Reduction of central venous line-associated bloodstream infection rates by using a chlorhexidine-containing dressing.

PURPOSE: The reduction of central venous line (CVL)-associated bloodstream infections (CLABSIs) is generally advocated. However, despite implementing infection prevention recommendations, CLABSI rates remain high at some institutions. Therefore, a chlorhexidine-containing dressing should be assessed for its potential for infection reduction, adverse events (AEs) and practicability. METHODS: The number of CVLs, CVL days, CLABSIs and CLABSI rates with regard to the kind of dressing (standard vs. chlorhexidine-containing) were documented from November 2010 to may 2012 (1,298 patients with 12,220 CVL days) at two intensive care units (ICUs) and compared to historical controls. The practicability and safety of the chlorhexidine-containing dressing and reasons for not using this dressing were assessed. RESULTS: Forty CLABSIs occurred in 34 patients, resulting in a significantly lower overall CLABSI rate in patients with the chlorhexidine-containing dressing [1.51/1,000 CVL days; confidence interval (CI): 0.75-2.70] compared to patients with the standard dressing (5.87/1,000 CVL days; CI: 3.93-8.43; p < 0.0001). The CLABSI rate in historical controls receiving the standard dressing was 6.2/1,000 CVL days. The main reason for not using chlorhexidine-containing dressing was bleeding at the insertion site. AEs occurred in five patients and represented self-healing skin macerations (3 cases) and superficial skin necrosis (2 cases). CONCLUSIONS: In case of high CLABSI rates despite the implementation of standard recommendations, our findings suggest that a chlorhexidine-containing dressing safely decreases CLABSI rates.

Influence of aortic dimensions on the hemodynamic performance of small aortic valve prostheses: impact on patient/prosthesis mismatch.

BACKGROUND: Since Doppler echocardiography takes no account of pressure recovery, the true hemodynamic burden of aortic valve prostheses remains vague. The purpose of this study was to elucidate the methodological error of Doppler gradient estimation by means of a model demonstrating the different influence of aortic root diameters on net and Doppler gradients, respectively. This matters especially in small valves and the related patient/prosthesis mismatch calculation. METHODS: Two bileaflet small aortic valve prostheses (19 mm SJM Regent® and On-X® valve) were tested using a pulsatile circulatory mock loop simulator with two different aortic models: one with statistically normal diameters according to annular size, another one simulating an aortic aneurysm of 50 mm. Doppler and simultaneously recorded net gradients as well as systolic energy losses were obtained for different hemodynamic conditions. RESULTS: In all measurements a significant amount of pressure recovery was observed. In cases of aortic aneurysm systolic energy loss increased significantly for each cardiac output at each heart rate ( P < 0.0028), reflected by a significant ( P < 0.0001) increase in net gradients. The corresponding Doppler gradients were unchanged. This indicates significantly less pressure recovery ( P < 0.0001) in the aneurysmatic aorta. CONCLUSIONS: Geometry of the ascending aorta considerably alters aortic valve hemodynamic parameters. The hemodynamic function of small aortic valve prostheses, especially with corresponding normal outflow dimensions, is much better than expected from Doppler gradients. Thus, calculation of a patient/prosthesis mismatch can be misleading.

[Anaylsis of the surgeon factor in the treatment results of rhegmatogenous retinal detachment in the "scleral buckling versus primary vitrectomy in rhegmatogenous retinal detachment study"]. / Einfluss des Operateurs auf die Operationsergebnisse bei rhegmatogener Ablatio retinae im Rahmen der "Scleral Buckling versus Primary Vitrectomy in Rhegmatogenous Retinal Detachment Study".

