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.