Reliability of Repeated Measurements on Post-Burn Scars with Corneometer CM 825(®).

BACKGROUND/PURPOSE: The water content in burn scars, the parameter of stratum corneum water holding capacity, is an important feature in evaluation of biophysical properties of scars. Nevertheless, quantifiying this parameter is a challenge. In this study, the reliability of repeated water content measurements with Corneometer CM825(®) on (burn) scars was investigated. METHODS: Intra-observer reliability, inter-observer reliability and day-by-day variability were examined on 30 scars by means of intra-class correlation coefficient (ICC) and within-subject coefficient of variation (WSCV). Bland-Altman plots with '95% limits of agreement' were constructed. RESULTS: Results revealed excellent ICC values (ICCintra  = 0.985; ICCinter  = 0.984) with relatively low WSCV (WSCVintra  = 6.3%; WSCVinter  = 10.6%) for respectively intra- and inter-observer reliability. However, the Bland-Altman plot showed that more than 5% of differences were expected to exceed 4 a.u., the limit of what has been defined as a clinically acceptable difference. Results for day-by-day variability showed good ICC value (ICCday-by-day  = 0.849) and higher WSCV (WSCVday-by-day  = 20.5%). CONCLUSION: The Corneometer CM825(®) is an objective and sensitive instrument for water content measurements. On the basis of our results, we concluded that the instrument can be used in clinical trials, but only under very strict conditions with standardized test protocol, preferably in combination with the evaluation of other physiological parameters.

Diagnosis and treatment of primary lymphedema. Consensus document of the International Union of Phlebology (IUP)-2013.

Primary lymphedema can be managed effectively as a form of chronic lymphedema by a sequenced and targeted treatment and management program based around a combination of Decongestive Lymphatic Therapy (DLT) with compression therapy, when the latter is desired as an adjunct to DLT. Treatment in the maintenance phase should include compression garments, self-management, including self-massage, meticulous personal hygiene and skin care, in addition to lymphtransport-promoting excercises and activities, and, if desired, pneumatic compression therapy applied in the home. When conservative treatment fails, or gives sub-optimal outcomes, the management of primary lymphedema can be improved, where appropriate, with the proper addition of surgical interventions, either reconstructive or ablative. These two surgical therapies can be more effective when fully integrated with manual lymphatic drainage (MLD)-based DLT postoperatively. Compliance with a long-term commitment to MLD/DLT and particularly compression postoperatively is a critical factor in determining the success of any new treatment strategy involving either reconstructive or palliative surgery. The future of management of primary lymphedema has never been brighter with the new prospect of gene-and perhaps stem-cell oriented management.

Comparison of foot segmental mobility and coupling during gait between patients with diabetes mellitus with and without neuropathy and adults without diabetes.

BACKGROUND: Reduction in foot mobility has been identified as a key factor of altered foot biomechanics in individuals with diabetes mellitus. This study aimed at comparing in vivo segmental foot kinematics and coupling in patients with diabetes with and without neuropathy to control adults. METHODS: Foot mobility of 13 diabetic patients with neuropathy, 13 diabetic patients without neuropathy and 13 non-diabetic persons was measured using an integrated measurement set-up including a plantar pressure platform and 3D motion analysis system. In this age-, sex- and walking speed matched comparative study; differences in range of motion quantified with the Rizzoli multisegment foot model throughout different phases of the gait cycle were analysed using one-way repeated measures analysis of variance (ANOVA). Coupling was assessed with cross-correlation techniques. FINDINGS: Both cohorts with diabetes showed significantly lower motion values as compared to the control group. Transverse and sagittal plane motion was predominantly affected with often lower range of motion values found in the group with neuropathy compared to the diabetes group without neuropathy. Most significant changes were observed during propulsion (both diabetic groups) and swing phase (predominantly diabetic neuropathic group). A trend of lower cross-correlations between segments was observed in the cohorts with diabetes. INTERPRETATION: Our findings suggest an alteration in segmental kinematics and coupling during walking in diabetic patients with and without neuropathy. Future studies should integrate other biomechanical measurements as it is believed to provide additional insight into neural and mechanical deficits associated to the foot in diabetes.