BACKGROUND: The effect of the surgeon on the outcome of surgical treatment for rhegmatogenous retinal detachment (RRD) has previously been analysed in a few studies only. In the prospective multicentre SPR study, scleral buckling (SBS) and primary vitrectomy (PV) were compared in RRD with medium complexity in a randomised fashion. In this study, we examined the surgeon factor on the outcome of RRD surgery within the SPR study. MATERIAL AND METHODS: An analysis of the surgeon as a factor on the functional outcome (logMAR visual acuity), primary anatomic success (retinal reattachment central to the aequator without any additional retina-affecting surgery including laser, cryo and macular pucker surgery) and final anatomic success (retinal reattachment one year postoperatively) was carried out. RESULTS: Overall, 416 phakic patients (209 SBS, 207 PV) and 265 pseudophakic patients (133 SB, 132 PV) were recruited by 45 surgeons in 25 centres. In the phakic group, the mean functional outcome of individual surgeons was between 0.2 and 0.74 (mean, 0.41, SD 0.41). This difference reached statistical significance (p = 0.0398). In the pseudophakic subgroup, the mean functional outcome was between 0.09 and 0.64 (mean, 0.42, SD 0.49) without reaching a statistical significance (p = 0.0715). Primary success per surgeon varied between 41.67 % and 90.00 % (mean, 63.16 %) in the phakic subgroup and 33.33- 80.95 % (mean, 61.75 %) in the pseudophakic subgroup. Final anatomic success was achieved in 92.86 - 100.00 % (mean, 97.96 %) in the phakic subgroup and 80.00 - 100.00 % (mean, 95.44 %) in the pseudophakic subgroup. There was no statistically significant correlation between surgeon and anatomic outcomes. CONCLUSION: In the phakic subgroup, a statistically significant correlation between surgeon and functional success could be demonstrated for RRD with medium complexity. This correlation was not interrelated to the surgical method. Functional outcome in pseudophakic patients and anatomic outcomes in both subgroups of phakic and pseudophakic patients showed no statistically significant correlation between surgeon and anatomic success.

[Primary pars plana vitrectomy. Techniques, indications, and results]. / Primäre Pars-plana-Vitrektomie. Techniken, Indikationen und Ergebnisse.

The choice of primary vitrectomy as the first treatment method for rhegmatogenous retinal detachment has grown in popularity over recent years. The main reason behind this trend is the improved control of more complicated situations of retinal detachment. However, clinical trials comparing primary vitrectomy with scleral buckling had failed to demonstrate an advantage of this method regarding anatomical and functional results. The Scleral Buckling Versus Primary Vitrectomy in Rhegmatogenous Retinal Detachment Study (SPR study) is a prospective, randomised, multicentre study comparing primary vitrectomy with or without additional scleral buckling to scleral buckling alone. Overall, 681 patients with more complicated retinal detachments were recruited in 25 centres. In the phakic subgroup of patients, an advantage regarding the main endpoint (change in visual acuity) was found in the scleral buckling group. In the pseudophakic subgroup, no difference in functional outcome could be seen; however, better anatomical results with a lower rate of retina-affecting reoperations was observed in the vitrectomy group, with particularly good results in the subgroup of patients receiving vitrectomy and additional scleral buckling. Based on the available data, primary vitrectomy combined with a scleral buckle is the method of choice in more complicated types of retinal detachment in pseudophakic patients. In contrast, primary vitrectomy does not seem to offer an advantage over scleral buckling in phakic patients.

Maxillary advancement versus mandibular setback in class III dentofacial deformity: are there any differences in aesthetic outcomes?

A retrospective evaluation of maxillary advancement and mandibular setback in class III patients was performed and their aesthetic outcomes compared. Patients with a sella-nasion-A-point angle (SNA) of 80-84° were selected. Pre- and postoperative lateral cephalograms were obtained for 34 class III patients; these were divided into two groups according to the surgical procedure performed: mandibular setback group (n=17) and maxillary advancement group (n=17). The pre- and postoperative cervical length, lip-chin-throat angle, lower/upper lip thickness, distance from the lower/upper lip to the aesthetic line, soft tissue angle, facial contour angle, and nasolabial angle of the two groups were compared. Significant differences were observed for cervical length (P=0.0003) and sex (P=0.003) when comparing maxillary advancement with mandibular setback. Although the preoperative cervical length was similar in the two groups, it increased significantly after maxillary advancement and decreased after mandibular setback. In this study, the differences in aesthetic outcomes depending on the surgical procedure performed were considered. Some aesthetically important parameters proved to be superior after maxillary advancement when compared to mandibular setback, even with the maxilla in the normal position.

