Long-term scarring outcomes and safety of patients treated with NovoSorbⓇ Biodegradable Temporizing Matrix (BTM): An observational cohort study.

Background/Aim: NovoSorbⓇ Biodegradable Temporizing Matrix (BTM) is a relatively novel, biodegradable polyurethane-based dermal regeneration template. The aim of this study was to evaluate the long-term scarring outcomes and safety of BTM in patients who underwent dermal reconstruction involving ≥5% of the total body surface area. Methods: This was a postmarket, multicenter, observational cohort study involving evaluation of long-term outcomes in patients treated with BTM. A total of 55 patients (35 from Royal Adelaide Hospital, South Australia, and 20 from Victoria Adult Burns Service, The Alfred, Victoria) who underwent dermal repair with BTM between 2011 and 2017 were screened for inclusion in this study. All patients had BTM implanted for ≥18 months. Results: Fifteen eligible patients with a mean (SD) age of 49.1 (14.3) years completed study assessments. These patients had a total of 39 areas treated with BTM. Using the Patient and Observer Scar Assessment Scale, scar quality was reported to be good by both observers and patients, with a mean (SD) observer score across all lesions of 3.6 (1.2) and mean (SD) overall opinion of 3.8 (1.2) as well as a mean (SD) patient score of 3.5 (1.2) and overall opinion of 5.0 (2.2). No adverse events or adverse device effects were reported or identified. Conclusion: The long-term scar quality is comparable to published studies. BTM is safe in the long term with no additional risks or adverse consequences being identified.

Organ donor screening using parallel nucleic acid testing allows assessment of transmission risk and assay results in real time.

Expansion of the donor pool may lead to utilization of donors with risk factors for viral infections. Donor laboratory screening relies on serological and nucleic acid testing (NAT). The increased sensitivity of NAT in low prevalence populations may result in false-positive results (FPR) and may cause unnecessary discard of organs.We developed a screening algorithm to deal, in real time, with potential FPR. Three NAT assays: COBAS AmpliScreen assay (CAS), AmpliPrep Total Nucleic Acid Isolation/CAS, and AmpliPrep/TaqMan assays, were validated and used in parallel for prospective screening of increased-risk donors (IRD), and the probability of FPR was calculated. The lower limit of detection of this algorithm was 9.79, 21.02, and 4.31 IU/mL for human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus, respectively, with an average turn-around-time of 7.67 h from sample receipt to result reporting. The probability that a donor is potentially infectious with two NAT concordant results was >90%. NAT screening of 35 IRD within 18 months resulted in transplantation of 102 additional organs that without screening would either not be used or used with restrictions in Australia. Using a parallel testing algorithm, real-time confirmation of seropositive donors allows use of organs from IRD and safer expansion of the donor pool.

Transport of microsporidium Encephalitozoon intestinales spores in sandy porous media.

The retention and transport of microsporidium Encephalitozoon intestinales spores in two water-saturated sandy porous media was investigated in this study. The initial breakthrough of the spores in the column effluent occurred essentially simultaneously with that of a non-reactive tracer, indicating no significant velocity enhancement. A large fraction (45-73%) of the spores injected into the columns was not recovered in the effluent, indicating removal from solution through colloid retention processes of attachment and/or straining. The relative significance of attachment and straining to total retention was evaluated in additional experiments. An experiment was conducted with a sieved coarse fraction of porous media for which straining is unlikely to be of significance based on the relative diameters of the spores and porous-medium pores. The spore recovery for this experiment was similar to the recoveries obtained for microsporidia transport in the un-sieved parent porous medium. An additional experiment was conducted with a subsample of the coarse fraction that was acid-washed to reduce potential surface attachment sites. Spore recovery was complete for this experiment. These results suggest surface deposition was the primary removal mechanism in our system. This conclusion is supported by the results of an experiment wherein deionized water was flushed through a column that was previously flushed with electrolyte solution. The effluent spore concentrations were observed to increase upon injection of deionized water, indicating re-mobilization of spores upon a change in water chemistry. The measured data were successfully simulated using a mathematical model incorporating colloid filtration. The results of this study suggest that the transport of microspordia in sandy porous media is governed by established colloid-transport processes.