Chronic edema of the lower extremities: international consensus recommendations for compression therapy clinical research trials.

Chronic edema is a multifactorial condition affecting patients with various diseases. Although the pathophysiology of edema varies, compression therapy is a basic tenant of treatment, vital to reducing swelling. Clinical trials are disparate or lacking regarding specific protocols and application recommendations for compression materials and methodology to enable optimal efficacy. Compression therapy is a basic treatment modality for chronic leg edema; however, the evidence base for the optimal application, duration and intensity of compression therapy is lacking. The aim of this document was to present the proceedings of a day-long international expert consensus group meeting that examined the current state of the science for the use of compression therapy in chronic edema. An expert consensus group met in Brighton, UK, in March 2010 to examine the current state of the science for compression therapy in chronic edema of the lower extremities. Panel discussions and open space discussions examined the current literature, clinical practice patterns, common materials and emerging technologies for the management of chronic edema. This document outlines a proposed clinical research agenda focusing on compression therapy in chronic edema. Future trials comparing different compression devices, materials, pressures and parameters for application are needed to enhance the evidence base for optimal chronic oedema management. Important outcomes measures and methods of pressure and oedema quantification are outlined. Future trials are encouraged to optimize compression therapy in chronic edema of the lower extremities.

A new device to measure upper limb circumferences: validity and reliability.

AIM: The aim of this paper was to examine the reliability and validity of a new measurement device that counters the disadvantages of the traditional method of arm circumference measurements. METHODS: We measured the arm on the non-operated side of breast cancer patients. Sixty-four patients were measured twice by the same assessor and 48 patients were measured twice by two different assessors. The arm circumferences were measured at the olecranon and each 4 cm proximal and distal of the olecranon. The measurements were performed with a self-developed device consisting of a stainless steel bar on which a tapeline was fixed at every 4 cm distance. The arm volume was calculated from the circumference measurements with the frustrum formula and was also measured directly with the water displacement method. RESULTS: For the circumference measurements, intrarater and interrater ICCs ranged between 0.942 and 0.998. ICCs for the calculated arm volume were also very high. No systematic changes between the first to the second assessment could be found. The standard error of measurement for the circumference measurements as well as for the calculated arm volume was low (between 0.8% and 2.0%). An increase of 1.0 cm or more of the arm circumference at any measurement side and of 55 ml or more of the calculated arm volume was clinically significant. CONCLUSION: Arm circumferences and also the calculated arm volume can be measured quickly and accurately with a simple and inexpensive device.

Clinical trials needed to evaluate compression therapy in breast cancer related lymphedema (BCRL). Proposals from an expert group.

AIM: A mainstay of lymphedema management involves the use of compression therapy. Compression therapy application is variable at different levels of disease severity. Evidence is scant to direct clinicians in best practice regarding compression therapy use. Further, compression clinical trials are fragmented and poorly extrapolable to the greater population. An ideal construct for conducting clinical trials in regards to compression therapy will promote parallel global initiatives based on a standard research agenda. The purpose of this article is to review current evidence in practice regarding compression therapy for BCRL management and based on this evidence, offer an expert consensus recommendation for a research agenda and prescriptive trials. Recommendations herein focus solely on compression interventions. METHODS: This document represents the proceedings of a session organized by the International Compression Club (ICC) in June 2009 in Ponzano (Veneto, Italy). The purpose of the meeting was to enable a group of experts to discuss the existing evidence for compression treatment in breast cancer related lymphedema (BCRL) concentrating on areas where randomized controlled trials (RCTs) are lacking. RESULTS: The current body of research suggests efficacy of compression interventions in the treatment and management of lymphedema. However, studies to date have failed to adequately address various forms of compression therapy and their optimal application in BCRL. We offer recommendations for standardized compression research trials for prophylaxis of arm lymphedema and for the management of chronic BCRL. Suggestions are also made regarding; inclusion and exclusion criteria, measurement methodology and additional variables of interest for researchers to capture. CONCLUSION: This document should inform future research trials in compression therapy and serve as a guide to clinical researchers, industry researchers and lymphologists regarding the strengths, weaknesses and shortcomings of the current literature. By providing this construct for research trials, the authors aim to support evidence-based therapy interventions, promote a cohesive, standardized and informative body of literature to enhance clinical outcomes, improve the quality of future research trials, inform industry innovation and guide policy related to BCRL.

