The Journal of The Textile Institute Vol. 100, No.

1, January 2009, 51-56

I Taylor & Francis

Taylor&FranciiCroup

Measuring the strength of knotted suture materials

D.J. Carr^*, A.G. Heward^ R.M. Laing" and B.E. Niven''
"Department of Clothing and Textile Sciences, University ofOtago, Dunedin, New Zealand; ''Centre for Applications of Statistics and Mathematics, University of Otago, Dunedin, New Zealand {Received 27 September 2006; final version received 26 Juiy 2007} There is no international standard method for measuring the strength of knotted suture materials, and although several methods have been published, there has been minimal investigation on the effects of test variables on measured properties (e.g. speed, gauge length, and knot tensioning force). Methods investigated in this work were the "ear method" (with and without a rod inside the loop), and the "cut-loop and ear method". The test environment, material, and type of knot were constant. Effects of varying gauge length, test speed, and knot-tensioning force on tenacity and strain were investigated and compared with data for nonknotted sutures. Different values of tenacity and strain were evident for the different test methods; lower values of tenacity for specimens with shorter gauge lengths and tested at greater speeds; lower values of strain for specimens with longer gauge lengths and tested at greater speeds. Thus, tensile properties of suture materials tested at one gauge length or one test speed, as widely reported in the literature, may be misleading. Knot tensioning force neither affect tenacity nor strain. Keywords: tenacity; strain; gauge length; test speed

Introduction Suturing involves use of a (usually) polytneric material (monofilament or multifilament) to pull wound edges together. The two ends (ears) of the suture material are typically knotted to maintain suture security. The knot itself is composed of a number of throws that involve wrapping two strands so that the angle of the wrap is 360 (Batra et al., 1992). The suture holds the wound edges together until healing has progressed sufficiently and the tissue is strong enough to withstand normal tensile forces. Scars stretch less and arefinerif the dermal layer is supported long enough for collagen in the scar to mature (Thomson, 1991). That the knot reduces the strength of the suture material, is widely recognized (e.g. Annunziata, Drake, Woods, Gear, Rodeheaver, & Edlich, 1997; Brouwers, Oosting, de Haas, & Klopper, 1991; Herrmann, Kelly, & Higgins, 1970), and surgeons often address this by adding extra throws which reportedly increase knot security, but of course does change the structure of the knot. Suture failure (i.e. the wound edges are no longer held together) occurs by knot slippage (i.e. the loop pulls through) or breakage (primarily at the knot) (Tera & Aberg, 1976b; van Rijssel, Brand, Admiraal, Smit, & Trimbos, 1989). Tightening the knot, friction between strands within a knot, and elongation of the suture material all contribute to the strength of a knotted suture loop when tension is applied (Herrmann, 1971 ; Huber, Eg-

ger, & James, 1999; Rosin & Robinson, 1989; Thacker et al., 1975). Although the tensile strength of a knotted suture material is a commonly used selection criterion, there is no international standard test method for measuring this. Several different methods are described in the literature and are widely used (e.g. "ear", "loop", "cut-loop", and "cut-loop and ear"). The test variables (e.g. environmental conditions, material, knot-type, knottensioning load, gauge length, and test speed) differ in various published studies, making comparisons among different suture materials and among different methods difticult. There is a need to understand how the different methods and variables affect the tensile properties measured. The ear method involves knotting a suture material around a tube or rod, the specimen is removed from the tube and one ear is inserted into each jaw of a tensile tester (Annunziata et al., 1997; Brouwers et al., 1991; Herrmann et al., 1970). Alternatively, the suture is knotted around a tube or rod that remains in the loop during the test (Rosin & Robinson, 1989). The clinical relevance of the ear technique has been questioned as the loop can pull through and the load is applied to the physician's side and not the patient's side of the knot (Huber et al., 1999; Thacker et al., 1975). In the loop technique, a suture is knotted around a tube. The loop thus formed is removed and positioned around

'Corresponding author. Email: d.carr@otago.ac.nz

ISSN 0040-5000 print/ISSN 1754-2340 online Copyright 2009 The Textile Institute DOI: 10.1080/00405000701608177 http://www.informaworld.com

