Adherence to subcutaneous interferon beta-1a treatment using an electronic injection device: a prospective open-label Scandinavian noninterventional study (the ScanSmart study).

BACKGROUND: Disease modifying drugs help control the course of relapsing remitting multiple sclerosis (RRMS); however, good adherence is needed for long-term outcomes. OBJECTIVE: To evaluate patient adherence to treatment with subcutaneous interferon beta-1a using RebiSmart® and assess injection-site reactions and treatment satisfaction. METHODS: This prospective, single-arm, open-label, noninterventional multicenter Phase IV trial included disease modifying drug-experienced mobile patients with RRMS. Adherence was measured over 12 weeks. Items 13-23, 35, 37, and 38 of the Multiple Sclerosis Treatment Concerns Questionnaire (injection-site reactions and treatment satisfaction) were recorded at 12 weeks. RESULTS: Sixty patients were recruited (mean age 43.7 [±SD 7.9] years; 83% female; mean years since multiple sclerosis diagnosis 6.7 [SD 4.5]). Adherence data were obtained in 54 patients only due to technical problems with six devices. Over 12 weeks, 89% (n=48) of patients had ≥90% adherence to treatment. Most patients experienced mild influenza-like symptoms and injection-site reactions, and global side effects were minimal. Most patients (78%) rated the convenience as the most important aspect of the device, and most experienced no or mild pain. CONCLUSION: RRMS patients treated with subcutaneous interferon beta-1a, administered with RebiSmart, demonstrated generally good adherence, and the treatment was generally well tolerated.

The effect of a corticosteroid cream and a barrier-strengthening moisturizer in hand eczema. A double-blind, randomized, prospective, parallel group clinical trial.

BACKGROUND: Hand eczema is a common and persistent disease with a relapsing course. Clinical data suggest that once daily treatment with corticosteroids is just as effective as twice daily treatment. OBJECTIVES: The aim of this study was to compare once and twice daily applications of a strong corticosteroid cream in addition to maintenance therapy with a moisturizer in patients with a recent relapse of hand eczema. METHODS: The study was a parallel, double-blind, randomized, clinical trial on 44 patients. Twice daily application of a strong corticosteroid cream (betamethasone valerate 0.1%) was compared with once daily application, where a urea-containing moisturizer was substituted for the corticosteroid cream in the morning. The investigator scored the presence of eczema and the patients judged the health-related quality of life (HRQoL) using the Dermatology Life Quality Index (DLQI), which measures how much the patient's skin problem has affected his/her life over the past week. The patients also judged the severity of their eczema daily on a visual analogue scale. RESULTS: Both groups improved in terms of eczema and DLQI. However, the clinical scoring demonstrated that once daily application of corticosteroid was superior to twice daily application in diminishing eczema, especially in the group of patients with lower eczema scores at inclusion. CONCLUSIONS: Twice daily use of corticosteroids was not superior to once daily use in treating eczema. On the contrary, the clinical assessment showed a larger benefit from once daily treatment compared with twice daily, especially in the group of patients with a moderate eczema at inclusion.

Functional free latissimus dorsi muscle flap to the proximal lower extremity.

Surgical treatment of lower extremity sarcoma often requires complete resection of muscle compartments resulting in disabling functional loss. Free muscle transfer has been used to restore function of the face and upper extremities, but few reports exist describing functional restoration of a lower extremity. A case report of a 21-year-old man requiring complete resection of the quadriceps musculature with successful functional reconstruction using a free latissimus dorsi muscle flap is described.

Topical 5-fluorouracil as primary therapy for keratoacanthoma.

Keratoacanthoma is a common, benign cutaneous neoplasm that displays rapid growth on sun-exposed skin. Keratoacanthomas usually involute spontaneously after several months but rarely progress to squamous cell carcinoma. Because this is a benign, self-limited lesion of exposed skin, effective treatment should emphasize patient comfort and cosmetic results in addition to effectiveness. The authors present 2 patients with keratoacanthomas treated with topical 5-fluorouracil. Both patients had complete resolution of their lesions within 8 weeks. The cosmetic result was superb in both patients. Patient satisfaction with this therapy was excellent. Treatment can be instituted based on a clinical diagnosis; no diagnostic biopsy is necessary. Most keratoacanthomas respond to topical 5-fluorouracil therapy within 3 weeks, whereas squamous cell carcinomas respond poorly. Any lesion that shows a poor response after 3 weeks of therapy or that does not resolve within 8 weeks should undergo prompt excisional biopsy for definitive diagnosis and treatment. Topical 5-fluorouracil is an effective, convenient, relatively inexpensive treatment for keratoacanthoma that produces excellent cosmetic results. It should be added to the therapeutic armamentarium of all physicians who treat keratoacanthoma.

