Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital-acquired pressure ulcers: a pragmatic noncommercial multicentre randomized open-label parallel-group medical device trial.

BACKGROUND: Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs). OBJECTIVES: To determine whether silicone foam dressings in addition to standard prevention reduce the incidence of PUs of category 2 or worse compared with standard prevention alone. METHODS: This was a multicentre, randomized controlled medical device trial conducted in eight Belgian hospitals. At-risk adult patients were centrally randomized (n = 1633) to study groups based on a 1 : 1 : 1 allocation: experimental groups 1 (n = 542) and 2 (n = 545) - pooled as the treatment group - and the control group (n = 546). The experimental groups received PU prevention according to hospital protocol, and a silicone foam dressing on the relevant body sites. The control group received standard of care. The primary endpoint was the incidence of a new PU of category 2 or worse at the studied body sites. RESULTS: In the intention-to-treat population (n = 1605), PUs of category 2 or worse occurred in 4·0% of patients in the treatment group and 6·3% in the control group [relative risk (RR) 0·64, 95% confidence interval (CI) 0·41-0·99, P = 0·04]. Sacral PUs were observed in 2·8% and 4·8% of the patients in the treatment group and the control group, respectively (RR 0·59, 95% CI 0·35-0·98, P = 0·04). Heel PUs occurred in 1·4% and 1·9% of patients in the treatment and control groups, respectively (RR 0·76, 95% CI 0·34-1·68, P = 0·49). CONCLUSIONS: Silicone foam dressings reduce the incidence of PUs of category 2 or worse in hospitalized at-risk patients when used in addition to standard of care. The results show a decrease for the sacrum, but no statistical difference for the heel and trochanter areas.

Multi-stage versus single-stage inflation and deflation cycle for alternating low pressure air mattresses to prevent pressure ulcers in hospitalised patients: a randomised-controlled clinical trial.

INTRODUCTION: The duration and the amount of pressure and shear must be reduced in order to minimize the risk of pressure ulcer development. Alternating low pressure air mattresses with multi-stage inflation and deflation cycle of the air cells have been developed to relieve pressure by sequentially inflating and deflating the air cells. Evidence about the effectiveness of this type of mattress in clinical practice is lacking. AIM: This study aimed to compare the effectiveness of an alternating low pressure air mattress that has a standard single-stage inflation and deflation cycle of the air cells with an alternating low pressure air mattress with multi-stage inflation and deflation cycle of the air cells. METHODS AND MATERIALS: A randomised controlled trial was performed in a convenience sample of 25 wards in five hospitals in Belgium. In total, 610 patients were included and randomly assigned to the experimental group (n=298) or the control group (n=312). In the experimental group, patients were allocated to an alternating low pressure air mattress with multi-stage inflation and deflation cycle of the air cells. In the control group, patients were allocated to an alternating low pressure air mattress with a standard single-stage inflation and deflation cycle of the air cells. The outcome was defined as cumulative pressure ulcer incidence (Grade II-IV). An intention-to-treat analysis was performed. RESULTS: There was no significant difference in cumulative pressure ulcer incidence (Grade II-IV) between both groups (Exp.=5.7%, Contr.=5.8%, p=0.97). When patients developed a pressure ulcer, the median time was 5.0 days in the experimental group (IQR=3.0-8.5) and 8.0 days in the control group (IQR=3.0-8.5) (Mann-Whitney U-test=113, p=0.182). The probability to remain pressure ulcer free during the observation period in this trial did not differ significantly between the experimental group and the control group (log-rank χ(2)=0.013, df=1, p=0.911). CONCLUSION: An alternating low pressure air mattress with multi-stage inflation and deflation of the air cells does not result in a significantly lower pressure ulcer incidence compared to an alternating low pressure air mattress with a standard single-stage inflation and deflation cycle of the air cells. Both alternating mattress types are equally effective to prevent pressure ulcer development.

Pressure ulcers: development and psychometric evaluation of the attitude towards pressure ulcer prevention instrument (APuP).

BACKGROUND: Pressure ulcers continue to be a significant problem in hospitals, nursing homes and community care settings. Pressure ulcer incidence is widely accepted as an indicator for the quality of care. Negative attitudes towards pressure ulcer prevention may result in suboptimal preventive care. A reliable and valid instrument to assess attitudes towards pressure ulcer prevention is lacking. AIMS AND OBJECTIVES: Development and psychometric evaluation of the Attitude towards Pressure ulcer Prevention instrument (APuP). DESIGN: Prospective psychometric instrument validation study. METHODS: A literature review was performed to design the instrument. Content validity was evaluated by nine European pressure ulcer experts and five experts in psychometric instrument validation in a double Delphi procedure. A convenience sample of 258 nurses and 291 nursing students from Belgium and The Netherlands participated in order to evaluate construct validity and stability reliability of the instrument. The data were collected between February and May 2008. RESULTS: A factor analysis indicated the construct of a 13 item instrument in a five factor solution: (1) attitude towards personal competency to prevent pressure ulcers (three items); (2) attitude towards the priority of pressure ulcer prevention (three items); (3) attitude towards the impact of pressure ulcers (three items); (4) attitude towards personal responsibility in pressure ulcer prevention (two items); and (5) attitude towards confidence in the effectiveness of prevention (two items). This five factor solution accounted for 61.4% of the variance in responses related to attitudes towards pressure ulcer prevention. All items demonstrated factor loadings over 0.60. The instrument produced similar results during stability testing [ICC=0.88 (95% CI=0.84-0.91, P<0.001)]. For the total instrument, the internal consistency (Cronbachs alpha) was 0.79. CONCLUSION: The APuP is a psychometrically sound instrument that can be used to effectively assess attitudes towards pressure ulcer prevention in patient care, education, and research. In further research, the association between attitude, knowledge and clinical performance should be explored.

Pressure ulcer prevention: development and psychometric validation of a knowledge assessment instrument.

BACKGROUND: Profound knowledge of pressure ulcers is important to enable good prevention. Validity and reliability of instruments assessing pressure ulcer knowledge are limited evaluated in previous research. AIMS AND OBJECTIVES: To develop a valid and reliable instrument to assess knowledge of pressure ulcer prevention. DESIGN: Prospective psychometric instrument validation study. METHODS: An extensive literature review was performed to develop an instrument to assess knowledge of pressure ulcer prevention. Face and content validity were evaluated in a double Delphi procedure by an expert panel of nine trustees of the European Pressure Ulcer Advisory Panel (EPUAP) who each have extensive experience in pressure ulcer care and research (PhD level). A convenience sample of 608 nurses and nursing students from Belgium and The Netherlands participated to evaluate validity of the multiple-choice test items (item difficulty, discriminating index, quality of the response alternatives), construct validity, internal consistency, and stability of the instrument. The data were collected between February and May 2008. RESULTS: A 26-item instrument was developed, reflecting 6 themes expressing the most relevant aspects of pressure ulcer prevention. The content validity was excellent (CVI=0.78-1.00). Group scores of nurses with a (theoretically expected) high level of expertise were found to be statistically significantly higher than those of participants with (theoretically expected) less expertise (P<0.001). The item difficulty index of the questions ranged from 0.27 to 0.87, while values for item discrimination ranged from 0.29 to 0.65. The quality of the response alternatives was found to be good. The overall internal consistency reliability (Cronbach's alpha) was 0.77. The 1-week test-retest intraclass correlation coefficient (stability) was 0.88. CONCLUSION: The instrument demonstrated acceptable psychometric properties and can be applied in both research and practice for evaluating knowledge about pressure ulcer prevention.