Top

Published in:

Open Access 01-03-2012 | Controlled Clinical Trial

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]

Authors: Markus Albertsmeier, Christoph M. Seiler, Lars Fischer, Petra Baumann, Johannes Hüsing, Christoph Seidlmayer, Annette Franck, Karl-Walter Jauch, Hanns-Peter Knaebel, Markus W. Büchler

Published in: Langenbeck's Archives of Surgery | Issue 3/2012

Abstract

Purpose

Different suture techniques and various suture materials are in use to close midline incisions after primary laparotomy. The ISSAAC study aimed to assess the safety and efficacy of the new ultra-long-term absorbable, elastic monofilament suture material MonoMax® for abdominal wall closure.

Methods

This is a single-arm, multicentre prospective study that included 150 patients undergoing a primary elective midline incision. The control group consists of 141 patients from the INSECT study who received MonoPlus® or PDS® for abdominal wall closure. The incidences of burst abdomen and wound infection until the day of discharge were defined as the primary composite endpoints. The rate of incisional hernias 1 year after surgery, the length of postoperative hospital stay and safety parameters served as secondary endpoints. The study has been registered under www.clinicaltrials.gov [NCT005725079].

Results

Eleven patients in the ISSAAC study [7.3%; 95% CI = (3.9; 13.1%)] experienced wound infection or burst abdomen until the day of discharge as compared to 16 [11.3%; 95% CI = (6.6; 17.8%)] patients in the INSECT control group (p = 0.31). The length of postoperative hospital stay was comparable in both study groups. One year after surgery, incisional hernias were observed in 21 ISSAAC patients (14.0%) in contrast to 30 hernias (21.3%) in the INSECT control group.

Conclusions

The ultra-long-term absorbable, elastic monofilament suture material MonoMax® is safe and efficient for abdominal wall closure.

Seiler CM, Bruckner T, Diener MK, Papyan A, Golcher H, Seidlmayer C, Franck A, Kieser M, Buchler MW, Knaebel HP (2009) Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicenter randomized trial (INSECT: ISRCTN24023541). Ann Surg 249(4):576–582PubMedCrossRef

Conze J, Klinge U, Schumpelick V (2005) Narbenhernien. Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen 76(9):897–909, quiz 910PubMedCrossRef

Sugerman HJ, Kellum JM Jr, Reines HD, DeMaria EJ, Newsome HH, Lowry JW (1996) Greater risk of incisional hernia with morbidly obese than steroid-dependent patients and low recurrence with prefascial polypropylene mesh. Am J Surg 171(1):80–84PubMedCrossRef

Mudge M, Hughes LE (1985) Incisional hernia: a 10 year prospective study of incidence and attitudes. Br J Surg 72(1):70–71PubMedCrossRef

Luijendijk RW, Lemmen MH, Hop WC, Wereldsma JC (1997) Incisional hernia recurrence following "vest-over-pants" or vertical Mayo repair of primary hernias of the midline. World J Surg 21(1):62–65, discussion 66PubMedCrossRef

Paul A, Lefering R, Kohler L, Eypasch E (1997) Current practice of incisional hernia reconstruction in Germany. Zentralblatt fur Chirurgie 122(10):859–861PubMed

Manninen MJ, Lavonius M, Perhoniemi VJ (1991) Results of incisional hernia repair. A retrospective study of 172 unselected hernioplasties. Eur J Surg 157(1):29–31PubMed

Hoer J, Lawong G, Klinge U, Schumpelick V (2002) [Factors influencing the development of incisional hernia. A retrospective study of 2,983 laparotomy patients over a period of 10 years]. Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen 73(5):474–480PubMedCrossRef

Israelsson LA, Jonsson T (1993) Suture length to wound length ratio and healing of midline laparotomy incisions. Br J Surg 80(10):1284–1286PubMedCrossRef

10.

Irvin TT, Stoddard CJ, Greaney MG, Duthie HL (1977) Abdominal wound healing: a prospective clinical study. Br Med J 2(6083):351–352PubMedCrossRef

11.

Gys T, Hubens A (1989) A prospective comparative clinical study between monofilament absorbable and non-absorbable sutures for abdominal wall closure. Acta Chir Belg 89(5):265–270PubMed

12.

Osther PJ, Gjode P, Mortensen BB, Mortensen PB, Bartholin J, Gottrup F (1995) Randomized comparison of polyglycolic acid and polyglyconate sutures for abdominal fascial closure after laparotomy in patients with suspected impaired wound healing. Br J Surg 82(8):1080–1082PubMedCrossRef

13.

van’t Riet M, Steyerberg EW, Nellensteyn J, Bonjer HJ, Jeekel J (2002) Meta-analysis of techniques for closure of midline abdominal incisions. Br J Surg 89(11):1350–1356CrossRef

14.