Collagenous fibroma (desmoplastic fibroblastoma).

Collagenous fibroma (desmoplastic fibroblastoma) is a recently described tumor that may arise in the subcutaneous tissue or skeletal muscle. We report a case of collagenous fibroma, occurring on the forehead of a 67-year-old man. An awareness of this entity is necessary to avoid confusion with other soft tissue neoplasms, especially extraabdominal fibromatosis.

NC100100, a new echo contrast agent for the assessment of myocardial perfusion--safety and comparison with technetium-99m sestamibi single-photon emission computed tomography in a randomized multicenter study.

BACKGROUND AND HYPOTHESIS: Myocardial contrast echocardiography using second-generation agents has been proposed to study myocardial perfusion. A placebo-controlled, multicenter trial was conducted to evaluate the safety, optimal dose, and imaging mode for NC100100, a novel intravenous second-generation echo contrast agent, and to compare this technique with technetium-99m sestamibi (MIBI) single-photon emission computed tomography (SPECT). METHODS: In a placebo-controlled, multicenter trial, 203 patients with myocardial infarction > 5 days and < 1 year previously underwent rest SPECT and MCE. Fundamental and harmonic imaging modes combined with continuous and electrocardiogram-- (ECG) triggered intermittent imaging were used. Six dose groups (0.030, 0.100, and 0.300 microliter particles/kg body weight for fundamental imaging; and 0.006, 0.030, and 0.150 microliter particles/kg body weight for harmonic imaging) were tested. A saline group was also included. Safety was followed for 72 h after contrast injection. Myocardial perfusion by MCE was compared with myocardial rest perfusion imaging using MIBI as a tracer. RESULTS: NC100100 was well tolerated. No serious adverse events or deaths occurred. No clinically relevant changes in vital signs, laboratory parameters, and ECG recordings were noted. There was no significant difference between adverse events in the NC100100 (25.7%) and in the placebo group (17.9%, p = 0.3). Intermittent harmonic imaging using the intermediate dose was superior to all other modalities, allowing the assessment of perfusion in 76% of all segments. Eighty segments (96%) with normal perfusion by SPECT imaging also showed myocardial perfusion with MCE. However, a substantial percentage of segments (61-80%) with perfusion defects by SPECT imaging also showed opacification by MCE. This resulted in an overall agreement of 66-81% and a high specificity (80-96%), but in low sensitivity (20-39%) of MCE for the detection of perfusion defects. CONCLUSION: NC100100 is safe in patients with myocardial infarction. Intermittent harmonic imaging with a dose of 0.03 microliter particles/kg body weight can be proposed as the best imaging protocol. Myocardial contrast echocardiography with NC 100100 provides perfusion information in approximately 76% of segments and results in myocardial opacification in the vast majority of segments with normal perfusion as assessed by SPECT. Although the discrepancies between MCE and SPECT with regard to the definition of perfusion defects requires further investigation, MCE with NC 100100 is a promising technique for the noninvasive assessment of myocardial perfusion.

Upper extremity salvage using the tensor fascia lata flap: report of two cases.

The tensor fascia lata pedicled flap was successfully used to salvage 3 severely injured upper extremities in 2 patients. Both patients had undergone 3 prior free tissue transfers without complete closure of their wounds. All 3 tensor fascia lata flaps (2 myocutaneous, 1 myofascial) survived entirely. We believe this flap offers a distinct advantage compared with the groin flap when pedicled flap coverage of the upper extremity is required.

Accuracy and feasibility of contrast echocardiography for detection of perfusion defects in routine practice: comparison with wall motion and technetium-99m sestamibi single-photon emission computed tomography. The Nycomed NC100100 Investigators.

