Visually induced nausea causes characteristic changes in cerebral, autonomic and endocrine function in humans.

An integrated understanding of the physiological mechanisms involved in the genesis of nausea remains lacking. We aimed to describe the psychophysiological changes accompanying visually induced motion sickness, using a motion video, hypothesizing that differences would be evident between subjects who developed nausea in comparison to those who did not. A motion, or a control, stimulus was presented to 98 healthy subjects in a randomized crossover design. Validated questionnaires and a visual analogue scale (VAS) were used for the assessment of anxiety and nausea. Autonomic and electrogastrographic activity were measured at baseline and continuously thereafter. Plasma vasopressin and ghrelin were measured in response to the motion video. Subjects were stratified into quartiles based on VAS nausea scores, with the upper and lower quartiles considered to be nausea sensitive and resistant, respectively. Twenty-eight subjects were exposed to the motion video during functional neuroimaging. During the motion video, nausea-sensitive subjects had lower normogastria/tachygastria ratio and cardiac vagal tone but higher cardiac sympathetic index in comparison to the control video. Furthermore, nausea-sensitive subjects had decreased plasma ghrelin and demonstrated increased activity of the left anterior cingulate cortex. Nausea VAS scores correlated positively with plasma vasopressin and left inferior frontal and middle occipital gyri activity and correlated negatively with plasma ghrelin and brain activity in the right cerebellar tonsil, declive, culmen, lingual gyrus and cuneus. This study demonstrates that the subjective sensation of nausea is associated with objective changes in autonomic, endocrine and brain networks, and thus identifies potential objective biomarkers and targets for therapeutic interventions.

Phase 2 study of a new Hydrofiber dressing for superficial chronic or acute wounds.

OBJECTIVE: To evaluate the safety and performance of MedicelTulle Dressing (MTD) in subjects with chronic or acute wounds left to heal by secondary intention. METHOD: This 28-day, multi-centre, single-arm clinical study was conducted at seven sites in France. Thirty patients with a chronic (n = 20) or acute wound (n = 10) were treated with MTD and gauze as a secondary dressing. Study treatment lasted 28 days or until healing. RESULTS: Mean baseline wound area was 14.8cm2. There were 103 clinic dressing changes and 220 home dressing changes. Seven adverse events were reported in five subjects, including one treatment-related adverse event of dry scab. No adherence was reported for 66% of clinic dressing changes and 53% of home dressing changes. No trauma was reported for 96% of clinic dressing changes. Mean reduction in wound size was 7.0cm2. CONCLUSION: In this study, MTD demonstrated good safety results. Additional study is warranted to confirm the clinical utility of MTD in the management of chronic or acute wounds left to heal by secondary intention.

Efficacy, safety and acceptability of a new two-layer bandage system for venous leg ulcers.

OBJECTIVE: To evaluate the efficacy, tolerability and acceptability of a new two-bandage compression system in the local management of venous or mixed aetiology ulcers predominantly of venous origin. METHOD: This was a prospective non-comparative open label phase III clinical study. Forty-two patients were recruited from 12 centres. Inclusion criteria included ulcers with at least 50% granulation tissue, a surface area of 2-20 cm2, an ulcer duration of 1-24 months, an ankle circumference of less than 28 cm, and no history of deep vein thrombosis in the three months before enrolment. The primary endpoint was reduction in ulcer surface area, and secondary endpoints were the evolution of leg oedema and patient comfort. During the six-week follow-up, patients underwent weekly clinical assessments and their ulcer surface area was measured by planimetry and photography every alternate week. RESULTS: The mean ulcer surface area at inclusion was 7 +/- 6 cm2. The mean surface reduction after six weeks was 58.5%, with 24% of the treated wounds healing in a mean time of 25.9 +/- 9.46 days. The patients considered that the new compression system had a better effect on quality of life, evaluated by parameters such as pain, heat, itching and general comfort, than the system worn before entry into the study. Patient concordance with the new system was excellent and 86% of leg ulcers improved or healed after six weeks. Local tolerance was considered very good. CONCLUSION: This new two-bandage compression system is effective and well accepted by patients.

A prospective study on the use of a non-adhesive gelling foam dressing on exuding leg ulcers.

OBJECTIVE: This non-comparative phase II study aimed to evaluate the safety and performance of a non-adhesive gelling foam dressing (GFD-N) in leg ulcer management. METHOD: Forty-six subjects with moderately to heavily exuding leg ulcers were treated with a regimen including GFD-N. Dressings were changed at least every seven days for four weeks or until healing. RESULTS: Mean GFD-N wear time was 3.2 days per subject. Mean wound area decreased from 10.1 cm2 at baseline to 5.1 cm2 at four weeks (p<0.001) and healed in five subjects (11%). The surrounding skin improved or remained stable in all but one subject. When compared with pre-study dressings, ulcer pain decreased for GFD-N, both with the dressing in place (p<0.001) and on dressing removal (p<0.001). Of final investigator ratings for 45 subjects, most were 'excellent' for ease of application (89%), ease of removal (96%), conformability (67%) and overall performance (58%). Five subjects experienced adverse events; none were serious or dressing-related. CONCLUSION: This small study demonstrates that GFD-N was safe, effective and convenient for wound healing, exudate management, pain/comfort and ease of use.

Compression and peri-ulcer skin in outpatients' venous leg ulcers: results of a French survey.