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D.1 Carr et al. knot-tensioning load or force is reported in few investigations reviewed (e.g. 1.5 kg [Rosin & Robinson, 1989], 1 N [Schiller et al., 1993], 7 N [Nilsson, 1982], and 9 N [Holmlund, 1974]). Results from a trial involving 10 surgeons tying sutures around synthetic tissue did not include values for the knot-tensioning loads, but in the subsequent investigation knots were tensioned with a force of 10 N (Annunziata et al., 1997). The application of a (preload) force (7 N) to remove initial slack in the suture and to provide a zeroed reference point was discussed only in one study (Nilsson, 1982). The aims of this work were to (/) investigate the effect of selected test variables and (//) evaluate different test methods.

two right-angled rods that are placed in the jaws of a tensile tester (Annunziata et al., 1997; Bayraktar & Hockenberger 2001 Herrmann, 1971;Holmlund, 1974;Huberetal., 1999; Mishra, Cannon, Lucas, & Beizer, 1997; Nilsson, 1982; van Rijssel et al, 1989). While the load is applied to the patient's side, failure ofthe suture is usually by knot slippage, rather than knot failure. The tensile strength and strain measured may be affected by the length ofthe ears as they pull through the knot. In the cut-loop method a loop is formed as in the loop method, however the knotted suture loop is cut opposite the knot and each newly formed end is placed in a jaw of a tensile tester (Huber et al., 1999; Lewis, Milthorpe, & Bellenger, 1997; Rodeheaver, Green, Odum, Bussard, & Edlich, 1998; Rosin & Robinson, 1989; Schiller, Stone, & Gupta, 1993; Tera & Aberg, 1976a; Thacker et al., 1975). Although the load is applied to the patient's side, the cutloop technique usually measures knot slippage rather than knot strength, the measured values being affected by the length of the ears. The cut-loop and ear technique involves forming a loop and cutting it opposite the knot (Zimmer et al., 1991). One end of the cut loop and one ear are placed in each jaw of the tensile tester. Neither the ears nor the cut-loop ends can pull through the knot, therefore the strength of the knot is measured, although care must be taken when comparing results from this method to tests from those that mount only one strand of material in each jaw. That the gauge length and speed at which textile fibers (and yams) are tested affects the measured tenacity and strain is widely recognized (e.g. Hall, 1968; Morton & Hearle, 1993; Smith, Shouse, Blandford, & Towne, 1961). However, in most investigations involving knotted sutures, the tensile properties (usually strength) are reported at only one gauge length (e.g. 8 mm loop (Nilsson, 1982), 36 mm (Rosin & Robinson, 1989), 38 mm (Tera & Aberg, 1976a), 50 mm (Magilligan & DeWeese, 1974), 80 mm (Annunziata et al., 1997), and one test speed (e.g. 6 tntn/min [Gerber, Schneeberger, Beck, & Schlegel, 1994], 10 mm/min [Herrmann, 1971], 20 mm/min [Huber et al., 1999], 50 mm/min [Rodeheaver et al., 1998], 60 mm/min [Tera & Aberg, 1976a], and 75 mm/min [Nilsson, 1982]). Previous research involving knotted sutures has concentrated on identifying tensile properties of specimens prepared using different knots. Different descriptive terms for the tensioning force applied after tying the knot have been used for example, "snugged down" (Rodeheaver et al, 1998); "snugged down with maximum hand force" (Bayraktar & Hockenberger, 2001b); "tightened to appropriate wound" (Trimbos, Niggebrugge, Trimbos, & van Rijssel, 1995); "pulled tight slowly" (Jones & Weinberg, 2000); and "secure but not to strangulate the tissue" (Orr et al., 1990). In a laboratory investigation, using a measured load or force to ensure a uniform tension in suture knots is more appropriate. A

Experiment The material (monofilament, polyamide, and not sterile), knot (surgeon's square i.e. double wrap followed by a single throw), test environment (20 2C and 65% 4% relative humidity [RH]) (International Organization for Standardization, 1992), and preload (0.82 g) were constant thus reducing the number of variables that might affect the tensile properties measured. The effect of additional throws to the knot construction was not investigated, as the cumulative effect of tensioning the knot by extra throws would introduce yet another variable. The experiments were designed to address the following (/) effects of gauge length and test speed on the tensile properties measured using a range of test methods described in the literature, (//) effects of different test methods on the measured tensile properties, {m) effects of varying knot tensioning load on the measured tensile properties (Table 1). Experiments 1-3 investigated methods using specimens with a single strand of material being located in each jaw ofthe tensile tester, even though experiments 45 investigated specimens with double strands in each jaw. A bench-mounted Instron tensile tester model 4464 fitted with a 100 N load cell was used with flat-faced screwaction jaws that were mechanically tightened. Randomization of the sequence of tests within each test method ensured that results were not affected by investigator experience or minor fiuctuations in the environment. Load and extension data were collected using a PowerLab /16SP data acquisition system and Chart for Windows Version 3.4 (ADInstruments Ltd.) at a rate of one hundred data points per second (unfiltered). All tests were monitored for jaw slippage. Tenacity and strain at break were calculated. Descriptive statistics (mean, standard deviation, and coefficient of variation) were calculated for tenacity and strain (Statistical Package for Social Sciences version 10.3.1, SPSS) (SPSS Inc, 1995). Comparisons among test methods, test variables, specimen type, and knot-tensioning load were made. Differences in tenacity and strain were