OBJECTIVES: We sought to assess the feasibility and accuracy of myocardial contrast echocardiography (MCE) using standard imaging approaches for the detection of perfusion defects in patients who had a myocardial infarction (MI). BACKGROUND: Myocardial contrast echocardiography may be more versatile than perfusion scintigraphy for identifying the presence and extent of perfusion defects after MI. However, its reliability in routine practice is unclear. METHODS: Fundamental or harmonic MCE was performed with continuous or triggered imaging in 203 patients with a previous MI using bolus doses of a perfluorocarbon-filled contrast agent (NC100100). All patients underwent single-photon emission computed tomography (SPECT) after the injection of technetium-99m (Tc-99m) sestamibi at rest. Quantitative and semiquantitative SPECT, wall motion and digitized echocardiographic data were interpreted independently. The accuracy of MCE was assessed for detection of segments and patients with moderate and severe sestamibi-SPECT defects, as well as for detection of patients with extensive perfusion defects (>12% of left ventricle). RESULTS: In segments with diagnostic MCE, the segmental sensitivity ranged from 14% to 65%, and the specificity varied from 78% to 95%, depending on the dose of contrast agent. Using both segment- and patient-based analysis, the greatest accuracy and proportion of interpretable images were obtained using harmonic imaging in the triggered mode. For the detection of extensive defects, the sensitivity varied from 13% to 48%, with specificity from 63% to 100%. Harmonic imaging remained the most accurate approach. Time since MI and SPECT defect location and intensity were all determinants of the MCE response. The extent of defects on MCE was less than the extent of either abnormal wall motion or SPECT abnormalities. The combination of wall motion and MCE assessment gave the best balance of sensitivity (46% to 55%) and specificity (82% to 83%). CONCLUSIONS: Although MCE is specific, it has limited sensitivity for detection of moderate or severe perfusion defects, and it underestimates the extent of SPECT defects. The best results are obtained by integration with wall motion. More sophisticated methods of acquisition and interpretation are needed to enhance the feasibility of this technique in routine practice.

Lag-screw technique in free osseous mandibular reconstruction.

The surgical registry was reviewed for mandibular reconstruction from 1988 to 1992. During this time, 51 patients underwent mandibular reconstruction. Of this group, 17 patients had their microvascular bone grafts secured with lag-screw fixation. An AO technique, utilizing 2.7-mm cortical screws, was used to provide rigid fixation. Mandibular defects ranged from 6 to 20 cm. AO vascularized bone grafts were studied with bone scans and remained viable. Follow-up revealed no flap losses or oral cutaneous fistulae. Lag-screw fixation, in conjunction with mandibular reconstruction, results in rigid fixation, obviates the need for mandibulamaxillary fixation, has the advantage of ease of application, and is safe to use.

An algorithm for maxillectomy defect reconstruction.

A maxillectomy defect creates a communication from oral cavity to nasal cavity that may extend to the orbit. Functional deglutition and speech problems with a significant soft tissue deficit ensue. This paper defines the reconstruction options for the spectrum of inferior partial maxillectomy defects to midface-orbital exonerations. Treatment protocols from maxillectomy patients treated in January 1991 to February 1996 at a major tertiary care institution were reviewed (n = 108). An ascension of care from dental obturator, nonvascularized graft, local flap, regional flap, and free tissue grafts (n = 28) is described. These data and experience were organized to provide a treatment algorithm to assist in presurgical planning for maxillectomy reconstruction.

Angiosarcomas of the head and neck: clinical and pathologic characteristics.

Between 1974 and 1992, 32 patients with pathologically diagnosed angiosarcoma of the head and neck were evaluated at our institution. The primary treatment group consisted of 24 patients who had the initial diagnosis made or confirmed at our institution, and the other 8 patients formed the salvage group. There were 23 men and 9 women. The median age in the primary treatment group was 63 years (range 18 to 91 years). The overall median survival among the primary group patients was 4.8 years, and the 3-year survival was estimated to be 57% (95% confidence interval 39% to 84%). The median follow-up was 2.1 years (range 83 days to 9.7 years). Patients who had tumors less than 7.0 cm in diameter and tumors with invasion only to the subcutaneous tissues had better overall survival and longer time to first adverse event. Diploid DNA content was a significant favorable prognostic factor for time to first adverse event. Mitotic activity was of borderline significance with both end points. Patients who had tumors of less than 1.5 cm were treated successfully with surgery alone. Patients treated with combined surgery and radiotherapy also tended to do better. Because most patients in whom regional recurrences developed had tumors larger than 7.0 cm, we conclude that patients with tumors of this size may benefit from regional neck node dissection at the time of primary excision or from elective neck irradiation.

Tissue expansion in the upper extremities.

