We aimed to compare the outcome of two different operative methods to correct pilonidal sinus disease (PSD) in children, i.e., excision and open wound care (OW) versus excision and primary transverse closure (PC) of the wound. In this retrospective, observational study, we extracted data from the medical records of 56 patients who underwent surgery for PSD at our institution between 1 January 2006 and 31 December 2016. To test whether the primary variable, i.e., rate of PSD recurrence, differed between the two surgical groups, a logistic regression model was fitted. Secondary explanatory variables were total length of stay (LOS) at the hospital, complications, sex and age of patients, seniority of the surgeon in charge, and volume of excised specimen. Overall, 32 (57%) children and young adults underwent OW, while 24 (43%) patients were treated by PC. Mean age at operation was 15.5 years in either group. PSD recurred in 12 of 32 (37.5%) children in the OW group and in 3 of 24 (12.5%) children in the PC group (ratio: 0.19, 95% confidence interval [95% CI] 0.03–1.07). Thus, treatment of primary PSD by PC proved superior with respect to PSD recurrence. Moreover, our study did not bring to light any high-grade complications in the PC group, and postoperative pain was minimal. Less invasive treatment approaches for chronic PSD are typically performed in an outpatient setting and offer reduced morbidity, low rates of PSD recurrence, and shortened periods of time to return to work or social activities. More radical operations of PSD should be reserved for recurrent PSD where less invasive approaches have failed several times.
To examine the safety and acceptance "Vibwife", a new moving mattress to support mobilization of pregnant women during labor. The study was a prospective medical device clinical study without a control group. The study was designed in intervention phases, with safety evaluation by a safety review board after each intervention phase. The study took place at the University Hospital of Basel, Switzerland. 50 women were included with a low risk singleton pregnancy > 37th weeks during the first stage of labor. Evaluation of the safety and acceptance of women, midwives and physicians during the first stage of labor. The intervention was carried out in 3 phases. In the first phase five women in labor used the device for 10 minutes, the next 10 women for 20 minutes, and finally the next 35 women for 30 minutes. Measurement included capturing Adverse Events (AEs) (including Adverse Device Effects (ADEs)), Serious Adverse Events (SAEs) and recording vital parameters before, during, and after intervention, as well as CTG before and after intervention. Acceptance by women, midwives and physicians was measured by questionnaires with a 4-point Likert scale and pain intensity by a discrete Visual Analogue Scale (VAS) from 0-10. No SAE occurred during the trial. A total of 32 AEs occurred in 25 women during the intervention or in the 30 minutes follow-up. The most frequently observed AEs were modification of blood pressure and CTG abnormalities. None of the 32 AEs led to sequels of any kind. The relationship between AEs occurrence and the use of the medical device was viewed as certain in 2 cases (6.2%), possible or likely in 8 cases (25%), and unlikely or unrelated in 22 cases (68, 7%). Overall, women, midwives and physicians reported high satisfaction with their use of the device. The medical device "Vibwife" was judged as safe for women. Acceptance among women and health personnel was good. Considering the potential benefits of mobilization during labor, this new medical device could be a very interesting adjunct to other obstetrical tools. Particularly, women whose mobility is restrained by epidural anesthesia while giving birth could be very suitable candidates. To answer the question of efficacy, a randomized-controlled trial is required.