Disinfection of gloves: feasible, but pay attention to the disinfectant/glove combination.

BACKGROUND: Compliance with hand hygiene is complicated by indications for hand disinfection in rapid succession during the care of one patient. In such situations, disinfection of gloves could facilitate better workflow and optimize compliance rates. AIM: We analysed the efficacy of disinfecting gloves by comparing an individual effect of five different hand disinfectant solutions in combination with three different glove types. METHODS: The investigation was performed in accordance with DIN EN 1500:2013. For all combinations, ten analyses were performed, including (1) right/left-hand examination disinfection efficacy after the first and fifth contamination with E. coli K12 NCTC 10538, (2) recovery rates after contamination, (3) reduction efficacy, (4) fingertip immersion culture, and (5) check for tightness. Disinfection of the ungloved hands was taken as an additional benchmark. FINDINGS: The disinfection efficacy for all disinfectant/glove combinations was better with rather than without gloves. For eight combinations, the disinfection efficacy was always >5.0 log10. There were significant differences within the gloves (P=0.0021) and within the disinfectant product (P=0.0023), respectively. In detail, Nitril Blue Eco-Plus performed significantly better than Vasco Braun (P=0.0017) and Latex Med Comfort (P=0.0493). Descoderm showed a significantly worse performance than Promanum pure (P=0.043). In the check for tightness, only the Vasco Braun gloves showed no leaks in all samples. There were relevant qualitative differences pertaining to the comfort of disinfecting gloves. CONCLUSION: The disinfection efficacy for the different disinfectant/glove combinations was greater than for the ungloved hands. However, various disinfectant/glove combinations produce relevant differences as regards disinfection efficacy.

Chemotherapy of drug-resistant ovarian cancer: a Southwest Oncology Group Study.

We present a final analysis, including pathology review, of a cooperative group study of drug-resistant ovarian cancer. Of 200 patients registered, 112 were eligible and evaluable, with a response rate of 26% and median survival of 7 months. Because these results are poorer than those reported in the preliminary and interim analyses of this study, we scrutinized the 88 excluded patients, most of whom failed to meet our strict pathologic criteria for a diagnosis of ovarian cancer of epithelial type, and who, as a heterogeneous group, fared better than patients who did meet the eligibility criteria. We believe this analysis provides insight into the spectrum of diseases that are frequently called ovarian cancer, but might be more properly labeled abdominal carcinomatosis.

Influence of venous drainage and hemofiltration on hypercirculatory instability after high volume crystalloid cardioplegia during coronary artery bypass surgery.

AIM: The etiology of hypercirculatory instability following cardiac surgery with cardiopulmonary bypass has not yet been completely investigated and its clinical impact remains unclear. This prospective study was undertaken in order to investigate the impact of the systemic infusion of high volume crystalloid cardioplegia on the incidence of hypercirculatory instability and inflammatory mediator release in patients undergoing coronary artery bypass grafting. METHODS: Forty patients with single-atrial cannulation (group A), 40 patients with single-atrial cannulation and intraoperative hemofiltration (group B), and 40 patients with bicaval cannulation and complete removal of the cardioplegic solution from the right atrium (group C) were analyzed for hemodynamic changes and inflammatory mediator release until the postoperative day 2. Myocardial protection was performed using 2,000 mL cold crystalloid cardioplegia. RESULTS: A higher incidence of hypercirculatory instability in group A (39.2%) and B (42.8 %) was noted when compared to group C (18%, P = 0.032). Cardiac index was lower in group C when compared with group A (P = 0.001; 95% CI: 4.1, 15.57) and group B (P = 0.02; 95% CI: 1.13, 15.25). Systemic vascular resistance was higher in group C when compared with group A (P = 0.0001; 95% CI: 7108.7, 3131) and group B (P < 0.005; 95% CI 7598.9; 2830.6). High levels of tumor necrosis factor alpha, interleukin-6, interleukin-8, interleukin-10, and intercellular adhesion molecule-1 with no significant differences between the groups were measured early postoperative. CONCLUSIONS: High volume crystalloid cardioplegia under use of single-atrial venous cannulation is associated with a higher incidence of hypercirculatory failure. Hemofiltration during cardiopulmonary bypass offers no benefit on the incidence of hypercirculatory instability and to the release of inflammatory mediators.

