| Methods |
RCT with 60‐day follow‐up.
Median length of follow‐up (days):
Group 1: 4 (1‐60).
Group 2: 6 (1‐62) P value <0.017. |
| Participants |
Acute and long‐term care patients incontinent of urine and/or faeces, in bed >16 h/day, with pressure ulcers grade 2 or below (or none). If urinary catheter present, this was removed in the LAL group (not control group). Most common diagnoses: sepsis; malignancy; fractured neck of femur; hypovolaemia; dementia. |
| Interventions |
Group 1. Low‐air‐loss Hydrotherapy (LAL) (n = 42) Clensicair (SSI/Hill Rom). Permeable fast drying filter sheet over low‐air‐loss cushions (circulating air). Urine collection device integral to bed.
Group 2. Standard care (n = 56) comprised standard bed or foam, air, alternating‐pressure mattresses. Skin care not standardised. |
| Outcomes |
Number of patients who developed any kind of skin lesion more than 1 day after enrolment:
Group 1: 64% (27/42);
Group 2: 18% (10/56).
Number of patients who developed pressure ulcers Grade 2‐4:
Group 1: 19% (8/42);
Group 2: 7% (4/56) P value 0.11; NS.
Number of patients with non‐blanchable erythema (Grade 1):
Group 1: 14% (6/42);
Group 2: 0/56 P value 0.008.
Only 26 ulcers present on enrolment, and only 3 were Grades 3 or 4, so no healing data presented. |
| Notes |
The first 68 patients were discounted, and a further 26 out of 116 withdrew. No ITT analysis. Nurses received special extra training for the LAL bed. LAL patients were interviewed about satisfaction, control patients were not. There were many nurse complaints about the LAL; firmly held belief that it was associated with more ulceration. Two subjects in the LAL group developed hypothermia. Findings may not relate to subsequent products developed since. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Randomization of subject to low‐air‐loss hydrotherapy or standard care was done by unblocked allocation using a table of random numbers stratified by pressure sore and by setting". |
| Allocation concealment (selection bias) |
Unclear risk |
Method of concealment not described. |
| Blinding (performance bias and detection bias)
Pressure ulcer incidence |
Unclear risk |
Not reported. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Shown in Table 2 and reported in text. |
| Selective reporting (reporting bias) |
High risk |
"Because too few patients with pressure sores at enrolment were enrolled long enough to have changes in pressure sore size, grade, or status, no data on change in pressure sores present at enrolment are presented herein". |
| Free of other bias ‐ were groups similar at baseline regarding the most important prognostic indicators? |
Low risk |
"There were no statistically significant differences in enrolment characteristics between the two groups". |
| Free of other bias ‐ was the timing of the outcome assessment similar in all groups? |
High risk |
"For all subjects, the study treatment period commenced on the day of enrolment and continued until withdrawal of consent, discharge from the hospital, transfer to a critical care unit from a medical‐surgical ward or to the acute hospital from the chronic hospital ward, death, cessation of incontinence, bed use less than 16 hours per day, enrolment for more than 60 days, or end of the overall study". |
