A therapeutic method for treating pressure ulcers like decubitus ulcers with biodegradable collagen flake compositions and with biodegradable collagen sponge or sponge-like compositions. The products of the inven tion includes biodegradable collagen flake compositions and biodegradable collagen sponge or sponge-like com positions. The products are useful for medical applica tions, like skin reconstruction, treatment of wounds, especially deep wounds, also in connection with sur gery, including cosmetic surgery. The invention also deals with biocompatible synthetic resin sponge or sponge-like and flake products for medical and similar applications. The invention contemplates the treatment of human and animal species.

Objectives. Prostate-specific antigen (PSA) exists in the serum in two clinically important molecular forms: free PSA and PSA complexed to alpha(1)-antichymotrypsin. Total PSA approximates the sum of the free and complexed forms. Preliminary investigations have illustrated the potential benefits of using percent free PSA to enhance the clinical utility of PSA in distinguishing benign prostate disease from prostate cancer. The current study defines the optimal range of total PSA for measuring percent free PSA (reflex range) and generates appropriate cutpoints for percent free PSA within this range.Methods. A total of 413 patients, 225 (54%) with benign prostate disease (mean age, 67 years) and 188 (46%) with prostate cancer (mean age, 66 years), who had PSA values between 2.0 and 20.0 ng/mL participated in the investigation. All patients underwent a sextant biopsy to establish the diagnosis. The serum specimens were assayed with the AxSYM PSA assay (total PSA) and AxSYM Free PSA assay (Abbott Laboratories; Abbott Park, IL). Percent free PSA was calculated for all patients. Receiver operating characteristic (ROC) curves were generated for various ranges of total PSA to determine the reflex range that maximized the increase in sensitivity and specificity of percent free PSA over total PSA. Within the optimal range, the ROC curves were utilized to generate cutpoints for percent free PSA to be used in clinical practice.Results. The appropriate reflex range for the utility of percent free PSA was 3.0 to 10.0 ng/mL. The appropriate cutpoint for percent free PSA when the total PSA value was 3.0 to 4.0 ng/mL to achieve 90% sensitivity for the detection of prostate cancer was 0.19. This approach resulted in a biopsy rate of 73% and a cancer detection rate of 44% in men with a total PSA value between 3.0 and 4.0 ng/mL. The appropriate cutpoint for percent free PSA when the total PSA value was 4.1 to 10.0 ng/mL to ensure 95% sensitivity for detection of prostate cancer was 0.24. Within the range of 4.1 to 10.0 ng/mL, this approach resulted in 13% fewer negative biopsies and failure to detect 5% of the cancers.Conclusions. Percent free PSA should be utilized in patients with a total serum PSA value between 3.0 and 10.0 ng/mL. In patients with a total PSA value between 3.0 and 4.0 ng/mL, percent free PSA enhanced the detection of prostate cancer (improving sensitivity). In patients with a total PSA concentration ranging from 4.1 to 10.0 ng/mL, negative biopsies were eliminated (improving specificity). Copyright 1997 by Elsevier Science Inc.

OBJECTIVES:This study analyzed methods of prostate cancer early detection in community settings throughout the United States against standards and findings of earlier studies conducted at academic medical centers. METHODS:The study was conducted at 148 clinical centers during Prostate Cancer Awareness Week in September 1993 and continued through June 1994. A total of 31,953 eligible subjects were tested by both digital rectal examination (DRE) and prostate-specific antigen (PSA). PSA was tested with the Abbott IMx PSA assay and reported by Roche Biomedical, Inc. RESULTS:The study confirmed that elevated PSA levels (greater than 4.0 ng/mL) aid in the detection of organ-confined prostate cancer when used in conjunction with the DRE. Reflecting more conservative biopsy decision-making practices, study results nonetheless are comparable to earlier reports. Among 1307 subjects who underwent biopsy, 322 cancers were detected. The cancer detection rate was 3.6% for PSA, 3.0% for DRE, and 4.7% if either test result was positive. The positive predictive value (PPV) for elevated PSA levels (greater than 4.0 ng/mL) was 3l.6%, significantly better (P < 0.0001) than the PPV for abnormal DRE results (25.5%). Nearly 90% (88.9%) of staged cancers were diagnosed as localized. Elevated PSA levels detected more localized cancers (76 of 105 [72.4%]) than the DRE (72 of 105 [68.6%]). Of localized tumors, 33 (31.4%) were missed by DRE and detected solely by PSA, and 29 (27.6%) were missed by PSA and detected solely by DRE. The combined use of the two methods detected 33 additional localized tumors. CONCLUSIONS:Community practice throughout the United States demonstrates that PSA and DRE are consistently effective and efficient in the early detection of prostate cancer.

