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Minerva Chirurgica 2013 February;68(1):105-16


language: English

A controlled, randomized study on the effectiveness of two overlays in the treatment of decubitus ulcers

Cassino R. 1, Ippolito A. M. 1, Cuffaro C. 2, Corsi A. 3, Ricci E. 4

1 Vulnera Centro Vulnologico Italiano, (Italian Vulnological Centre), Turin, Italy; 2 Villa Grazia Nursing Home, Long-Term Medical Department, Turin, Italy; 3 Chronic Wounds Clinic, Santa Maria Nuova in Firenze Hospital, Florence, Italy; 4 Surgery 2, Difficult Wounds, San Luca Clinic, Turin, Italy


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.

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