Diagnosis and treatment of primary lymphedema. Consensus document of the International Union of Phlebology (IUP)-2009.

Primary lymphedema can be managed safely as one of the chronic lymphedemas by a proper combination of DLT with compression therapy. Treatment in the maintenance phase should include compression garments, self management including the compression therapy, self massage and meticulous personal hygiene and skin care in addition to lymph-transport promoting excercises. The management of primary lymphedema can be further improved with proper addition of surgical therapy either reconstructive or ablative. These two surgical therapies can be effective only when fully integrated with MLD-based DLT postoperatively. Compliance with a long-term commitment of DLT postoperatively is the most critical factor determining the success of any new treatment strategy with either reconstructive or palliative surgery. The future of management of primary lymphedema caused by truncular lymphatic malformation has never been brighter with the new prospect of gene-oriented management.

Indications for compression therapy in venous and lymphatic disease consensus based on experimental data and scientific evidence. Under the auspices of the IUP.

AIM: The aim of this study was to review published literature concerning the use of compression treatments in the management of venous and lymphatic diseases and establish where reliable evidence exists to justify the use of medical compression and where further research is required to address areas of uncertainty. METHODS: The authors searched medical literature databases and reviewed their own collections of papers, monographs and books for papers providing information about the effects of compression and randomized clinical trials of compression devices. Papers were classified in accordance with the recommendations of the GRADE group to categorize their scientific reliability. Further classification was made according to the particular clinical problem that was addressed in the papers. The review included papers on compression stockings, bandages and intermittent pneumatic compression devices. RESULTS: The International Compression Club met once in Vienna and corresponded by email in order to reach an agreement of how the data should be interpreted. A wide range of compression levels was reported to be effective. Low levels of compression 10-30 mmHg applied by stockings are effective in the management of telangiectases after sclerotherapy, varicose veins in pregnancy, the prevention of edema and deep vein thrombosis (DVT). High levels of compression produced by bandaging and strong compression stockings (30-40 mmHg) are effective at healing leg ulcers and preventing progression of post-thrombotic syndrome as well as in the management of lymphedema. In some areas no reliable evidence was available to permit recommendations of level of compression or duration of treatment. These included: management of varicose veins to prevent progression, following surgical treatment or sclerotherapy for varicose veins, and the level of compression required to treat acute DVT. CONCLUSION: This review shows that whilst good evidence for the use of compression is available in some clinical indications, there is much still to be discovered. Little is know about dosimetry in compression, for how long and at what level compression should be applied. The differing effects of elastic and short-stretch compression are also little understood.

Guidelines for clinical studies with compression devices in patients with venous disorders of the lower limb.

OBJECTIVES: The scientific quality of published clinical trials is generally poor in studies where compression devices have been assessed in the management of venous disease. The authors' aim was to establish a set of guidelines which could be used in the design of future clinical trials of compression treatments for venous diseases. DESIGN: Consensus conference leading to a consensus statement. METHODS: The authors form a expert consensus group known as the International Compression Club (ICC). This group obtained published medical literature in the field of compression treatment in venous disease by searching medical literature databases. The literature was studied by the group which attended a consensus meeting. A draft document was circulated to ICC members and revised until agreement between contributors was reached. RESULTS: The authors have prepared a set of guidelines which should be given consideration when conducting studies to assess the efficacy of compression in venous disease. CONCLUSIONS: The form of compression therapy including the comparators used in the clinical study must be clearly characterised. In future studies the characteristics of the material provided by the manufacturer should be described including in vivo data on pressure and stiffness of the final compression system. The pressure exerted on the distal lower leg should be stated in mmHg and the method of pressure determination must be quoted.

Chronic radiodermatitis following percutaneous coronary interventions: a report of two cases.

