STUDY 1. STUDY ABOUT THE INCREASE OF TOUCH SENSITIVITY WITH SENSIFEMME GLOVE
Objective: To determine the capacity of increasing the touch sensitivity of fingertips by using a glove for breast self-examination.
Method: The study was carried out with 15 volunteers of ages between 20 and 60 years old who had their eyes covered. The study was conducted with micro spheres of between 0.04 and 1.40 millimeters. In turns, the volunteers had to put on the glove in one hand, with the other one bare. Then they found out that the touch of the particles was different with both hands.
• Between 93.2% (right hand) and 100% (left hand) of cases increased 3.3 times the sensitivity of touch.
• Between 53.3% (right hand) and 67% (left hand) of cases increased 6.6 times the sensitivity of touch.
• Between 20% (right hand) and 14% (left hand) of cases increased 8.3 times the sensitivity of touch.
• Another conclusion we obtained was that the smaller the particle size was, the more capable is Sensifemme to magnify the tactile sensitivity, making it very suitable for early detection of small breast lumps.
Institution: Biotechnology Department of the University of Alicante (Spain)
STUDY 2. SENSIFEMME DEVICE EVALUATION OF CLINICAL EFFICACY IN BREAST NODULE DIAGNOSTIC
Authors: Sanvido,V.M.;Elias,S.; Araújo Neto, J.T; Facina, G.; Nazário, A.C.P. Acronym: G022
Objective: Sensifemme device is a glove with three layers of polyurethane with a thickness of 0.5 mm which has mineral oil between its layers. The glove was developed in order to allow examiner’s hand slip easily over the breast. The objective of this study was to evaluate the clinical efficacy of Sensifemme device in the diagnosis of node breast.
Method: A randomized clinical study in which 202 Mastology Discipline patients of Gynecology Department in the Paulista School of Medicina from Federal University of São Paulo, were examined by clinical examination with Sensifemme device. After this examination all patients had bilateral ultrasound to confirm or exclude the physical survey findings.
Results: The average age of patients was 43 years and 298 breast lesions were detected after clinical examination and imaging methods, distributed in 80% solids nodules an 20% cystic. In the Sensifemme device group sensitivity was 68,1%, specificity was 58% and the accuracy was 66,7%. In the clinical examination group was 54%, 78% and 57,4%. The Sensifemme glove has increased the diagnosis of breast lesions by 14,9% and there wasn’t interobserver variability. The difference between the clinical examination and examination with Sensifemme device was statistically significant (chi-square test 33.97 and value p<0.001) and the glove efficacy was higher on the nodules with less than 1.0 cm and in a skin distance 0.5 cm. The concordance of the clinical examination and Sensifemme device with ultrasonography was weak, with kappa index of 0.15 and 0.16, respectively.
Conclusion: The Exam made with Sensifemme device was more effective in the diagnosis of breast nodule than insolated clinical examination, facilitatating the detection of breast lesions and increasing the sensitivity and accuracy of the physical examination.
Institution: Paulista School of Medicine from São Paulo Federal University (EPM-UNIFESP) -SP
STUDY 3. GOVERNAMENTAL PROGRAM FOR THE DELIVERY OF SELF EXAMINATION GLOVE
In 2004 a Program in Mexico took place, concretely in the Azcapotzalco Delegation where gloves of breast self-examination were given to 267º women with the main objective of encouraging the breast cancer prevention. The purpose was that women develop in an early age a prevention culture with the help of the breast self-examination glove.