In this article, the authors demonstrate current concepts of soft-tissue reconstruction using tissue expansion principles. History, pathophysiology, and biomechanics of tissue expansion are reviewed. Anatomic areas of expander use in the upper extremity have been delineated, as well as new concepts of nerve and arterial elongation using intraoperative expansion techniques. The authors outline their current technique of upper extremity tissue expansion in the preoperative, intraoperative, and postoperative settings, allowing the reader to appreciate the technique of tissue expansion and its role in soft-tissue reconstruction of the upper extremity.

Muscle flap reconstruction aids in urethral regeneration.

Traditional methods of reconstructing full-thickness urethral defects have employed a cutaneous component utilized to replace the lining of the urethra. These methods have failed to take advantage of the regenerative ability of urethral epithelium. This epithelium is capable of regenerating, eliminating the need for urethral lining reconstruction. Muscle flap reconstruction provides an environment that allows for complete regeneration of the urethral epithelium. A 56-year-old male presented with a 12-cm defect of the bulbous and penile urethra involving 180 degrees of the urethral circumference secondary to Fournier's gangrene. A proximally pedicled gracilis muscle was used to reconstruct the urethral defect. This healed without stricture or leak. Urethral biopsies showed satisfactory migration of the uroepithelium across the urethral defect.

Functional lower limb salvage with an osteocutaneous filet flap of the foot.

An osteocutaneous foot filet flap based on the posterior tibial vessels was successfully used to provide tibial coverage in a patient requiring a below-knee amputation following a high-voltage electrical injury. Addition of the calcaneus to the standard foot filet flap provided a vascularized bone graft that served to both lengthen the tibia and secure the flap via a tibial-calcaneal synostosis. The synostosis provided firm anchoring of the flap and allowed for a partial end-bearing, below-knee prosthesis.

Management of sacral and perineal defects following abdominoperineal resection and radiation with transpelvic muscle flaps.

PURPOSES: In this study we present our experience with treating persistent sacral and perineal defects secondary to radiation and abdominoperineal resection with or without sacrectomy. METHODS: Fifteen consecutive patients were treated with an inferiorly based transpelvic rectus abdominis muscle or musculocutaneous flap. RESULTS: Fourteen of the 15 patients achieved healing, and 7 patients had no complications. The remaining eight patients required one or more operative debridements and/or prolonged wound care to accomplish a healed wound. Our technique for the dissection and insetting of the transpelvic muscle flap is presented. CONCLUSION: The difficult postirradiated perineal and sacral wounds can be healed with persistent surgical attention to adequate debridement, control of infections, and a well-vascularized muscle flap. The most satisfying aspects for patients are the discontinuance of foul-smelling discharge, discontinuation of multiple, daily dressing changes, and reduction in the degree of chronic pain.

Autologous breast reconstruction with use of transverse rectus abdominis musculocutaneous flap: Mayo clinic experience with 147 cases.

OBJECTIVE: To assess the results of transverse rectus abdominis musculocutaneous (TRAM) flap reconstructions of the breast. DESIGN: We retrospectively reviewed 147 consecutive cases of TRAM reconstructions of the breast performed at the Mayo Clinic between 1981 and 1992. MATERIAL AND METHODS: The median patient age was 47 years, and the median duration of follow-up was 29 months. In 25 patients, both rectus pedicles were used, 15 of those for bilateral reconstruction. The other 122 patients had unipedicled unilateral reconstruction. Only 9% of the breast reconstructions were immediate. Analysis of risk factors in the patient population revealed smoking in 16%, preoperative irradiation of the chest wall in 20%, preoperative chemotherapy in 27%, and both radiotherapy and chemotherapy in 12%. RESULTS: The mean overall operative time was 4 hours and 43 minutes (4 hours and 20 minutes for unipedicled flaps and 5 hours and 46 minutes for bipedicled reconstructions). No blood transfusion was needed in 47% of patients; of those who received transfusions, 78% required 2 units or less. In 58 of the 147 patients (39%), an operation was performed on the contralateral breast. Follow-up operations were necessary in 71% of patients. The overall frequency of complications was as follows: hernia that necessitated surgical repair, 7.5%; full TRAM ischemic loss, 3.7%; partial TRAM loss, 9.9%; and fat necrosis, 11.7%. No pattern of increased complications was noted in subgroups of patients who smoked or who had received preoperative irradiation, chemotherapy, or both. In comparison with our early cases, the last 50 TRAM procedures were generally associated with fewer complications. The rates of occurrence of complications in our series of patients were similar to those reported in the literature. CONCLUSION: The TRAM flap provides satisfactory results for reconstruction of the breast.