The use of a surgical assist device to reduce glove perforations in postdelivery vaginal repair: a randomized controlled trial.
OBJECTIVE: Our purpose was to compare the effectiveness of a surgical assist device, SutureMate, to decrease glove perforations during postdelivery vaginal repair. STUDY DESIGN: This was a prospective randomized trial. After delivery surgeons who needed to perform vaginal repair were randomized to use the surgical assist device or to perform the repair in the usual fashion. After the repair, gloves were collected and the operator was asked to complete a standardized data form that was submitted with the gloves. The gloves were tested for perforations within 24 hours by the Food and Drug Administration-approved hydrosufflation technique. Comparisons were made with chi(2) statistics with p < 0.01 taken as being statistically significant with the use of a Bonferoni adjustment for multiple comparisons. RESULTS: A total of 476 glove sets were evaluated. The use of the surgical assist device significantly reduced the overall glove perforation rate from 28.3% in the control arm to 8.4% in the study arm (p = 0.0001). Rates of perforation varied with level of training and expertise but fell in all groups that used the device. Family physicians had the highest perforation rate in the control arm and benefited most from the device. A total of 76% of perforations were located in the thumb, index, and second fingers of the nondominant hand. Perforations were recognized in only 16% of the glove sets. The level of satisfaction with the device was mixed, but overall 50% of operators indicated that they were either satisfied or very satisfied with the device. CONCLUSION: The rate of glove perforation in postdelivery vaginal repair is high. The surgical assist device significantly reduced the rate of glove perforations.