Good Medicine and Good Healthcare Demand Good Information (Systems).

The demand for evidence-based health informatics and benchmarking of 'good' information systems in health care gives an opportunity to continue reporting on recent papers in the German journal GMS Medical Informatics, Biometry and Epidemiology (MIBE) here. The publications in focus deal with a comparison of benchmarking initiatives in German-speaking countries, use of communication standards in telemonitoring scenarios, the estimation of national cancer incidence rates and modifications of parametric tests. Furthermore papers in this issue of MIM are introduced which originally have been presented at the Annual Conference of the German Society of Medical Informatics, Biometry and Epidemiology. They deal as well with evidence and evaluation of 'good' information systems but also with data harmonization, surveillance in obstetrics, adaptive designs and parametrical testing in statistical analysis, patient registries and signal processing.

Margins of oral leukoplakia: autofluorescence and histopathology.

Autofluorescence devices are widely used to examine oral lesions. The aim of this study was to see whether there were any signs of dysplasia, parakeratosis, or mucosal inflammation in the borders of homogeneous oral leukoplakia using autofluorescence, and we also compared clinically visible extensions with those detected by autofluorescence. Twenty patients with 26 homogeneous areas of oral leukoplakia were included in the study. After the clinically visible extensions of the lesion had been marked, we took a photograph through the autofluorescence device, which showed both borders in one picture. We then used photo-editing software to measure the size of the area of leukoplakia together with the area with loss of autofluorescence. We took 3 punch biopsy specimens: one from the leukoplakia, one 2.5mm from its marked borders, and one from healthy mucosa. Seventy-eight biopsy specimens were examined by an experienced pathologist, and 95% CI calculated to assess the amount of parakeratosis. Spearman's rank correlation was used to assess the association with mucosal inflammation. Ten areas of leukoplakia were surrounded by normal green autofluorescence, and 16 were consistent with loss of autofluorescence with a mean size of 66%, which exceeded the clinically visible size of the area of leukoplakia. We calculated that there was a strong association between these entities and their surrounding areas, with loss of autofluorescence for parakeratosis. Some leukoplakias showed clinically invisible extensions during histopathological examination and autofluorescence. The technique described enables clinicians to measure the extent of these lesions beyond their visible margins. We found no dysplasia, which emphasises that autofluorescence detects non-dysplastic lesions caused by mucosal inflammation and parakeratosis.

Slow axonal regrowth but extreme hyperinnervation of target muscle after suture of the facial nerve in aged rats.

Unilateral transection and suture of the facial nerve was performed in 60 old rats (20 months of age). The time course of mimetic reinnervation was studied by counting all retrogradely labeled motoneurons in the facial nucleus after injection of HRP into the whiskerpad muscles for 14-112 days post operation. The comparison between these neuron counts and data for young rats yielded four conclusions. First, the qualitative equivalent of the phenomenon "misdirected reinnervation" in aged rats was the same as in young adults: HRP-labeled motoneurons were scattered throughout the facial nucleus lacking myotopic organization from 18 until 112 days post operation. Second, no age-related loss of motoneurons was detected. Third, the axonal regrowth was delayed in aged rats. Fourth, the postoperative hyperinnervation (the projection of more motoneurons into a muscle than under normal conditions, i.e., the quantitative aspect of misdirected reinnervation) was more than two times higher than in young rats. These data may provide reasonable explanations for the poor functional recovery after reconstructive surgery on the facial nerve in old patients.