The Journal of The Textile Institute Table 1. Tenacity and strain for nonknotted and knotted (surgeon's square) polyamide sutures. Test method Gauge length (mm) Test speed (mm/min) Tenacity (N/tex) Mean SD CV ,% Mean Strain at break SD CV,%

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Experiment 1 Nonknotted {n = 45) K.TF = 0

Experiment 2 Ear with rod {n = 45) KTF = 8 mN

Experiment 3 Ear no rod {n = 45) KTF = 8 mN

50 50 50 250 250 250 500 500 500 50 50 50 250 250 250 500 500 500 50 50 50 250 250 250 500 500 500 50 50 50 250 250 250 500 500 500 50 50 50 250 250 250 500 500 500

250 500 1000 250 500 1000 250 500 1000 250 500 1000

Experiment 4 Cut loop and ear (n = 27) KTF = 8 mN

Experiment 5 Cut loop and ear ( = 27) KTF = 0.6 N

Single strand of suture material 0.582 0.010 0.564 0.009 0.004 0.542 0.601 0.009 0.007 0.593 0.583 0.012 0.004 0.588 0.594 0.003 0.590 0.009 0.056 0.540 0.454 0.069 0.014 0.350 0.487 0.058 250 0.071 0.527 500 0.095 0.477 1000 0.050 250 0.529 0.546 0.035 500 0.522 0.026 1000 0.037 0.422 250 0.096 0.265 500 0.052 0.282 1000 0.454 0.099 250 0.419 0.163 500 0.098 0.275 1000 0.086 250 0.477 0.423 0.068 500 0.282 0.106 1000 strand of suture material Double s 0.867 0.020 250 0.733 0.104 500 1000 0.711 0.009 1.078 0.013 250 0.907 0.017 500 0.036 1000 0.838 0.041 1.054 250 0.028 1.065 500 0.020 0.901 1000 0.847 0.016 250 500 0.768 0.004 0.709 0.015 1000 0.036 1.026 250 0.887 0.006 500 0.812 0.006 1000 0.013 250 1.070 0.023 500 1.039 0.012 0.872 1000

1.66 1.66 0.74 1.43 1.21 2.01 0.61 0.58 1.58 10.27 15.29 4.01 11.99 13.48 19.92 9.44 6.33 5.00 8.73 36.20 18.52 21.91 38.90 35.79 18.09 16.01 37.66 2.36 14.20 1.25 1.24 1.85 4.26 3.89 2.58 2.26 1.86 0.56 2.15 3.52 0.72 0.78 1.18 2.18 1.35

0.471 0.497 0.469 0.334 0.334 0.335 0.298 0.307 0.304 0.505 0.424 0.317 0.237 0.280 0.254 0.248 0.258 0.234 0.796 0.598 0.647 0.251 0.309 0.205 0.252 0.205 0.163 0.295 0.255 0.242 0.278 0.195 0.183 0.241 0.252 0.176 0.299 0.283 0.264 0.250 0.191 0.177 0.255 0.237 0.170

0.032 0.016 0.042 0.016 0.009 0.015 0.005 0.008 0.013 0.092 0.100 0.034 0.051 0.059 0.083 0.046 0.039 0.027 0.033 0.173 0.117 0.092 0.131 0.063 0.056 0.060 0.045 0.031 0.028 0.007 0.016 0.010 0.010 0.022 0.021 0.006 0.016 0.005 0.019 0.024 0.006 0.004 0.010 0.012 0.005

6.84 3.14 8.86 4.86 2.74 4.53 1.58 2.68 4.15 18.21 23.50 10.84 21.62 21.12 32.49 18.60 15.16 11.55 4.21 28.93 18.06 36.59 42.21 30.81 22.15 29.31 27.33 10.47 10.91 3.01 5.76 4.90 5.51 8.97 8.24 3.48 5.44 1.65 7.10 9.49 3.09 2.21 3.78 4.95 3.19

KTF = knot tensioning force; CV = variability.

identified by analysis of variance. Assumptions of homogeneity of variance and normality of the residuals were confirmed. Only main experimental variables are reported as these are the focus of this work, and the effects of significant interactions were small. Tukey's multiple comparison tests were used to identify where differences among means occurred at 5% level of significance (Tukey, 1977).