We describe two patients in whom chronic radiodermatitis with therapy-resistant ulceration of the right scapular region developed, following percutaneous coronary intervention with fluoroscopic imaging. Contrary to most reported cases in the literature, which involve numerous cardiac catheterization procedures, in both patients described here the total radiation dose was given during two successive procedures, involving difficult and prolonged coronary intervention with stent implantation. In both cases, local treatment of the ulcerative lesions was insufficient, necessitating excision of the radiodermatitis area and replacement with a skin graft, with good therapeutic result. The incidence of radiodermatitis after percutaneous coronary interventions is rising with the increasing number and complexity of these procedures. The main risk factor is a long duration of fluoroscopy using the same incidence. The skin lesions encompass a wide spectrum, ranging from erythema, telangiectasia, atrophy, hyperpigmentation and hypopigmentation to necrosis, chronic ulceration and squamous cell carcinoma. The lesions can appear from 15 days to 10 years after the procedure. To prevent radiation-induced injury, the radiation dose has to be limited and monitored. Also, careful inspection of the skin at the site of exposure is necessary and the radiographic beam has to be restricted to the smallest field size. A good clinical follow-up at regular intervals is important after long and complicated procedures.

Reproducibility of repeated measurements on healthy skin with Minolta Chromameter CR-300.

BACKGROUND/AIMS: In this report the reproducibility of measurements with the Minolta Chromameter CR-300 on healthy skin was investigated. METHODS: Intra- and inter-rater reproducibility, reproducibility with two instruments and repeated measurements with a 1 week time lapse were examined on healthy skin of 30 volunteers by means of intra-class correlation coefficients (ICC) and standard error of measurements (SEM). RESULTS: Results showed excellent values for ICC in all the four conditions. CONCLUSIONS: On the basis of these results we concluded that the instrument provides reliable information and can be used in comparative clinical trials.

Pharmacological treatment of wounds.

Systemic treatment of patients with wounds can be directed at several physiological aspects of healing during the consecutive phases of tissue repair. Many approaches to pharmacological treatment have been tested in vitro, in animal experiments, or in clinical studies. Investigators and clinicians focus on treating underlying metabolic, infectious, inflammatory, or hemorrheological diseases and their complications. Drug treatment is often adjuvant or complementary to other measures such as compression, surgical intervention, reconstruction, or reopening procedures. This compounding fact can render interpretation of the results more difficult. As systemic treatment is not always without side-effects; local wound management is an option to consider. Topically applied growth factors certainly have the potential to influence the healing process. An indirect way of providing growth factors to wounds and chronic ulcers can be achieved by the application of grafts, cultured keratinocytes, and skin substitutes. Modulation of angiogenesis during wound healing is a recent target for research and treatment. Future reviews probably also will include genetic engineering methods for influencing wound healing.

Inter-observer variation in the assessment of skin ulceration.

Six observers (three physicians and three nurses) assessed 27 wounds of different types in 20 elderly patients, using five different classification systems. Using classification by colours, inter-observer agreement was moderate when six colours were used (70% agreement, group kappa 53%), and good if this was reduced to three (80% agreement, group kappa 64%). Results were only moderate using the Shea scoring system (68% agreement, group kappa 42%). Assessment for signs of infection was fair to moderate (75-85% agreement, group kappa 29-55%), but there was high inter-observer agreement for size and area (analysis of variance, p > or = 0.88).

Differential temperature sensitivity of cultured cells from cartilaginous or bone origin.

The effects of long-term exposure to hyperthermia were studied on several cell cultures of cartilaginous or bone origin after a 4-day treatment at 40 degrees C. Chondrocytes proliferation, as well as mitochondrial activity were not modified by these culture conditions (40 degrees C) but protein content and cell volume were increased. In contrast, the proliferative capacity of osteoblasts, MC3T3.E1 a and ROS 17/2.8 was decreased and their protein content, cell volume and mitochondrial activity were increased. Chondrocytes appeared to be thermoresistant, and osteoblastic cells thermosensitive. Furthermore, temperature sensitivity was greater for the continuous established osteoblastic cell line MC3T3.E1 and for the cancerous established osteoblastic cell line ROS 17/2.8 than for chondrocytes.