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BACKGROUND: Treatment of chronic wounds comprises adequate debridement, reduction in the bacterial burden, and application of a dressing to absorb excess exudate. METHODS: In a prospectively documented, multicenter observational study involving 1285 chronic wounds of varying etiologies, carried out in 314 doctor's offices in Germany, the effect of the new alginate dressing, containing calcium zinc and manganese was investigated. RESULTS: After twelve weeks of treatment with the dressing, 95% of all wounds had improved appreciably, and 52.5% had healed completely. The drop out rate was 4.4% and side effects were observed in 2.6% of the cases. 73.8% of the patients reported markedly improved tolerability in comparison with previous treatment. 604 patients (47.0%) considered handling of the dressing to be "much better", and 411 (32.0%) to be "better" than previous treatment. The frequency of dressing changes decreased from 5.2 to 3.2 a week.

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Skin substitutes in chronic wounds. There is a large demand for skin substitutes for the coverage of chronic wounds. Due to a intensive and local wound treatment the impaired dermal and epidermal repair still remains a major problem. Known treatmentes as split-skin-, reverdin- and pinch grafts make a sufficient and solid wound closure possible. However in such procedures the take rate of grafting often failes. The graft healing is increased with combined mesh-graft and vacuum-sealing technique. Temporary and permanent skin substitutes extend the spectrum in closure of chronic defects. Sheets and single cell suspensions of keratinocytes are available for clincial treatments. First clinical results with autologous keratinocyte transplantation are described. In the future approaches in gen therapy becomes more and more important for skin substitutes.

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A reliable reversed-phase high-performance liquid chromatographic method has been developed for the determination of terbinafine (Terb) and its desmethyl metabolite (DMT) in human plasma. The analytes and the internal standard (I.S.) are extracted by a liquid-liquid technique followed by an aqueous back-extraction, allowing injection of an aqueous solvent in the HPLC system. The mobile phase is acetonitrile + 0.012 M triethylamine -0.020 M orthophosphoric acid (50:50, v/v) and the UV detection is at 224 nm. The inter-assay precision over the concentration range 2-1000 ng/ml is between 2.9 and 9.8% for both compounds. The limit of quantification, 2 ng/ml for both compounds, is sufficient for investigating the pharmacokinetics of Lamisil in human studies. With an additional preparation step, this method can be used for assaying Terb in tissues such as nail, sebum and stratum corneum.

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The reaction of wounds up to 6 days old to the influence of six different temporary skin replacement materials was studied in rats. The histological work-up 1-7 days later showed material-dependent differences in wound reaction. The rate of adherence to the wound surface and the amount of granulation tissue, vascularization, and reepithelization was determinded. There is no ideal material; the special properties of each temporary skin substitute should be used according to the different surgical aims.

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A radioimmunoassay of cyclosporine (Sandimmune) involving use of a mouse monoclonal antibody was tested to monitor specifically the parent drug in plasma. The cyclosporine concentrations obtained by RIA were compared with those obtained by the HPLC method. For the RIA method, the within- and between-assay CVs are less than 6%, the limit of detection is about 10 micrograms/L for a 50-microL sample of plasma. For the HPLC method, the within- and between-assay CVs are less than 20%, the limit of detection is about 15 micrograms/L for a 1-mL sample of plasma. The concentrations by RIA correlated well with those by HPLC in samples from patients receiving bone-marrow (n = 39), heart (n = 52), or liver (n = 51) transplants. In all indications, the ratio of values by RIA to those by HPLC for these samples remained stable and close to 1 during the drug-monitoring period, i.e., for up to 202 days. Therefore, the specific RIA can be used instead of HPLC to measure the parent drug in plasma.

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DPI201-106 is a new positive inotropic agent. The cardiac electrophysiology of 16 patients was studied before and during DPI 201-106 administration (loading dose of intravenous DPI 201-106, 1.8 mg kg-1 h-1 administered over 10 min, followed by a maintenance dose of 0.2 mg kg-1 h-1). DPI 201-106 had no effect on the sinus node. The AH interval during fixed-rate atrial pacing became prolonged during DPI 201-106 infusion. There was a significant prolongation of the QT interval [QT (corrected), 417 +/- 22 to 502 +/- 35 ms, P less than 0.05; QT (atrial pacing at 600 ms), 374 +/- 17 to 419 +/- 23 ms, P less than 0.05; QT (ventricular pacing at 600 ms), 409 +/- 37 to 449 +/- 30 ms, P less than 0.05]. The ventricular effective refractory period significantly prolonged during DPI 201-106 administration (242 +/- 21 to 287 +/- 56 ms, P less than 0.05), but the supernormal-period duration decreased. The atrial effective refractory period was shortened in four patients and prolonged in one (261 +/- 67 to 240 +/- 53 ms, NS). The corrected atrial repolarization time (PTac) shortened significantly during DPI 210-106 infusion (479 +/- 26 to 445 +/- 22 ms at 20 min of the maintenance dose, P less than 0.05). Atrial fibrillation was initiated in five patients during DPI infusion, but no ventricular arrhythmia was provoked. These findings suggest that DPI 201-106 has novel differential electrophysiological effects on atria and ventricles.