The Syed-Neblett interstitial template in locally advanced gynecological malignancies.

Twenty-eight patients with locally advanced malignancies of the cervix and vagina were treated with a combination of external radiation therapy and afterloading Syed-Neblett iridium template. There were 22 patients with squamous cell cancer and two patients with adenocarcinomas of the cervix. Four patients with squamous cell cancer of the vagina were treated with this method. Only patients with locally advanced disease (cervical lesion greater than 4 cm in diameter) and poor vaginal anatomy were selected for this modality of therapy. In our series the incidence of distant failures of 39% seems to confirm the significance of local volume of disease as a prognostic indicator; despite a local control rate of 59%, only 33% of our patients are alive from 25-51 months. Complications occurred in 12 patients (42%). Six patients (22%) developed severe rectal stricture or rectovaginal fistula necessitating diverting sigmoid colostomy; five patients (18%) developed hemorrhagic proctitis with diarrhea and tenesmus; one patient developed vaginal vault necrosis. Complications occurred 7 to 24 months following therapy. Six of the 12 patients developing complications are dead of disease. On the basis of this study and because of the low cure rate and high incidence of complications, the value of the Syed-Neblett template in locally advanced gynecologic malignancies should be reconsidered.

Improved in-stent magnetic resonance angiography with high flip angle excitation.

RATIONALE AND OBJECTIVES: To optimize the intraluminal signal intensity of a nitinol stent by performing contrast-enhanced three-dimensional magnetic resonance angiography (CE-MRA) with varying flip angles (FAs). METHODS: Contrast-enhanced magnetic resonance angiography at 1.5 T and FAs of 30 degrees, 100 degrees, and 150 degrees was performed on five sheep with 10 iliac nitinol stents (Memotherm-FLEXX). Maximum-intensity projections (MIPs) and composite images of MIPs were performed and compared. RESULTS: Reconstructed MIPs at an FA of 150 degrees showed a slightly disturbed lumen visibility inside the stent accompanied by low-grade lumen visibility outside the stent and vice versa for an FA of 30 degrees. Composite images of a 30 degrees MIP added to a 150 degrees MIP resulted in improved image quality compared with the standard MIP of a single FA. CONCLUSIONS: Signal loss due to radiofrequency shielding inside nitinol stents imaged by CE-MRA can be reduced by applying high FAs. Composite MIP images allow simultaneous visualization of the lumen inside as well as outside the stent.

Pelvic exenteration for vaginal embryonal rhabdomyosarcoma: a review.

The English language literature for the years 1935-1972 was reviewed to assess the effect of pelvic exenteration on vaginal embryonal rhabdomyosarcoma. Twenty-one cases were determined eligible for review. Tumor was confined to the vagina in 8 cases and extended beyond the vagina in 13 cases. Treatment by pelvic exenteration was found to be relatively ineffective means of curing patients with tumor extending beyond the limits of the vagina. Recent evidence from the literature indicates that better results can be obtained by coordinated treatment, ie, surgery, radiation therapy, and/or chemotherapy, than by surgery alone.

Ondansetron and metoclopramide fail to prevent vomiting secondary to ultra-high-dose cisplatin-carboplatin chemotherapy.

