Search

Background. Topical hemostats reduce blood loss and optimize patient outcome and health care costs. The choice of agent depends on mode of action and surgical situation. This post-market clinical study evaluated the safety and effectiveness of Surgicel®-P, a powdered form of oxidized regenerated cellulose, designed to help control mild-to-moderate bleeding on broad or raw tissue surfaces.Methods. In a prospective, single-arm, multicenter trial, adult subjects with a target bleeding site (TBS) (mild-to-moderate bleeding for which conventional hemostatic methods were impractical or ineffective) were treated with Surgicel®-P. The primary endpoint was the proportion of subjects showing hemostasis at 5 minutes after application, without re-bleeding needing other hemostatic treatment. Secondary endpoints were these proportions at 3 and 10 minutes. The investigators’ ease-of-use evaluation of Surgicel®-P was recorded via questionnaire. Safety endpoints were the incidences of re-bleeding and thromboembolic events through day 30, and serious adverse events requiring surgical intervention through month 6 with a causal (including unlikely or at least possible) relationship to Surgicel®-P. Results. In 8 centers, 103 subjects were enrolled [median(range) age 64.0(33-88) years], of which 100 completed the study. Two deaths occurred, due to causes unrelated to Surgicel®-P. Surgeries were open (53.4%) or laparoscopic/thoracoscopic (46.6%), and mostly urological (37.9%) and abdominal (32.0%); TBSs included various tissue types, with mild (69.9%) or moderate (30.1%) bleeding over a median(range) surface area of 4(0.02–72.0) cm2. The 5-minute hemostatic success rate (primary endpoint) was 87.4%; the 3- and 10-minute rates (secondary endpoints) were 77.7% and 92.2%, respectively. Subgroup analyses showed 3-, 5- and 10-minute rates of 84.7%, 93.1%, 95.8% for mild, versus 61.3%, 74.2%, 83.9% for moderate bleeding, and 80.0%, 90.9%, 96.4% for open versus 75.0%, 83.3%, 87.5% for laparoscopic/thoracoscopic procedures. Within 10 minutes, initial manual compression (27.5%) was progressively abandoned, and additional Surgicel®-P was applied to 17.4% of TBSs. Investigators reverted to suture, cautery or other topical hemostats in 6.8% of procedures. No safety signals were identified. Investigators favorably evaluated the ease of use of Surgicel®-P device. Conclusions. This post-market clinical study supports the safety and efficacy of Surgicel®-P in controlling mild-to-moderate surgical bleeding in a broad range of surgical procedures.Clinical Trial Registration number. NCT03762200, 03/12/2018

IntroductionThe standard treatment of ovarian cancer is the combination of debulking surgery and chemotherapy. There is an ongoing discussion on which treatment is best: primary debulking surgery (PDS) or neoadjuvant chemotherapy with interval debulking (NACT-IDS). Even a large randomized trial has not settled this issue. We examined whether comparing a specified treatment protocol would not be a more logical approach to answer this type of discussions.MethodsA retrospective study of 142 consecutively treated patients according to a fixed protocol between 2000 and 2012 was conducted. Disease-free survival and overall survival were calculated by univariate and multivariate analyses for the whole group and for advanced stages separately. Specific differences between PDS and NACT-IDS were studied. Comparison of results from large databases was made.ResultsDisease-free survival and overall 5-year survival for the whole group were 35% and 50%. For the advanced stages, disease-free survival and overall 5-year survival were 14% and 36%, with a median disease-free and overall survival of 16 and 44 months. Of the 98 women with advanced ovarian carcinoma, 54% of operable patients underwent PDS and 44% underwent NACT-IDS. More patients in the PDS group were optimally (DiscussionOutcome of treatment according to a fixed protocol with a mixture of PDS and NACT-IDS was similar to results from large databases. We hypothesize that comparison of a specific strategy may yield more useful results than awaiting the perfect randomized trial.

This chapter reviews the three major issues relevant to getting started with a home-based medical service. They are (1) defining the clinical and geographic aspects of a target population, (2) how to build a practice and team structure for a defined population, and (3) what are the financial options for long-term sustainability. Building an effective and sustainable home-based medical practice depends on creating a dedicated core team to deliver comprehensive medical and social services focused on avoiding high-cost events, successful integration of community service partners, establishing a strong administrative structure, and a diversified financial model.