Abstract: Granuloma formation and chronic inflammation are local reactions that are associated with implantation of medical grade silicone. These responses lead to capsular contraction, pain, and cosmetic problems. In addition, there have been a few reports of connective tissue disease in patients with silicone gel-filled implants. The purpose of this paper is to raise the possibility that local responses to silicone gel-filled implants are mediated by fat necrosis. Results of histologic findings and patient records in six patients indicate that patients experiencing implant leakage or failure exhibited classic signs of a foreign-body response, including the presence of giant cells and foamy macrophages. Most of the observed vacuoles were empty and appeared similar to enucleated fat cells, although some contained foreign material. These observations suggest that the physical presence or degradation products of the implants may have elicited fat cell necrosis that contributed to the chronic inflammatory response. In contrast, patients with intact implants showed no signs of a chronic foreign-body response. None of the patients in this study demonstrated any systemic complications. It is concluded that although there have been numerous reports of empty vacuoles containing silicone that are either derived from the membrane that surrounds the implant or from the gel, there are no reports linking these vacuoles to the vacuoles seen in fat tissue necrosis, even though histologically the two processes are morphologically similar. Therefore, it is important to ask whether some of the adverse reactions observed with silicone gel-filled implants may be mediated via fat cell necrosis.

The synthesis of type I and III collagens in cultured skin fibroblasts from normal skin, normal scar, hypertrophic scar, and keloids was examined. The ratio of type I/III collagen was significantly elevated in keloids compared to that in the other groups. When mRNA steady-state levels coding for alpha 1(I) procollagen were determined, it was apparent that this increase in the type I/III collagen ratio in keloids was paralleled by a specific increase in alpha 1(I) procollagen mRNA. This specific increase in alpha 1(I) procollagen mRNA in keloids was the result of increased gene expression because the transcription rate of the alpha 1(I) procollagen gene was significantly elevated in keloids, as determined by nuclear runoff transcription. The rate of transcription of the alpha 1(I) procollagen gene was also elevated in hypertrophic scars, although no concomitant increase in alpha 1(I) procollagen mRNA levels or alteration in the type I/III collagen ratio was observed. These data indicate that the rate of gene transcription of alpha 1(I) procollagen is increased in both hypertrophic scars and keloids, but only keloids exhibit increased steady-state levels of alpha 1(I) procollagen mRNA and concurrent increases in type I collagen. These results suggest that at least two distinct mechanisms, one pretranscriptional and one post-transcriptional, regulate type I collagen synthesis. It is possible, therefore, that in keloids, neither mechanism functions efficiently to down-regulate type I collagen. In hypertrophic scars, however, the post-transcriptional mechanisms are able to decrease elevated levels of mRNA coding for alpha 1(I) procollagen that result from increased transcription of the alpha 1(I) procollagen gene.

Rapid fibroblast ingrowth and collagen deposition occurs in a reconstituted type I collagen matrix that is implanted on full-thickness excised animal dermal wounds. The purpose of this study is to evaluate the effects of direct current stimulation on dermal fibroblast ingrowth using carbon fiber electrodes incorporated into a collagen sponge matrix. Preliminary results suggest that fibroblast ingrowth and collagen fiber alignment are increased in collagen sponges stimulated with direct currents between 20 and 100 microA. Maximum fibroblast ingrowth into the collagen sponge is observed near the cathode at a current of 100 microA. These results suggest that electrical stimulation combined with a collagen matrix may be a method to enhance the healing of chronic dermal wounds.