Results and discussion Summary statistics for tenacity and strain at break data from experiments 1-5 are given in Table 1. Specimen failure rate at the knot was high, that is, experiment 2 = 94%, experiment 3 = 98%, experiment 4 = 100%, and experiment 5 = 100%. The magnitude and variability of tenacity and strain data obtained for nonknotted specimens were

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D.J Carr et al. a 50 mm gauge length (0.27). Strain was lower at higher test speeds (250 mm/min = = 0.27; 500 mm = 0.23; 1000 mm/min = 0.20). Four points warrant discussion: (1) Eect of knot: the tenacity and strain of knotted specimens were lower than nonknotted specimens irrespective of gauge length or test speed. The failure of the specimen, the knot, indicates an area of high stress concentration, it seems likely that the polyamide material in the knot region is weakened during knot construction. These observations are consistent with other published findings (Magilligan & DeWeese, 1974), although the effects of gauge length and test speed for knotted specimens do not appear to have been previously reported. (2) Effect of knot-tensioning force: increasing the knottensioning force from 8 mN to 0.6 N (experiments 4 and 5) did not affect tenacity or strain across a range of gauge lengths and test speeds in the present study, although knotting technique has been reported previously as affecting the properties of suture materials (Huber et al., 1999; Tera & Aberg, 1976a). Further, varying the knot tensioning force did not affect the location of failure. (3) Test methods: tenacity and strain data obtained using the cut-loop and ear method cannot be compared directly with other methods assessed in this work as the specimens consisted of two suture strands. However, it should be noted that knot slippage did not occur in the cut-loop and ear method. The ear method without a rod resulted in the loop pulling through the knot under the applied force resulting in a higher measured strain compared with the ear with rod method (loop not pulled through). Tenacity measured using the ear without rod method was lower than that measured using the ear with rod method. It may be that the polyamide material was damaged as it was pulled through the knot in the ear without rod tests. The application of different test methods with one material highlights variables that might be pertinent, and thus the difficulties in comparing results from different studies when these have not been standardized. The variability of properties for knotted specimens measured using the cut-loop and ear method with a knot tensioning force was most similar to the variability obtained for the nonknotted material, suggesting this test method yields results which are the most consistent. (4) Gauge length and test speed: that knotted suture material behaved differently under different test, conditions was evident from the present study, with lower values of strain observed for longer gauge lengths and at greater test speeds for nonknotted and knotted specimens. These results were as expected and similar trends have been reported for nonknotted polyamide monofilament and multifilament specimens (Hall, 1968; Meredith,