Exposure to hepatitis A virus among blood donors, injecting drug users and prison entrants in Victoria.

To assess prevalence of exposure to hepatitis A virus (HAV) among injecting drug users (IDUs) and prison entrants in Victoria, and to compare this with prevalence of HAV among a reference population of blood donors, sera stored from two previous studies and from randomly selected blood donors were tested for total antibody to HAV. The first study was a longitudinal study of field-recruited IDUs from 1990 to 1992 and the second was a study of all prison entrants in 1991-92 (both studies were carried out in Victoria); blood donors were from the Australian Red Cross Blood Bank Victoria in 1995. Forty-five per cent of 2175 prison entrants and 51% of 293 IDUs were seropositive for HAV, compared with 30% of 2995 blood donors. When standardized for age against the blood donors, HAV seropositivity in IDUs was 44% and in prison entrants 60%. The strongest association of HAV seropositivity among the IDUs on multivariate analysis was a history of imprisonment. There are high rates of exposure to HAV among prison entrants, whether with a history of IDU or not, and among IDUs who have a prison history. The role of sharing contaminated injecting equipment in transmission of HAV seems to be less important than institutionalization per se. With adequate resourcing, both populations are appropriate targets for HAV vaccination, especially in a context of continuing decline of transmission of HAV in the general community.

Evaluation of blood donors with equivocal hepatitis C serological results.

OBJECTIVE: To characterise blood donors with equivocal hepatitis C serological results and to develop an algorithm for their diagnosis and follow-up. DESIGN: Prospective case survey. SUBJECTS AND SETTING: 100 consecutive blood donors referred to the St Vincent's Hospital Liver Clinic, Victoria, with equivocal hepatitis C serological results (positive result for second generation Abbott Enzyme Immunoassay 2.0, but at least one negative result on supplemental testing by first generation Abbott neutralisation assay and Abbott Supplemental Assay for antibody to specific viral antigens). OUTCOME MEASURES: Percutaneous risk factors for hepatitis C exposure, peak serum alanine aminotransferase (ALT) levels, results of alternative immunoassay (Monolisa) and polymerase chain reaction (PCR) to detect hepatitis C viraemia. RESULTS: Thirty subjects had positive results for alternative immunoassay. A risk factor was identified for 32 subjects and was significantly associated (P < 0.01) with positive results for alternative immunoassay (23/32) and PCR (11/32), abnormal ALT levels (7/32), and strong reactivity on initial immunoassay (23/32). Presence of antibodies to both structural and non-structural antigens was also associated with risk factors and positive alternative immunoassay results. CONCLUSIONS: A definitive diagnosis was possible in 87% of subjects. A diagnosis of hepatitis C infection was based on positive alternative immunoassay results together with positive PCR results or presence of a risk factor. Hepatitis C was excluded for 60% of patients. The diagnosis for the remaining 13% remained indeterminate, indicating the need for a definitive diagnostic test for hepatitis C.

Risk factors and predictors of outcome in an Australian cohort with hepatitis C virus infection.

OBJECTIVES: To define demographic and epidemiological features of an Australian population with chronic hepatitis C virus (HCV) infection and determine predictors of histological and clinical outcome. DESIGN: Cohort study. PATIENTS AND SETTING: 342 consecutive HCV antibody-positive patients referred to the liver clinic of a major metropolitan general hospital. OUTCOME MEASURES: Demographic data, serial alanine aminotransferase (ALT) levels, full blood count for all patients. Percutaneous liver biopsy in 152 patients (44%). RESULTS: 51% of patients had previously used injecting drugs, 15% had received a blood transfusion and 27% had no definite percutaneous risk factor (sporadic group). The injecting drug users (IDUs) were younger and more likely to have been born in Australia. The sporadic group were older and frequently were born in Mediterranean or Asian countries. A history of excessive alcohol use was common, particularly among IDUs (60%). Of 152 patients who had a liver biopsy, 49 had cirrhosis and 103 had chronic hepatitis. Some patients with a normal ALT level had marked necro-inflammatory activity. On univariate analysis, the presence of cirrhosis correlated with older age (P < 0.0001), lack of an identifiable risk factor (P < 0.001) and birth in a Mediterranean or Asian country (P < 0.0001). On multivariate analysis, the only significant predictor of cirrhosis was age (P < 0.001). Among patients with an identifiable percutaneous risk factor, cirrhosis was seen at a median time of 18 years after first exposure to risk, compared with 13 years in patients with chronic hepatitis (P < 0.01). Patients with clinical evidence of portal hypertension were, on average, 15 years older than those with histological cirrhosis only (P < 0.01). CONCLUSIONS: Injecting drug use is the major risk factor for chronic HCV infection in Australia. In patients with an identifiable risk factor, the most significant factor associated with a biopsy finding of cirrhosis is the time since first exposure to HCV.

