. 2005 Oct;(4):CD005199.
Gurusamy KS, Cassar Delia E, Davidson BR. Peritoneal closure versus no peritoneal closure for patients undergoing non-obstetric abdominal operations. Cochrane Database Syst Rev. 2013 Jul;(7):CD010424.
Millbourn D, Cengiz Y, Israelsson LA. Risk factors for wound complications in midline abdominal incisions related to the size of stitches. Hernia. 2011 Jun; 15 (3):261-6.
Abo-Ryia MH, El-Khadrawy OH, Abd-Allah HS. Prophylactic preperitoneal mesh placement in open bariatric surgery: a guard against incisional hernia development. Obes Surg. 2013 Oct; 23 (10):1571-4.
Strzelczyk JM, Szymański D, Nowicki ME, Wilczyński W, Gaszynski T, Czupryniak L. Randomized clinical trial of postoperative hernia prophylaxis in open bariatric surgery. Br J Surg. 2006 Nov; 93 (11):1347-50.
Muysoms FE, Detry O, Vierendeels T, Huyghe M, Miserez M, Ruppert M, Tollens T, Defraigne JO, Berrevoet F. Prevention of Incisional Hernias by Prophylactic Mesh-augmented Reinforcement of Midline Laparotomies for Abdominal Aortic Aneurysm Treatment: A Randomized Controlled Trial. Ann Surg. 2016 Apr; 263 (4):638-45.
Bevis PM, Windhaber RA, Lear PA, Poskitt KR, Earnshaw JJ, Mitchell DC. Randomized clinical trial of mesh versus sutured wound closure after open
abdominal aortic aneurysm surgery. Br J Surg. 2010 Oct; 97 (10):1497-502. . Israelsson LA, Jonsson T. Suture length to wound length ratio and healing of midline laparotomy incisions. Br J Surg. 1993; 80:1284-6.
Millbourn D, Cengiz Y, Israelsson LA. Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg. 2009; 144:1056-9.
Deerenberg EB, Harlaar JJ, Steyerberg EW, Lont HE, van Doorn HC, Heisterkamp J, Wijnhoven BP, Schouten WR, Cense HA, Stockmann HB, Berends FJ, Dijkhuizen FP, Dwarkasing RS, Jairam AP, van Ramshorst GH, Kleinrensink GJ, Jeekel J, Lange JF. Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial. Lancet. 2015 Sep 26; 386 (10000): 1254-60.
Fortelny RH, Baumann P, Thasler WE, Albertsmeier M, Riedl S, Steurer W, Kewer JL, Shamiyeh A. Effect of suture technique on the occurrence of incisional hernia after elective midline abdominal wall closure: study protocol for a randomized controlled trial. Trials. 2015 Feb; 16: 52.