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.