Comparative bioavailability of ferric polymaltose and ferrous sulphate in iron-deficient blood donors.

Absolute iron deficiency is treated by correcting the causative lesion and then, traditionally, administering sufficient amounts of ferrous salt to return the haemoglobin level to normal and replenish body stores. The bioavailability of ferric compounds has been questioned and accordingly their therapeutic role remains controversial. A special problem is posed by regular blood donation, where the frequency of phlebotomy is limited by the haemoglobin level, which, in turn, requires maintenance of an adequate supply of iron from dietary sources. Since this latter situation may not always occur, it would be of practical benefit to have a form of supplementation that is effective and can be taken without side effects. These issues were prospectively examined in a consecutive series of otherwise healthy blood donors who developed absolute iron deficiency anaemia and were then randomly allocated to receive 60 mg of this metal as ferrous sulphate twice a day (Group 1: n = 51), 100 mg as chewable ferric polymaltose daily (Group 2: n = 53), or the latter product twice a day (Group 3: n = 55). Serial studies showed that 80% of patients in Groups 1 and 3 had reached normal haemoglobin levels by 12 weeks, but this figure was only 50% in Group 2. Similarly, the proportion of patients improving their percentage saturation of transferrin to within the normal range was significantly better in Groups 1 and 3 than in Group 2 (P < .01). However, body iron stores, reflected in serum ferritin level, was significantly better in Group 1 (P < .01); there was no difference in this respect between Groups 2 and 3.(ABSTRACT TRUNCATED AT 250 WORDS)

Method for the safe and rapid pretransfusion warming of stored blood: an in vitro and in vivo evaluation of a radiofrequency (RF) instrument.

Inadvertent hypothermia due to massive infusion of stored blood can be prevented by pretransfusion warming. One approach is the heating of individual packs by means of electromagnetic conduction, which is a method safely used over the last 25 years. The prototype instrument, which has now been re-engineered, can effectively raise the temperature of a unit of blood to approximately 33 degrees C in less than 3 minutes. Using this new model, we found, in vitro, a modest increase in free plasma haemoglobin, but this was not accompanied by any change in potassium or lactic dehydrogenase levels and the mean red cell fragility was unaltered. In vivo, the survival of autologous red cells that had been stored for 33 days and then infused as a concentrate, having a mean haematocrit of 0.60, was measured at 24 hours and 21 days. Each donor acted as his own control. In paired studies, pretransfusion radiofrequency heating was shown to have no deleterious effect when compared to measurements using the unwarmed blood pack. It is concluded that this method can be recommended as safe.

Prediction of hepatitis C virus infectivity in seropositive Australian blood donors by supplemental immunoassays and detection of viral RNA.

The prevalence of anti-hepatitis C virus (HCV) enzyme immunoassay (EIA)-positive in 167,511 Australian volunteer blood donors from Adelaide, Melbourne, Perth, and Sydney was 0.78%. One thousand two-hundred and eighteen EIA-positive serum samples were assessed by supplemental tests including a blocking EIA and two peptide EIAs corresponding to major epitopes of the HCV C-100-3 antigen. Seven hundred and eighteen samples (59%) were negative by supplemental testing; no evidence of reactivity with other HCV gene products or HCV RNA detected by cDNA polymerase chain reaction was found in selected samples from this group. In contrast, of 43 samples randomly selected from 400 samples (32.8%) positive by supplemental testing, 88% were reactive with HCV 33-C or core antigens and 52% contained HCV RNA, suggesting contact with HCV and infectivity of most donors in this group. Most samples equivocal by supplemental testing reacted only with C-100 and not with other HCV antigens when tested by dot immunoblot assay. Only 21% had detectable HCV RNA. The battery of assays used in this study indicated that approximately 32% of HCV EIA repeatably reactive serum samples were serologically related to HCV, corresponding to a 0.25% prevalence of potentially infectious donors.