OBJECTIVE: To determine the severity of emesis caused by ultra-high-dose cisplatin-carboplatin chemotherapy and to compare the antiemetic efficacy of an ondansetron regimen and a metoclopramide regimen. METHODS: Forty consecutive patients with stage III or IV epithelial ovarian cancer or advanced or recurrent endometrial cancer were treated with ultra-high-dose cisplatin-carboplatin chemotherapy. No patient had received prior chemotherapy. Chemotherapy consisted of intravenous (IV) cisplatin 70 mg/m2 and IV carboplatin 100 mg/m2 administered on days 1 and 8 every 28 days for five cycles, representing a total monthly organoplatin dose of 207 mg/m2. Patients were randomized to receive metoclopramide, diphenhydramine, prochlorperazine, and lorazepam; or ondansetron, dexamethasone, prochlorperazine, and lorazepam. Patients were blinded and there was no crossover. The metoclopramide dose was 2 mg/kg IV every 2 hours x 3, and the ondansetron dose was 0.15 mg/kg IV every 4 hours x 3. RESULTS: All 40 patients developed vomiting; 21 (52%) developed severe vomiting and seven (17%) required home IV therapy (grade 4). Eight patients (40%) receiving the metoclopramide regimen developed severe vomiting, compared to 13 (65%) in the ondansetron group (P = .50). Two patients (10%) in the metoclopramide group developed grade 4 vomiting, compared to five (25%) in the ondansetron group (P = .45). Except for sedation and amnesia, there were no significant side effects associated with either regimen. CONCLUSION: Neither regimen was effective in preventing high-dose cisplatin-carboplatin-induced emesis, and the ondansetron regimen did not appear to be superior.

Meta-analysis of cisplatin, doxorubicin, and cyclophosphamide versus cisplatin and cyclophosphamide chemotherapy of ovarian carcinoma.

OBJECTIVE: To compare the survival with cisplatin, doxorubicin (Adriamycin), and cyclophosphamide versus that of cisplatin and cyclophosphamide in women with advanced epithelial ovarian cancer, to evaluate the effect of dose intensity, and to evaluate meta-analysis methodology. METHODS: Meta-analysis was done on 30 studies of 2060 women with stages III and IV epithelial ovarian cancer. All had 3-year survival data, adequate follow-up, no other chemotherapy, no radiation therapy, and had information for various prognostic variables (age, stage, grade, and residual disease). We used four different methods of meta-analysis: pooled published data and modified effect-size analyses of the entire group (30 studies), and pooled published data and effect-size analyses of the subset of five prospective randomized studies. RESULTS: Three-year survival for the entire group was 43% for cisplatin, doxorubicin, and cyclophosphamide versus 36% for cisplatin and cyclophosphamide; for the five prospective randomized studies, the rates were 46 and 35%, respectively. The survival advantage of cisplatin, doxorubicin, and cyclophosphamide was statistically significant when analyzed by the pooled published data and modified effect-size meta-analysis of the entire group and the pooled published data meta-analysis of the five prospective randomized studies. The effect-size meta-analysis of the five prospective studies did not reach statistical significance. Total dose intensity and doxorubicin dose intensity were not significantly associated with survival advantage in cisplatin, doxorubicin, and cyclophosphamide use. CONCLUSIONS: There seems to be a survival advantage to treatment with cisplatin, doxorubicin, and cyclophosphamide versus treatment with cisplatin and cyclophosphamide. We believe this to be due to the properties of multiagent chemotherapy (the addition of doxorubicin) rather than to increased dose intensity. In addition, we believe that physicians need to familiarize themselves with meta-analysis methodology.

Surgical staging and high dose rate brachytherapy for endometrial cancer: limiting external radiotherapy to node-positive tumors.

