Keskin 2008.
Methods | 2‐arm RCT Conducted in Turkey Follow‐up: 10 days |
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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 |
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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 |
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Outcomes |
Primary review outcomes: none reported Secondary review outcomes: none reported |
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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. |