Testing of saliva for antibodies to HIV-1.

To determine whether saliva is a potentially useful sample for screening for HIV infection when serum is not obtainable, saliva and serum samples from 50 HIV-infected and 50 uninfected subjects were tested for antibody to HIV-1 (anti-HIV-1) using a second-generation enzyme-linked immunosorbent assay (ELISA; Abbott) and prototype antibody-capture ELISA (Wellcome). Of saliva specimens from HIV-infected people, six gave negative results on the Abbott and one on the Wellcome assays; all specimens from uninfected people were negative by both assays. Sensitivity for the Abbott assay was therefore 88.0% [95% confidence interval (Cl) 76.2-94.4%], an unacceptable level for screening purposes. Sensitivity for the Wellcome assay was 98% (95% Cl 89.5-99.6%), a more satisfactory level for population screening. Further validation of this technique is necessary, and of methods for collection of saliva specimens in particular.

In vitro study of immunologic changes in long-term cytapheresis donors.

Several in vitro measurements of immune function were examined retrospectively in a population of active long-term cytapheresis donors (group I; n = 50) and the results were compared to age- and sex-matched controls (group II; n = 50) who had donated only whole blood. In group I, significantly different mean absolute lymphocyte counts (P = .0025), total T-cells (P = .0026) and T-helper cells (P less than .0001), and helper-to-suppressor ratios (P = .0279) were present. No differences were noted between the two groups for peripheral blood mean B-cell count, T-suppressor numbers, lymphocyte responsiveness to mitogens or alloantigen, and serum immunoglobulin level. The reduced mean absolute lymphocyte count in group I was due to the reduction in T-helper cell numbers and accounted for the imbalance in the helper-to-suppressor ratio. These disturbances are currently unexplained and, while no clinical consequences have so far become evident, there is a need to continuously monitor the immunologic status of cytapheresis donors. It is also important to determine whether reversal of the defects occurs and, if so, over what time interval.

Kaposi's sarcoma, tuberculosis and Hodgkin's lymphoma in a lymph node--possible acquired immunodeficiency syndrome. A case report.

A patient in whom a single lymph node contained Kaposi's sarcoma, tuberculosis and Hodgkin's lymphoma is reported on. Kaposi's sarcoma was also present in the skin of the legs, and serum antibody titres to cytomegalovirus were elevated. This case may represent acquired immunodeficiency syndrome in a Black South African male.

Contraception after abortion.

PIP: A study conducted among patients of a Washington, D.C. clinic to examine acceptance of contraception at the time of abortion and its use 6 months afterwards is described. Of 303 women who obtained abortions in the clinic in January 1972 and were interviewed about 6 months later, 93% chose a method of contraception at the time of abortion and 91% were using contraception at the time of follow-up. 86% chose the pill or IUD at the time of abortion and 78% were protected by the pill, IUD, or sterilization 6 months after the abortion. Although 1/4 of the women changed methods during the 6-month period after the abortion, the vast majority were highly persistent in using effective methods of contraception. It is noted that since 8 of 10 women had used contraception at some time before the abortion, caution must be taken in attributing the high prevalence of use following abortion to the experience of pregnancy and abortion. However, it is also pointed out that only 56% of the single teenagers had used any method of contraception at any time before their abortion, but 88% were using a method when interviewed 6 months after the abortion, and 74% of them were using the pill or IUD. These data suggest that the experience of becoming pregnant and obtaining an abortion in a clinic which offers contraceptive counseling and services leads to increased use of contraception, especially of the more effective methods.^ieng