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Randomised controlled trial comparing alternating pressure overlays with alternating pressure mattresses for pressure sore prevention and treatment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78646179
Enrollment
1972
Registered
2003-04-25
Start date
2000-05-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure sores Skin and Connective Tissue Diseases Pressure sores

Interventions

Patients at moderate to high risk of developing a pressure sore will be randomised (stratified, 24 hour telephone) to either: 1. An Alternating-pressure Replacement mattress (AR) 2. An Alternating pre

Sponsors

Department of Health (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged > 55 years who are admitted to a vascular, orthopaedic or care of the elderly ward with an expected length of stay of at least 7 days AND who are completely immobile/have very limited mobility on admission; or have a pre-existing grade 1, 2 or 3 pressure sore on admission. Patients admitted before elective surgery who are expected to be completely immobile/have very limited mobility for at least 3 days after surgery may also be included.

Exclusion criteria

Exclusion criteria: Patients who have a pre-existing grade 4 or 5 pressure sore on admission, have participated in this trial previously or are unable/unwilling to give full informed consent.

Design outcomes

Primary

MeasureTime frame
The occurrence of a first or new sore at or above the level of superficial damage to the skin (break/blister) before discharge will be considered as a treatment failure.

Secondary

MeasureTime frame
1. Worsening/healing of existing sores 2. Patients' perceptions 3. Time to occurrence 4. Site of sore 5. Economic costs including those incurred in the treatment of pressure sores in the community, post-discharge Skin assessments will be made daily by qualified attendant nursing staff and validated twice weekly by research nurses. Health economic results comparing the costs and benefits of the expensive with the cheaper mattresses, will be expressed as incremental cost effectiveness ratios.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026