Type I collagen in a porous sponge form attracts fibroblasts in culture and accelerates repair of animal wounds. This study examines the effect of type I collagen sponge and flakes on healing of chronic skin ulcers. Patients included in this study had skin ulcers. Patients included in this study had skin ulcers characterized by loss of dermis and epidermis without exposure of muscle, tendon or bone. Patients showing evidence of systemic infection or patients with ulcers that decreased in area during an initial three week observation period were excluded. Three out of seven patients treated with a collagen sponge and twelve out of fourteen patients treated with collagen flakes showed a 40% decrease in wound area after six weeks of treatment. In comparison, eighteen control patients showed no change in wound area over the same time interval. These results suggest that collagen flakes are effective in initiating healing of chronic skin ulcers.

A noninvasive ultrasonic technique has been designed to measure the hemodynamic variables associated with human right ventricular diastole. For convenience, diastole is divided into five phases: rapid filling, slow filling, early resting, atrial systole, and late resting phases. The technique measures the velocity with which blood enters the ventricule during each phase, and relates these measurements to ventricular wall motion. The technique has been evaluated by comparing the measurements with data derived from an alternative technique: forward angiocardiography taken during cardiac catheterization. In this procedure, blood containing dye can be followed through the ventricle by X-ray, and velocity measurements can be made from the cinefluoroscopic films. Cinefluoroscopy has also defined potential problems related to turbulence and heart motion. Ultrasonic and cardiac catheterization measurements agreed well. The ultrasonic equipment can be carried by hand from one room to another is inexpensive, and is readily available. This equipment can be used on the same subject repeatedly without discomfort or danger, and can be used during exercise.

Extensive soft-tissue avulsion injuries of the upper extremities with or without bony involvement are difficult reconstructive problems. They usually cannot be adequately managed by traditional methods using skin grafts or local flaps. Microvascular free-tissue transplantation may offer the best chance for success with these severe injuries. Free-tissue transfer is indicated in this type of injury (1) when no simpler method of obtaining a closed wound is available, or (2) when the quality of soft-tissue coverage by simpler methods would not be adequate from a functional standpoint. For example, if a skin graft is placed over bone and tendons, there may be impairment of function, and certainly this is a poor environment for tendon transfers, nerve repairs, and so forth. The much more adequate tissue of a free-flap coverage provides a better environment for reconstruction. Three cases demonstrating these principles have been presented.

One hundred patients with invasive melanoma of the head and neck were treated by one surgeon from 1970 to 1978. Lymph node dissections were performed in 77 patients for palpable adenopathy, local recurrence, or tumor thickness greater than 0.75 mm when measured by micrometry. No patient whose lesion was less than 1.0 mm thick had a local recurrence or died as a result of melanoma. Patients who underwent elective lymph node dissection with findings of up to two positive nodes had a 53 to 56 percent 5 year survival rate, while those with three or more nodes had a poor prognosis (15 percent 5 year survival rate). The patterns of recurrence showed that relapse after nodal dissection usually presented with systemic metastases. The data support a therapeutic scheme based on 2 to 5 cm wide excision alone for lesions less than 0.75 mm in thickness and elective nodal dissection for specific indications.

Aplasia cutis congenita is an uncommon condition; fewer than 300 cases have been reported in the literature. Usually, the condition occurs as a focal scalp ulcer, but it may involve the full thickness of the skull or other areas of the body. Most lesions require coverage with a scalp flap, though only observation or split-thickness skin grafts may be adequate for smaller lesions. Four cases have been presented, representing a spectrum of therapeutic requirements from simple observation to emergency intervention to control life-threatening hemorrhage. The case of aplasia cutis congenita of the upper arm may represent a persistence of prenatal focal ischemia that has proved to be resistant to numerous attempts of split-thickness skin grafting.