A controlled, randomised study on the efficacy of two overlays in the treatment of decubitus ulcers

Abstract

Aim: The aims of this study were to evaluate the performance and effectiveness of an antibedsore overlay in 3D structure of new conception towards an overlay of common use. Evaluation parameters: wound area reduction, healing, safety and comfort.

Methods: Open randomized multicenter study comparing the two overlays for the treatment and prevention of pressure sores. Patients were recruited in long-term carewards. Recruitment and randomization systems were made using envelopes, with goal of 70 patients with pressure ulcers from I to IV degree. Observation period was extended for 12 weeks. Data collection was made using paper CRF.

Results: We enrolled 72 patients: 35 in the study group and 37 in the control. The two groups were similar. Mortality during the observation period was 13.8% (unrelated events). Approximately 50% of patients withdrew from the study before the end (trend in favor of the overlay three-dimensional). The resolution of the lesions occurred in 8 cases (11.1%), 3 cases in the overlay 3D and 5 in the gel group (P=NS). The reduction of the area was in favor of the three-dimensional overlay (P<0.005%), data with significance were obtained also in patient comfort (P=0.08) and ease of care (P<0.001).

Conclusion: The first objective of this study was to evaluate the effectiveness of an innovative antibedsore overlay versus a commonly used one. The data obtained showed a better performance, both in terms of treatment of lesions and in terms of comfort for the patients and the operators.