Ramos‐Torrecillas 2015.
Study characteristics | ||
Methods |
Research design: randomised, open‐label, clinical trial Care setting: 1 long‐stay hospital and 4 geriatric centres Country of origin: Granada (Spain) Publication source:Biological Research for Nursing Year of publication: 2014 Duration of follow‐up: 36 days Sources of funding: none Unit of randomisation: participant Unit of analysis: ulcer Inclusion criteria: the presence, for more than 8 weeks, of stage II or III pressure ulcers (European Pressure Ulcer Advisory Panel classification), with the largest diameter ≤ 10 cm and showing presence of granulation tissue and the absence of infection and/or necrotic tissue Exclusion criteria: the receipt of immunosuppressive treatment or the presence of cancer, HIV infection, hepatitis, systemic infection or clinical signs compatible with active local infection, active vasculitis, systemic erythematous lupus, or cryoglobulinaemia |
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Participants |
Number of participants: 115 participants (ITT), rendering a final study sample of 100 participants (per‐protocol) with 124 stage II to III pressure ulcers. We were able to pool data from 2 arms of the study where hyaluronic acid was the only systematic difference between treatments. Female gender: 60% (n = 60) Age: 82.5 ± 4.7 |
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Interventions |
Details of the intervention: Group 1: control group (standard pressure ulcer care) (25 pressure ulcers) Group 2: 1 dose of PRGF (34 pressure ulcers) Group 3: 2 doses of PRGF (25 pressure ulcers) Group 4: 2 doses of PRGF plus HA (40 pressure ulcers) Multiple pressure ulcers in the same participant were treated with the same procedure. Dressing procedure: throughout the study, all participants were treated every 3 days according to the standard hospital protocol: ulcer debridement, cleaning with physiological saline and sterile gauze, application of liquid hydrogel (Intrasite1 Gel, Smith & Nephew, Barcelona, Spain), and placement of a polyurethane dressing (Mepilex Border Lite1, Molnlycke Health Care, Madrid, Spain). PRGF was applied before placement of the dressing on day 0 of the study in treatment group 1 and on days 0 and 15 of the study in treatment groups 3 and 4, in combination with HA in the case of group 3. Co‐interventions: all participants were turned every 2 hours, and the progression of the ulcer was followed using the Pressure Ulcer Scale for Healing (PUSH) Duration of treatment: 36 days |
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Outcomes |
Primary outcomes of the review: percentage of completely healed pressure ulcers; adverse effects Secondary outcomes: change in ulcer size |
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Notes | Losses to follow‐up: 15 participants | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "We used a computer‐generated randomisation table to randomly assign participants to a control group (standard PU care) or treatment group A (one dose of PRGF), B (two doses of PRGF), or C (two doses of PRGF plus HA)" |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label study |
Incomplete outcome data (attrition bias) All outcomes | High risk | Reported the numbers who withdrew per study but did not provide reasons or further details (15 lost to follow‐up, 13%). Did not conduct an intention‐to‐treat analysis and multiple ulcers were assessed in the same volunteer. |
Selective reporting (reporting bias) | Low risk | The protocol is not available but all proposed outcomes described in methods section are presented and properly analysed. |
Other bias | High risk | Data analysis was based on number of ulcers that exceed the number of randomised participants. There is not enough detail for participants characteristics in each group at baseline (such as demographics, anthropometrics, etc). |