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The pharmacokinetics of the cyclosporine A (CsA, Sandimmune) analogue Nva2-cyclosporine, or cyclosporine G (CsG) was investigated in 6 patients with terminal renal failure after a 4-hr intravenous infusion (3.5 mg/kg) and after oral administration (600 mg) of the drug. Blood samples were collected up to 38 hr and CsG concentrations were measured by radioimmunoassay and high-performance liquid chromatography. The resulting pharmacokinetic parameters of CsG were similar to those described for CsA in the same patient population. Based on HPLC determinations, a mean terminal elimination half-life of 18.9 hr was calculated. The total body clearance was 0.55 L/hr/kg, the volume of the central compartment was 0.32 L/kg, and the steady-state volume of distribution was 5.97 L/kg. After oral administration maximum CsG concentrations in blood were reached between 2.5 and 3 hr, and the bioavailability was in the range of 24-55% (mean 36%). The ratios between the polyvalent RIA and HPLC determinations were considerably larger after oral dosing than after i.v. infusion. The blood-to-plasma ratio was 1.23, which is smaller than that observed for CsA. These results suggest that in patients undergoing renal transplantation the same dosing strategies can be applied for CsG as have been established for CsA.

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A specific radioimmunoassay involving a mouse monoclonal antibody to cyclosporine has been developed for monitoring the parent drug in blood. Pretreatment with methanol removes cyclosporine from the erythrocytes. The limit of detection is about 12 micrograms/L, sample volume is 50 microL of blood, and within- and between-assay CVs are less than 7%. Assay results correlated well with those obtained by "high-performance" liquid chromatography (HPLC) for liver (n = 42), for heart (n = 64), for bone-marrow (n = 36), and for kidney (n = 140). For blood specimens obtained from patients treated with cyclosporine postoperatively for as long as 65 months, the mean RIA/HPLC ratio in all with transplant indications was close to 1. Therefore, the specific radioimmunoassay apparently can be used instead of HPLC to measure the parent drug in blood.

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A highly sensitive and specific column liquid chromatographic assay with electrochemical detection was developed for hydrolysed bopindolol, an active metabolite of bopindolol (Sandonorm) in human plasma. The pre-chromatographic sample preparation involved Extrelut column clean-up followed by liquid extraction of the organic extract into dilute acetic acid. Separation was on a Nucleosil ODS 3-microns column at 40 degrees C, with a phosphate buffer-methanol mobile phase. Detection was performed at +450 mV with an ESA electrochemical detector. Mepindolol was used as internal standard and quantitation was based on peak-area ratios. Total analysis time was 14 min per sample. The recovery rate of the assay was at least 70% for both compounds. A detection limit as low as 25 pg/ml, starting with 1 ml of plasma, was achieved. The day-to-day reproducibility and accuracy, checked with quality-control samples, demonstrated the reliability of this assay used by different analysts, on different chromatographic systems and over a long period of time.

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In an abrasion injury loss of tissue is combined with a marginal burn. The wounds should be primarily excised and adequately covered with a soft tissue flap. There may arise difficulties in evaluating the heat injury to the bone. The debridement of the bone should be completed by an early second-look operation to prevent delayed healing due to the wound infection.

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Pain at the radial side of the wrist may be caused by stenosing tenosynovitis of the flexor carpi radialis tendon. Typical in these cases is a tenderness over the tendon at the wrist. Pain is most often produced by pronation and especially by palmar flexion against resistance. The condition is caused by narrowing of the canal of flexor carpi radialis tendon within the wrist by nonspecific synovitis. In some cases osteoarthritis of the joint between the scaphoid and trapezium can compress the tendon and cause its attrition. If the pain is not relieved by conservative methods it can usually be cured by operative decompression of the canal.

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The pharmacokinetics of cyclosporin A (CS-A) were studied in 10 patients with primary biliary cirrhosis (PBC) after oral administration in steady state. Mean values for area under the blood concentration-time curve (AUC), time to maximal blood concentration (tmax), maximal blood concentration (Cmax) and elimination half-life (t1/2,z) were similar to results of previous studies in transplant patients. The variation between patients was large. No significant correlations of pharmacokinetic data with biochemical or histological parameters were found. Because of the high variability of pharmacokinetic parameters, patients with PBC treated with CS-A need to be regularly controlled for nephrotoxicity by estimation of serum creatinine and bioavailability (trough blood levels).

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