Negative pressure wound therapy in patients with wounds healing by secondary intention: a systematic review and meta-analysis of randomised controlled trials

Zens, Yvonne; Barth, Michael; Bucher, Heiner C.; Dreck, Katrin; Felsch, Moritz; Groß, Wolfram; Jaschinski, Thomas; Kölsch, Heike; Kromp, Mandy; Overesch, Inga; Sauerland, Stefan; Gregor, Sven

doi:10.1186/s13643-020-01476-6

Systematic Reviews

Table 4 Risk of bias of included studies

From: Negative pressure wound therapy in patients with wounds healing by secondary intention: a systematic review and meta-analysis of randomised controlled trials

Study	Randomisation appropriate	Allocation concealment appropriate	Blinding		Selective reporting improbable	Absence of other factors potentially causing bias	Risk of bias: study level ^a	Risk of bias: outcome level^b
Study	Randomisation appropriate	Allocation concealment appropriate	Patients	Treating staff	Selective reporting improbable	Absence of other factors potentially causing bias	Risk of bias: study level ^a	Risk of bias: outcome level^b
Acosta et al. (2013) [65,66,67]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Arti et al. (2016) [68, 69]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Ashby et al. (2012) [70, 71]	Yes	Yes	no	no	unclear	yes	Low	Low/high^c
Banasiewicz et al. (2013) [72]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Bee et al. (2008) [73]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Biter et al. (2014) [74, 75]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Braakenburg et al. (2006) [76]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
CE/044/PIC [77,78,79,80,81,82]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Chiang et al. (2017) [83]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Correa et al. (2016) [84, 85]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Dalla Paola et al. (2010) S-II [86]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
De Laat et al. (2011) [87, 88]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
DiaFu [89,90,91,92,93,94,95]	Yes	Yes	no	no	yes	yes	Low	High
Gupta et al. (2013) [96]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Hu et al. (2009) [97]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Huang et al. (2006) [98]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Jayakumar et al. (2013) [99]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Kakagia et al. (2014) [100]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Karatepe et al. (2011) [101]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Leclercq et al. (2016) [102]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Liao et al. (2012) [103]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Llanos et al. (2006) [104]	Yes	Yes	no	no	unclear	yes	Low	Low
Mody et al. (2008) [105]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Mohsin et al. (2017) [106]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Moisidis et al. (2004) [107]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Mouës et al. (2004) [108,109,110]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Nain et al. (2011) [111]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Novinščak et al. (2010) [112]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Perez et al. (2010) [113]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Rencüzoğulları et al. (2015) [114]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Saaiq et al. (2010) [115]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Shen et al. (2013) [116]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Sibin et al. (2017) [117]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Sinha et al. (2013) [118]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
SWHSI [119,120,121]	Yes	Yes	no	no	yes	yes	Low	Low/high^d
TOPSKIN [122,123,124]	Unclear	Yes	no	no	no	yes	High	High
VAC (2001–01) [125,126,127]	Yes	Yes	no	no	no	no^e	High	High
VAC (2001–02) [126, 128, 129]	Yes	Yes	no	no	no	no^f	High	High
VAC (2001–03) [130, 131]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
VAC (2001–06) [132,133,134]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
VAC (2001–07) [135,136,137,138,139,140,141]	Yes	Yes	No	No	Yes	Yes	Low	High
VAC (2001–08) [142,143,144,145,146,147,148,149]	Yes	Yes	No	No	No	Yes	High	High
VAC (2002–09) [126, 150, 151]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
VAC (2002–10) [126, 152, 153]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Virani et al. (2016) [154]	Yes	Unclear	n. a.	n. a.	n. a.	n. a.	High	High
Vuerstaek et al. (2006) [155,156,157]	Yes	Yes	No	No	Yes	Yes	Low	High
WOLLF [158,159,160,161]	Yes	Yes	No	No	Unclear	Yes	Low	High
Xu et al. (2015) [162]	Unclear	Unclear	n. a.	n. a.	n. a.	n. a.	High	High

n. a. not applied
^aIf the evaluation of the items “random sequence generation“ and “allocation concealment“ revealed a high risk of bias, no further evaluations of the remaining items were performed
^bDetails are given in Tables 1 to 8 in Additional file 2
^cThe outcomes pain and adverse events (wound bleeding and infection) showed a high risk of bias
^dThe outcomes adverse events, pain, duration of hospital stay and quality of life showed a high risk of bias
^eIn the control group and in the NPWT group, 27.8% and 7.7% of the patients respectively discontinued the study due to treatment failure. The time point of study discontinuation was documented as the final study visit date
^fOnly data from 146 out of 205 randomised patients available (71.2%)

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