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. 2018 Jul 3;2018(7):CD012522. doi: 10.1002/14651858.CD012522.pub2

Keskin 2008.

Methods 2‐arm RCT
Conducted in Turkey
Follow‐up: 10 days
Participants 40 participants with lower extremity, non‐diabetic, post‐traumatic wounds
Inclusion criteria: age ≥ 18 years; had given written informed consent to participate; were haemodynamically stable; well‐orientated; and were able to co‐operate in answering the questions
Exclusion criteria: none stated, however, none of the participants had any other chronic illnesses; none used mood modifying drugs or anxiolytics at the time of the study
Interventions Group A (n = 20 participants): standard moist wound care. After debridement wound closure with standard moist gauze dressings that were changed daily
Group B (n = 20 participants): VAC. VAC black polyurethane foam was placed over the wound after debridement, a VAC drape was placed over the foam and then pressure was applied at 125 mmHg intermittently. Dressings were changed 3 times/week
Outcomes Primary review outcomes: none reported
Secondary review outcomes: none reported
Notes Funding source was not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: “They were randomly distributed into two groups according to the way that their wounds were treated”
Comment: insufficient information
Allocation concealment (selection bias) Unclear risk Quote: see above
Comment: methods of allocation concealment unclear
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: “There was no blinding between the two groups since the researcher could see which dressing material was being used on a particular wound during dressing change”
Comment: no mention of blinding but would not be possible to blind health professionals to the different treatments so without further detail considered high risk
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Quote: no quote
Comment: not stated
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: “Patients who had been discharged before the 10th day were excluded from the study and new patients enrolled.”
Comment: clarified the procedure of exclusion
Selective reporting (reporting bias) Low risk Quote: no quote
Comment: study protocol was not available, however, all expected outcomes appear to have been reported
Other bias High risk Quote: no quote
Comment: the difference in frequency of change of wound dressings may have resulted in bias. The assignment of additional participants to study groups to replace those lost to follow‐up may not have been done at random.