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. 2011 Jun 3;108(22):381–389. doi: 10.3238/arztebl.2011.0381

Table 2. Trial and patient characteristics in the newly-identified randomized controlled trials (RCTs).

RCT Sites Recruitment period FU (days) Random‧ized patients Dropout or LTFU Dropout or LTFU by ITT Mean age Sex: % male Mean wound surface area (cm2) Comorbidities (%)
I vs. C I vs. C I vs. C I vs. C I vs. C I vs. C I vs. C
Commercially available systems
Blume 2008 (8)*1 5 (USA) 2002 to 2005 112 172 vs. 169 59 vs. 52 3 vs. 3 58 vs. 59 83 vs. 73 14 vs. 11 n/a
Chio 2010 (9)*2 1 (USA) 2007 to 2009 30 27 vs. 27 4 vs. 0 4 vs. 0 62 vs. 58 61 vs. 60 73 vs. 69 39 vs. 26
Keskin 2008 (10)*3 1 (Turkey) n/a 10 20 vs. 20 n/a n/a n/a n/a n/a 0 vs. 0
Stannard 2009 (11)*4 1 (USA) 2001 to 2006 840 35 vs. 23 0 0 n/a 74 vs. 57 65 vs. 58 n/a
Systems not commercially available
Bee 2008 (12) 1 (USA) 2003 to 2007 n/a 31 vs. 20 2 vs. 1 2 vs. 1 44 vs. 37 81 vs. 85 n/a n/a
Mody 2008 (13)*5 1 (India) n/a 214 19 vs. 36 5 vs. 15 4 vs. 3 54 72 67 vs. 121 n/a
Perez 2010 (14)*6 1 (Haiti) 2007 n/a 25 vs. 24 5 vs. 4 5 vs. 4 49 vs. 44 60 vs. 45 45 vs. 40 35 vs. 30
Saaiq 2010 (15) 1 (Pakistan) 2007 to 2009 n/a 50 vs. 50 n/a n/a 33 86 65 n/a
Sepúlveda 2009 (16)*7 1 (Chile) 2006 to 2007 n/a 12 vs. 12 0 0 62 vs. 62 83 vs. 75 n/a 42 vs. 33

LTFU: Lost to follow-up; ITT: intention to treat; I: Intervention group = negative-pressure wound therapy (NPWT); C: Control group; n/a: Not available;

*1Blume 2008: Allocation to groups: 172 NPWT vs. 169 control; NPWT/control group: 3/3 no NPWT + 1/5 LTFU + 54/43 trial terminated + 1/1 incomplete data = 59/52 dropout or LTFU

*2Chio 2010: Comorbidities were diabetes mellitus, peripheral vascular disease, hypothyroidism, and long-term steroid treatment.

*3Keskin 2008: Comorbidities were diabetes mellitus; 40 patients: mean age 38 years, 60% male.

*4Stannard 2009: Mean length of observation period (days); wound surface area was calculated from length and breadth.

*5Mody 2008: Mean length of observation period (days); dropouts after randomization, before treatment 4:3; LTFU before wound closure 1:12; mean wound surface area calculated on the basis of data on 4 wound categories.

*6Perez 2010: Comorbidities were diabetes mellitus.

*7Sepúlveda 2009: Comorbidities were dyslipidemia receiving drug treatment; proportion of patients with hypertension not stated.