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Table 2 Unpublished studies considered for assessment of potential publication bias

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

Study

Sample sizea

Documents available (e.g. study registry number, study protocol, CSR)

Recruitment status (estimated study completion dateb)

ACTRN12614000056695

40

ACTRN12614000056695 [35]/--

Completed (December 2013)

Adams et al. (2005) [6]

1c

--/--

Completed (March 2005)d

ATEC

112

ISRCTN60292377 [36]/--

Completed (September 2016)

B2108R [6]

120

NCT00011531 [37]/--

Completed (December 2001)

CTRI/2018/01/011503

54

CTRI/2018/01/011503 [38]/--

Completed (April 2017)

foryou

48

ChiCTR-TRC-12002700 [39]/--

Completed (December 2015)e

VACOTOL-012

28

NCT02102685 [40]/--

Completed (September 2013)

VSD

119

ChiCTR-IOR-16008087 [41]/--

Completed (March 2016)e

045-1502-226 [6]

30

NCT00121537 [42]/--

Terminated (October 2015)e

2008/2023-31

30f

NCT01191567 [43]/--

Terminatedf (July 2012)

ANSM

36

NCT02509533 [44]/--

Terminated (July 2015)

Greer et al. (1999) [6]

16g

--/study protocolh [45], raw datah, i [46]

Terminated (November 1999)g

HTA012-0801-01

184

NCT00691821 [47]/--

Terminated (July 2011)e

STOMAVAC

14g

ISRCTN37399763 [48]/--

Terminated (December 2014)

U1111-1132-0768

30

ACTRN12612000702819 [49]/--

Terminatedf (n.s.)J

U1111-1133-5694

0f

ACTRN12612000885897 [50]/--

Terminatedf (n.s.)

U1111-1162-0654

16f

ACTRN12614001068651 [51]/--

Terminatedf (n.s.)J

VAC 2001-00 [6]

46

-- /study protocolh [52], CSRh,k [53]

Terminatedg (n.s.)J

VAC 2006-19

19g

NCT00837096 [54]/study protocolh [55]

Terminated (October 2013)e

VAC TRIAL

9

ACTRN12606000384550 [56]/study protocolh [57]

Terminated (September 2005)

2015046

80

NCT02374528 [58]/--

Unknown (April 2016)

382094-2

30

NCT01857128 [59]/--

Unknown ( December 2014)

ACTRN12609000149268

60

ACTRN12609000149268 [60]/--

Unknownl (n.s.)J

ACTRN12609000995279

100

ACTRN12609000995279 [61]/--

Unknownl (n.s.)J

CTRI/2014/02/004390

40

CTRI/2014/02/004390 [62]/--

Unknownl (n.s.)J

Foo et al. (2004) [6]

--m

--/--

Unknownd (n.s.)

Gupta et al. (2001) [6]

1c

--/--

Unknownd (n.s.)

ITIQ002A

90

NCT01734109 [63]/--

Unknown (March 2014)

McCarthy M 2005

1c

--/--

Unknown (n.s.)J

NPWTvsGPA

32

NCT02314468 [64]/--

Unknown (October 2016)

  1. CSR clinical study report, n.s. not specified
  2. aNumber of patients counted as missing; according to study registry information, if not stated otherwise
  3. bAccording to study registry information, if not stated otherwise
  4. cNot known; N = 1 used as a placeholder
  5. dAccording to status of previous HTA report N04-03; no further information available
  6. eDate of last study registry update; study may have been completed/terminated for a longer period of time
  7. fAccording to author’s reply
  8. gAccording to a manufacturer’s reply
  9. hNot publically available
  10. iRaw data provided by a manufacturer; refer to less than 70% of included patients; no data for planned patient-relevant outcomes included
  11. jAccording to the available information study, study should have been completed/terminated for more than 12 months
  12. kIt is not possible to certainly assign the CSR provided by the manufacturer to the study under investigation. Furthermore, several pages had been deleted
  13. lClassification as “unknown” as the status had not been updated within the 2 years before our literature search
  14. mAccording to the previous HTA report N04-03 [6], change in wound surface should have been investigated. This outcome does not represent a patient-relevant outcome. The study was not further taken into account
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Systematic Reviews

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