Weiland DE, Bay RC, Del Sordi S (1998) Choosing the best abdominal closure by meta-analysis. Am J Surg 176(6):666–670PubMedCrossRef

15.

Hodgson NC, Malthaner RA, Ostbye T (2000) The search for an ideal method of abdominal fascial closure: a meta-analysis. Ann Surg 231(3):436–442PubMedCrossRef

16.

Rucinski J, Margolis M, Panagopoulos G, Wise L (2001) Closure of the abdominal midline fascia: meta-analysis delineates the optimal technique. Am Surg 67(5):421–426PubMed

17.

Wissing J, van Vroonhoven TJ, Schattenkerk ME, Veen HF, Ponsen RJ, Jeekel J (1987) Fascia closure after midline laparotomy: results of a randomized trial. Br J Surg 74(8):738–741PubMedCrossRef

18.

Knaebel H-P, Koch M, Sauerland S, Diener MK, Büchler MW, Seiler CM (2005) Interrupted or continuous slowly absorbable sutures—design of a multi-centre randomised trial to evaluate abdominal closure techniques INSECT-Trial [ISRCTN24023541]. BMC Surg 5:3PubMedCrossRef

19.

Hsiao WC, Young KC, Wang ST, Lin PW (2000) Incisional hernia after laparotomy: prospective randomized comparison between early-absorbable and late-absorbable suture materials. World J Surg 24(6):747–751, discussion 752PubMedCrossRef

20.

Diener MK, Voss S, Jensen K, Buchler MW, Seiler CM (2010) Elective midline laparotomy closure: the INLINE systematic review and meta-analysis. Ann Surg 251(5):843–856PubMedCrossRef

21.

Miles JS (1986) Use of polydioxanone absorbable monofilament sutures in orthopedic surgery. Orthopedics 9(11):1533–1536PubMed

22.

Choi H-J, Chae H-D (2009) Comparison of E. coli infiltration between new synthetic absorbable sutures. J Korean Surg Soc 77(1):1–6CrossRef

23.

Fackeldey V, Hoer J, Klinge U (2004) [Fascial healing and wound failure]. Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen 75(5):477–483PubMedCrossRef

24.

Fischer L, Baumann P, Husing J, Seidlmayer C, Albertsmeier M, Franck A, Luntz S, Seiler CM, Knaebel HP (2008) A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax(R) suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079]. BMC Surg 8(1):12PubMedCrossRef

25.

Clopper CJ, Pearson ES (1934) The use of confidence or fiducial limits illustrated in the case of the binomial. vol 26. First published. doi:10.1093/biomet/26.4.404

26.

Hoer J, Klinge U, Schachtrupp A, Tons C, Schumpelick V (2001) Influence of suture technique on laparotomy wound healing: an experimental study in the rat. Langenbecks Arch Surg 386(3):218–223PubMedCrossRef

27.

Millbourn D, Cengiz Y, Israelsson LA (2009) Effect of stitch length on wound complications after closure of midline incisions: a randomized controlled trial. Arch Surg 144(11):1056–1059PubMedCrossRef

28.

Pollock AV, Evans M (1989) Early prediction of late incisional hernias. Br J Surg 76(9):953–954PubMedCrossRef

Title: 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]
Authors: Markus Albertsmeier
Christoph M. Seiler
Lars Fischer
Petra Baumann
Johannes Hüsing
Christoph Seidlmayer
Annette Franck
Karl-Walter Jauch
Hanns-Peter Knaebel
Markus W. Büchler
Publication date: 01-03-2012
Publisher: Springer-Verlag
Published in: Langenbeck's Archives of Surgery / Issue 3/2012
Print ISSN: 1435-2443
Electronic ISSN: 1435-2451
DOI: https://doi.org/10.1007/s00423-011-0884-6

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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]

Abstract

Purpose

Methods

Results

Conclusions

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 3/2012

Status of robotic assistance—a less traumatic and more accurate minimally invasive surgery?

High-dose immunoglobulin preparations improve survival in a CLP-induced rat model of sepsis

Extracorporeal tourniquet method for intermittent hepatic pedicle clamping during laparoscopic liver surgery: an easy, cheap, and effective technique

Polysaccharide-K (PSK) may suppress surgical stress-induced metastasis in rat colon cancer

State of the art: surgery for endemic goiter

Laparoscopic assisted sigmoid resection for diverticular disease