Şahin 2022.
Study characteristics | ||
Methods | 2‐arm RCT Conducted in‐home and hospital settings in 1 geographical location in the UK The duration of follow‐up was a maximum of 24 weeks |
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Participants | 30 participants: all included in the analysis Inclusion criteria listed: (1) being ≥18 years old; (2) not having time/access constraints; (3) voluntariness Exclusion criteria listed:(1) Stage I and Stage II pressure ulcers; (2) cancer; (3) increased risk of bleeding; (4) osteomyelitis; (5) corticosteroid treatment; (6) contraindications of NPWT (fistula, necrotic tissue in the wound, burn wound, cardiorespiratory disease) |
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Interventions | Group A: the wounds were initially evaluated for any necrotic findings and debrided if needed, and then washed with an antiseptic solution. Wound depth was determined in centimetres with a sterile cotton‐tip applicator by measuring against a ruler. The wound was closed using a Wound Care Kit that includes foam dressing (V.A.C. Granu Foam Silver), film drape, TRAC pad with tubing, and a drainage canister. Steril foam material was placed inside the wound and was attached to the canister through the tubing. The canister was attached to the Vacuum‐Assisted Closure device (V.A.C.® Therapy System Patient Support – KCI), which is a portable device that applies intermittent or continuous negative pressure. The device was operated at 125 mmHg pressure for 5 min with and 2 min without an active vacuum. Wound dressings were changed every 48 h. Group B: the wound was initially evaluated for any necrotic findings and debrided if needed, and then washed with an antiseptic solution. 3DWM was used to measure the pressure sores by taking pictures. Wounds were finally covered with gauze dressing soaked with saline. Wounds were treated three times a day, and measurements were repeated every 48 h. |
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Outcomes | Primary outcomes: none Secondary outcomes: PUSH Tool Change in wound size |
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Notes | Funding source: no financial support | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "the subjects were divided into experimental and control groups according to their respective protocol numbers. The protocol numbers ending with odd digits were assigned to the control group, and those ending with even digits were assigned to the experimental group." Commend: information cannot determine how the protocol number is generated. |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | Low risk | quote: "Its consort trial number is NCT04311229." Commend: the study protocol is available and all of the study’s prespecified (primary and secondary) outcomes that are of interest in the review have been reported in a prespecified way |
Other bias | Low risk | Comment: no other clear sources of bias was found |
Abbreviations
h: hour; ITT: intention to treat; min: minute; NPD: negative pressure device; NPWT: negative pressure wound therapy; PUSH: pressure ulcer scale for healing; RCT: randomised controlled trial