OBJECTIVE: To evaluate the efficacy and morbidity of surgical staging and high dose rate brachytherapy for women with stage I-IIIA endometrial cancer. METHODS: Sixty consecutive patients underwent surgical staging consisting of total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal cytology, bilateral pelvic lymphadenectomy, periaortic lymphadenectomy, and omentectomy. High dose rate brachytherapy was delivered postoperatively in three fractions for a total of 2100 cGy. Only patients with nodal metastasis received external radiotherapy. RESULTS: Twenty-two tumors (37%) were considered high-risk uterine disease because of deep invasion (stage IC), cervical involvement (stage II), positive peritoneal cytology (stage IIIA), or poor differentiation (grade 3). Lymph node metastases were detected in five patients. There was no surgical mortality, and morbidity from surgery and high dose rate brachytherapy was minimal. At a median follow-up of 3 years, there has been one recurrence. The conventional practice of postoperative external radiotherapy was altered in 23 of 60 patients (38%): 22 women with high-risk uterine factors did not receive external radiotherapy, and one patient with low-risk uterine factors (less than 50% myometrial invasion, grade 2) received external radiotherapy because of microscopic pelvic lymph node metastasis. CONCLUSION: Surgical staging and high dose rate brachytherapy without external radiotherapy for stage I-IIIA endometrial cancer were associated with minimal morbidity and produced excellent survival.

Particle concentration fluorescence immunoassay chemosensitivity assay for human epithelial ovarian cancer.

We adapted particle concentration fluorescence immunoassay technology to develop a new chemosensitivity assay. Six human epithelial ovarian cancer cell lines were incubated with cisplatin for 24 hours. Cells were then labeled with a fluorophore for 30 minutes. Removal of supernatant, washing of tumor cells, and reading of epifluorescence was performed automatically. Percent cell lysis was calculated simultaneously by chromium release assay. The particle concentration fluorescence chemosensitivity assay detected cell lysis in all six cell lines. The chemosensitivity assay detected a larger percent lysis than the chromium release assay in each of the cell lines. The advantages of our chemosensitivity assay are plating efficacy, speed, efficiency, safety, and accuracy.

Aggressive angiomyxoma of the vulva.

An unusual myxoid and vascular appearing neoplasm of the vulva, termed an aggressive angiomyxoma, is described in a 36-year-old Hispanic woman. The clinical presentation and recurrence pattern were typical for previously described neoplasms of the same cellular pattern. The histopathology, difficulties in determining the surgical margins, and the treatment of this tumor are discussed.

Adjunctive daunorubicin in the treatment of proliferative vitreoretinopathy: results of a multicenter clinical trial. Daunomycin Study Group.

PURPOSE: To assess the efficacy and safety of adjunctive daunorubicin during vitrectomy surgery in eyes with idiopathic proliferative vitreoretinopathy (PVR). METHODS: Two hundred eighty-six eyes (286 patients) with stage C2 (Retina Society Classification, 1983) or more advanced preoperative PVR in which surgery with silicone oil was planned were enrolled in a multicenter, prospective, randomized, controlled clinical trial. Standardized surgery plus adjunctive daunorubicin perfusion was compared with surgery alone. Outcomes assessed were retinal attachment without additional vitreoretinal surgery 6 months after standardized surgery, number of and time until vitreoretinal reoperations within 1 year of standardized surgery, and change in visual acuity 1 year after standardized surgery, evaluated by photodocumentation, number of reoperations, and measurement of best-corrected visual function. Outcomes were determined 6 months after operation and reevaluated after 1 year of follow-up. RESULTS: Six months after standardized surgery, complete retinal reattachment without additional vitreoretinal surgery was achieved in 62.7% (89/142) of eyes in the daunorubicin group vs 54.1% (73/135) in the control group (P = .07, one-sided). However, in the daunorubicin group, significantly fewer vitreoretinal reoperations were performed within 1 year postoperatively (P = .005, one-sided) to achieve the same overall 1-year retinal reattachment rate (80.2% [105/131] vs 81.8% [103/126]). The rate of patients with no vitreoretinal reoperations was 65.5% (95/145) in the daunorubicin group vs 53.9% (76/141) in the control group. There was no difference in the best-corrected visual acuity. No severe adverse effect related to daunorubicin was identified. CONCLUSIONS: Although the rate of anatomic success after 6 months failed to show significance, some benefit of the adjunctive treatment exists, especially a tendency toward increased rate of reattachment and a significant reduction in the number of reoperations. This shows that human PVR is amenable to pharmacologic treatment.