comparable with published values for polyamide (Mclntyre, 2005; Morton & Hearle, 1993). The variability (CV%) in results for knotted specimens obtained using the ear with or without rod methods (tenacity 4.01%-19.92%, 8.73%-37.66%; strain 10.84%-32.49%, 4.21%-42.21%) was greater for nonknotted than (tenacity 0.58%-2.01%; strain 1.58%-8.86%) cut-loop and ear method with 8 mN knot tensioning force (tenacity 1.24-14.20%, strain 3.0110.97%) and cut-loop and ear method with 0.6 N knot tensioning force (tenacity 0.56%-3.52%; strain 1.65%9.49%). A comparison of results from experiments 1-3 allowed for the effects of the following variables to be examined for nonknotted and knotted specimens(i) knot, (//) test method (ear with or with a rod), {Hi) gauge length, and (i'v) test speed. Lower mean values for tenacity and strain at break were measured for knotted single monofilaments (0.43 N/tex; 0.34) compared with nonknotted specimens (0.58 N/tex; 0.37) across all gauge lengths and test speeds (F2,io8 = 125.518, P < .001; F2.108 = 16.185, P < .001). The lowest tenacity was measured using the ear without a rod method (0.37 N/tex) and the lowest strain using the ear with a rod method (0.31), the strain values for the nonknotted and ear without a rod specimens being similar (0.37; 0.38). Tenacity and strain for knotted specimens were affected by gauge length and by test speed (tenacity F2,io8 = 10.883, P < .001; F2,io8 = = 20.424, P < .001) (strain F2,io8 = 220.509, P < .001; F2,io8 = 6.634, P < .01 ). A lower tenacity was measured at a gauge length of 50 mm (0.44 N/tex), tenacity at the longer gauge lengths were similar to each other (250 mm 0.49 N/tex; 500 mm = 0.51 N/tex). Lower tenacity was also measured at the greater test speeds (1000 mm/s 0.43 N/tex; 500 mm/s = 0.49 N/tex; and 250 tnm/s = 0.52 N/tex). Lower strain was measured at longer gauge lengths (500 mm = 0.25; 250 mm = 0.28; and 50 mm = 0.52) and at greater test speeds (1000 mm/s = 0.33; 500 mm/s = 0.36; and 250 mm/s = 0.38). A comparison of results from experiments 4 and 5 allowed for the effects of the following variables to be examined for knotted specimens tested using the cut-loop and ear method(/) knot tensioning force, (//) gauge length, and (ii'O test speed. The knot-tensioning force used did not affect tenacity nor strain (Fi,36 = 2.537, P = NS; Fi,36 = 0.827, P NS). Tenacity and strain were affected by test speed and gauge length (tenacity F2,36 = 147.516, P < .001; F2,36 = 235.913, P < .OOland strain F2,36 = 63.766, P < 001; F2,36 = 57.645, P < .001). Tenacity was lower when measured with a gauge length of 50 mm (0.77 N/tex) than for longer gauge lengths that were in the same Tukey group (250 mm = 0.92 N/tex; 500 mm = 1.00 N/tex) and at faster test speeds (250 mm/min = 0.99 N/tex; 500 mm = 0.90 N/tex; 1000 mm/min = 0.81 N/tex). Strain was lower for longer gauge lengths, results for 250 mm and 500 mm being in the same Tukey group (0.21 N/tex; 0.22 N/tex) than for

The Journal of The Textile Institute 1954; Smith et al., 1961). However, resuhs reported by Meredith (1954) showed an initial increase in strain with strain rate (e.g. 15.9% at 0.0013%/s to 20.7% at 22%/s), followed by decreasing strain with increasing strain rate (e.g. 14.5% at 1096%/s). The strain results obtained can be explained by considering variability in the diameter of the material along its gauge length that results in the development of differing stress levels (Morton & Hearle, 1993). Higher stress levels will occur in regions of smaller diameter potentially resulting in premature failure of the specimen, that is, failure at lower values of strain. The probability of variation in diameter of the material and the probability of the presence of a ftaw of critical length (weak link theory) will be higher for longer gauge lengths, these factors contributing to lower measured values of strain at longer gauge lengths (Morton & Hearle, 1993). Lower tenacity was measured with shorter gauge lengths and greater test speeds for both nonknotted and knotted specimens. These results were not expected. It is generally accepted that tenacity for polyamide (monofilaments and multifilaments) is higher at shorter gauge lengths (weak link theory) and at greater test speeds (reduced time to creep) (Meredith, 1954; Morton & Hearle, 1993; Smith et al., 1961). With respect to the unexpected lower tenacity measured for shorter gauge lengths in this work, it is worth reiterating that results for gauge lengths of 250 mm and 500 mm were in the same Tukey group, and only the tenacity for 50 mm specimens was significantly different. Higher breaking forces have been reported for various seams for longer gauge lengths (352 N at 40 mm, 470 N at 150 mm, and 568 N at 375 mm) (Bumip, Wilkinson, & Dorkin, 1977). For the shorter gauge-length specimens, the strain field caused by jaw deformation may have influenced the measured tenacity (Morton & Hearle, 1993). Considering the observed effect of test speed on tenacity, data published by Hall (1968) for multifilament nylon-6,6 yarn follows the general trend of higher tenacity with greater test speed and a slightly lower tenacity at a strain rate of 0.32/s (~46 g/tex) compared with 0.049/s (~48 g/tex). Interestingly, in the same article. Hall also reports a slightly lower tenacity for polyethylene terephalate at a strain rate of 1.2/s (~37 g/tex) compared with 0.013/s (~39 g/tex).

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testing can be compared only with other work in which the same environment, material, knot, knot-tensioning load, gauge length, and test speeds were used.

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