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      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]

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          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.

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          Most cited references25

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          [Factors influencing the development of incisional hernia. A retrospective study of 2,983 laparotomy patients over a period of 10 years].

          V. Schumpelick, J Höer, G Lawong … (2002)
          Incisional hernia formation is one of the most frequent complications in visceral surgery requiring reoperation. Risk factors for incisional hernia formation and preventive strategies are not clearly defined. In a retrospective study including 2983 patients over a 10-year period, the influence of demographic data, pre-, intra- and postoperative risk factors for incisional hernia development were evaluated. From the subgroups medical history, medication, laboratory values, indication, surgical technique, course of operation, postoperative course and wound healing, altogether 43 parameters were analysed. Statistical evaluation was performed using the chi 2-test according to Pearson, and binary logistic regression analysis. The mean incisional hernia incidence in the study was 4.3%. In the mean follow-up period of 21.1 months, the incisional hernia incidence was calculated at 9.8% using the Kaplan-Meier estimate; for a 10-year period it reached 18.7%. The study revealed that 31.5% of all incisional hernias developed in the first 6 months after the operation, 54.4% after 12 months, 74.8% after 2 years and 88.9% after 5 years. Significant demographic factors influencing incisional hernia incidence were age (> 45 years) and male gender. The preoperative factors anaemia (Hb 25, the intraoperative factors recurrent incision and previous laparotomy, and the postoperative factors catecholamin-therapy and disturbed wound healing were of significant influence. The calculated incisional hernia incidence for a 10 year period of almost 20% and the manifestation of 50% of all hernias more than 12 months after the operation, underline the necessity to intensify surgical research in the field of laparotomy healing. In comparison to demographic and endogenous risk factors, the surgical technique has less influence on laparotomy healing. Measures to ameliorate tissue perfusin seem to exert a positive influence on incisional hernia incidence.
          Article 0 comments Cited 89 times – based on 0 reviews     Review now
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            Elective midline laparotomy closure: the INLINE systematic review and meta-analysis.

            Sabine Voss, C Seiler, Markus W. Büchler … (2010)
            To evaluate the optimal technique and material for abdominal fascia closure after midline laparotomy, first by means of a precisely defined study population and follow-up period and second by the surgically driven aspects. Overview of existing systematic reviews and meta-analysis of randomized controlled trials. A systematic literature search (Medline, Embase, and The Cochrane Central Register of Controlled Trials) was performed to identify randomized controlled trials in elective and emergency populations comparing suture techniques (continuous vs. interrupted) and materials (rapidly vs. slowly vs. nonabsorbable). Random effects conventional and cumulative meta-analyses were calculated and presented as odds ratios and the corresponding 95% confidence intervals. Five systematic reviews and 14 trials including 7711 patients (6752 midline incisions) were analyzed. None of the systematic reviews differentiated elective versus emergency laparotomy. The analysis of available primary studies revealed significant lower hernia rates using a continuous (vs. interrupted) technique (OR: 0.59; P=0.001) with slowly absorbable (vs. rapid-absorbable) suture material (OR: 0.65; P=0.009) in the elective setting, which was in contrast to the conflicting results of existing systematic reviews. No statistical heterogeneity was detected in the elective setting (I=0%). Seven studies incorporating elective and emergency procedures revealed inconclusive and heterogeneous results (I=45%-85%). No studies have evaluated closure methods solely in the emergency setting so far. No further trials should be conducted for evaluation of technique and available materials for elective midline abdominal fascial closure, according to the results of our cumulative meta-analysis. Future trials will have to define the optimal closure strategy in the emergency setting and relevance of new suture materials and other strategies such as the use of prophylactic mesh in targeted subpopulations.
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              Incisional hernia: a 10 year prospective study of incidence and attitudes.

              Peter Hughes, Jonathan Mudge (1984)
              Five hundred and sixty-four patients reviewed 1 year after major abdominal surgery have been studied prospectively by a single observer for 10 years to determine the incidence and significance of incisional hernia. Of 337 (60 per cent) patients completing the 10 year follow-up 37 (11 per cent) developed an incisional hernia and 13 (35 per cent) of these first appeared at 5 years or later. One in three hernias caused symptoms. The late appearing hernias were smaller than the early ones, and caused little trouble. Of the 18 patients who consulted their general practitioner, 11 had symptoms and of these six (55 per cent) were referred for surgical opinion. Many hernias were diagnosed at routine outpatient follow-up and were likely to receive treatment from the surgeon. Most symptomatic patients were offered surgery with the remainder usually being offered a corset. In about half our patients (mainly those without symptoms) surgery was refused or advised against although the patients would have accepted it. Recurrence is common after surgical repair (40 per cent) but seems to be related to surgical technique. The possibility of complications occurring from an incisional hernia does not appear to be discussed with patients although obstruction occurred in 14 per cent of our patients with troublesome hernia.
              Article 0 comments Cited 69 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                : +49-89-70952790 , +49-89-7095-8893 , Karl-Walter.Jauch@med.uni-muenchen.de
                Journal
                Journal ID (nlm-ta): Langenbecks Arch Surg
                Title: Langenbeck's Archives of Surgery
                Publisher: Springer-Verlag (Berlin/Heidelberg )
                ISSN (Print): 1435-2443
                ISSN (Electronic): 1435-2451
                Publication date (Electronic): 20 December 2011
                Publication date PMC-release: 20 December 2011
                Publication date (Print): March 2012
                Volume: 397
                Issue: 3
                Pages: 363-371
                Affiliations
                [1 ]Department of Surgery, University of Munich, Grosshadern Campus, Marchioninistr. 15, 81377 München, Germany
                [2 ]Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Heidelberg, Germany
                [3 ]Department of Medical Scientific Affairs, Aesculap AG, Tuttlingen, Germany
                [4 ]Coordination Centre for Clinical Trials (KKS), University of Heidelberg, Heidelberg, Germany
                [5 ]Department of Visceral Surgery, St. Bonifatius Hospital, Lingen, Germany
                [6 ]Department of Visceral, Thoracic and Vascular Surgery, Philipps University Marburg, Marburg, Germany
                Article
                Publisher ID: 884
                DOI: 10.1007/s00423-011-0884-6
                PMC ID: 3281202
                PubMed ID: 22183105
                SO-VID: 223a0773-a673-4415-ac60-ec59edb46273
                Copyright © © Springer-Verlag 2011
                History
                Date received : 4 September 2011
                Date accepted : 21 November 2011
                Categories
                Subject: Controlled Clinical Trial
                Custom metadata
                issue-copyright-statement © Springer-Verlag 2012

                ScienceOpen disciplines: Surgery
                Keywords: fascia,humans,laparotomy,abdominal hernia,suture materials
                Data availability:
                ScienceOpen disciplines: Surgery
                Keywords: fascia, humans, laparotomy, abdominal hernia, suture materials

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