OBJECTIVE: To evaluate concordance with compression therapy in ambulatory patients with venous leg ulcers. METHOD: This was a prospective observational survey conducted in general practice. Consecutive patients with venous leg ulcers about to receive a non-adherent primary dressing and with no contraindication to compression bandaging were selected. At the inclusion visit, size, local aspect of the ulcer and the peri-ulcer skin were scored. Patients were asked about concordance with compression and were given a questionnaire to be completed at home. If patients were seen at a three-week follow-up visit, ulcer and peri-ulcer characteristics and concordance were reassessed. RESULTS: A total of 2842 patients were included, of whom 2532 were re-evaluated at three weeks and 1397 (49%) returned their questionnaire. A compression bandage was already available for 62.9% of these patients, and 62.7% said they used it on a daily basis, 23.3% wore it one or two days per week and 13.7% wore it irregularly or never. There was a statistically significant correlation between concordance with compression and ulcer and peri-ulcer skin severity scores (p < 0.001 and p = 0.042 respectively). At the follow-up visit, concordance with compression therapy improved (80.1% were wearing it regularly). Ulcer, peri-ulcer skin severity scores and ulcer size were significantly lower (p < 0.001) when concordance with compression therapy was good. However, 65.6% of patients considered applying compression very difficult; 45% considered it very unaesthetic and 23% judge wearing it to be very painful, while 9% thought it may worsen their ulcer. CONCLUSION: On a short-term basis, concordance with compression can be substantially improved by simple measures with a clear favourable consequence on both ulcer status and peri-ulcer skin aspect when a non-adherent primary dressing is used. However, the acceptability of compression to patients is poor, and continuous effort is required to convince them of its importance.

Leg ulcers and the Urgocell Non-Adhesive wound dressing.

The objectives of this clinical trial were to evaluate the efficacy and tolerance of the Urgocell Non-Adhesive (NA) dressing in the local management of venous or mixed leg ulcers. The study was a non-comparative, prospective, multicentre (15 centres) phase III, clinical trial. The studied population was composed of non-immunodepressed adults presenting a venous or mixed leg ulcer, uninfected, non-cancerous, present for less than 18 months. Patients were followed up for 6 weeks with a weekly visit, including a clinical examination, area tracings and photographs. Evaluation by nursing staff and patients was performed at each dressing changed. Forty-three patients were included, presenting a leg ulcer with a mean surface area of 10.7 cm2. The surface area was reduced by a mean of 38% after 6 weeks of treatment. Four local adverse events were deemed to be related to the tested treatment and acceptability was noted very good for patients and nursing staff. The Urgocell NA dressing, combined with compression therapy, promoted the healing of the chronic wounds under study. The good tolerance and acceptability of the tested dressing were greatly appreciated.

Prognostic factors for venous ulcer healing in a non-selected population of ambulatory patients.

OBJECTIVE: To identify wound prognostic indicators in a non-selected patient population with leg ulcers. METHOD: This was a prospective observational survey involving 151 physicians. Ambulatory patients with venous leg ulcers were treated with a non-adherent foam dressing and usual leg ulcer management. At follow-up after three to six weeks, ulcer healing parameters and local treatment tolerability were recorded and concordance with compression therapy was validated. RESULTS: A > or = 40% reduction in the largest wound length was selected as an indicator of a favourable healing outcome. A total of 330 patients were included and seen at follow-up. The mean largest wound length was 4.9 +/- 3.6 cm. A > or = 40% decrease in this parameter was noted in 178 patients. Dressing acceptability and tolerability were excellent. Compression therapy, while heterogeneous among physicians, was used regularly and applied correctly (by patients and practitioners) in 81.2% of patients. Predictors for not reaching the main outcome were the presence of an arterial lower limb disease, an ulcer duration of more than three months and an initial ulcer length of 10 cm or more. Linear regression showed that old age and a high body mass index were independent predictors of a poor outcome. CONCLUSION: Clinical indicators such as simple ulcer length measurement and ulcer duration may help physicians to detect patients with a prognosis of poor healing.

Efficacy of Class 1 elastic compression stockings in the early stages of chronic venous disease. A comparative study.

AIM: The aim of this study was to compare the efficacy of Class 1 (10-15 mmHg at the ankle) compression stockings with that of reference stockings of identical appearance during the early stages of chronic venous disease (CVD). METHODS: A prospective multi-center randomized double blind crossover study was conducted on 2 groups of female patients presenting with CVD with a CEAP classification of C1-3SEp As1-5. The efficacy of Class 1 compression stockings was evaluated with respect to global painful discomfort (visual analog scale), each symptom of CVD, the daily behavior of the patient, changes in the volume of the legs, and the functioning of the venous pump (D-PPG). The compliance level of each patient was measured by the number of days that she wore the stockings for at least 6 hours, and tolerance was measured by the reporting of ensuing undesirable events. RESULTS: A total of 125 patients were included in the study and were analyzed for intent to treat. Highly significant differences favoring Class 1 compression stockings were noted with respect to both global painful discomfort and each symptom of CVD with the exception of paresthesia. The relief of symptoms that resulted from the use of the Class 1 compression stockings was twice that which resulted from the use of the reference stockings. Differences that favored the Class 1 compression stockings were also observed with respect to 2 quality-of-life factors (mood and daily work activity). Good compliance in the use of the stockings was reported for 95% of the patients, and tolerance was higher for the Class 1 compression stockings group than for the reference group. CONCLUSION: The regular wearing of Class 1 graduated elastic compression stockings during a 15-day period results in a significant improvement in the symptomatology of early-stage chronic venous disease, i.e., in the relief of global painful discomfort as well as in quality-of-life criteria. A high level of patient compliance in the wearing of the stockings was achieved in this study.