Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital-acquired pressure ulcers: a pragmatic noncommercial multicentre randomized open-label parallel-group medical device trial.

BACKGROUND: Silicone adhesive multilayer foam dressings are used as adjuvant therapy to prevent hospital-acquired pressure ulcers (PUs). OBJECTIVES: To determine whether silicone foam dressings in addition to standard prevention reduce the incidence of PUs of category 2 or worse compared with standard prevention alone. METHODS: This was a multicentre, randomized controlled medical device trial conducted in eight Belgian hospitals. At-risk adult patients were centrally randomized (n = 1633) to study groups based on a 1 : 1 : 1 allocation: experimental groups 1 (n = 542) and 2 (n = 545) - pooled as the treatment group - and the control group (n = 546). The experimental groups received PU prevention according to hospital protocol, and a silicone foam dressing on the relevant body sites. The control group received standard of care. The primary endpoint was the incidence of a new PU of category 2 or worse at the studied body sites. RESULTS: In the intention-to-treat population (n = 1605), PUs of category 2 or worse occurred in 4·0% of patients in the treatment group and 6·3% in the control group [relative risk (RR) 0·64, 95% confidence interval (CI) 0·41-0·99, P = 0·04]. Sacral PUs were observed in 2·8% and 4·8% of the patients in the treatment group and the control group, respectively (RR 0·59, 95% CI 0·35-0·98, P = 0·04). Heel PUs occurred in 1·4% and 1·9% of patients in the treatment and control groups, respectively (RR 0·76, 95% CI 0·34-1·68, P = 0·49). CONCLUSIONS: Silicone foam dressings reduce the incidence of PUs of category 2 or worse in hospitalized at-risk patients when used in addition to standard of care. The results show a decrease for the sacrum, but no statistical difference for the heel and trochanter areas.

Towards an international language for incontinence-associated dermatitis (IAD): design and evaluation of psychometric properties of the Ghent Global IAD Categorization Tool (GLOBIAD) in 30 countries.

BACKGROUND: Incontinence-associated dermatitis (IAD) is a specific type of irritant contact dermatitis with different severity levels. An internationally accepted instrument to assess the severity of IAD in adults, with established diagnostic accuracy, agreement and reliability, is needed to support clinical practice and research. OBJECTIVES: To design the Ghent Global IAD Categorization Tool (GLOBIAD) and evaluate its psychometric properties. METHODS: The design was based on expert consultation using a three-round Delphi procedure with 34 experts from 13 countries. The instrument was tested using IAD photographs, which reflected different severity levels, in a sample of 823 healthcare professionals from 30 countries. Measures for diagnostic accuracy (sensitivity and specificity), agreement, interrater reliability (multirater Fleiss kappa) and intrarater reliability (Cohen's kappa) were assessed. RESULTS: The GLOBIAD consists of two categories based on the presence of persistent redness (category 1) and skin loss (category 2), both of which are subdivided based on the presence of clinical signs of infection. The agreement for differentiating between category 1 and category 2 was 0·86 [95% confidence interval (CI) 0·86-0·87], with a sensitivity of 90% and a specificity of 84%. The overall agreement was 0·55 (95% CI 0·55-0·56). The Fleiss kappa for differentiating between category 1 and category 2 was 0·65 (95% CI 0·65-0·65). The overall Fleiss kappa was 0·41 (95% CI 0·41-0·41). The Cohen's kappa for differentiating between category 1 and category 2 was 0·76 (95% CI 0·75-0·77). The overall Cohen's kappa was 0·61 (95% CI 0·59-0·62). CONCLUSIONS: The development of the GLOBIAD is a major step towards a better systematic assessment of IAD in clinical practice and research worldwide. However, further validation is needed.

Analysis of potential factors affecting microbiological cultures in tissue donors during procurement.

During the procurement of musculoskeletal grafts contamination may occur. As this might be detrimental for the acceptor, it is important to know which variables influence this occurrence and to alter procurement protocols accordingly. From 2004 to 2012 we gathered information on 6,428 allografts obtained from 291 donors. Using a multiple regression model we attempted to determine the factors that influence the contamination risk during procurement. We used the following variables: cause of death, type of hospital (i.e. university hospital vs. general hospital), previous blood vessel donation, previous organ donation, donor age, time between death and the start of the procurement, duration of the procurement, number of people attending the procurement and the number of procured grafts. The multiple regression model was only able to explain 5 % of the variability of the used outcome variable. None of the variables examined appear to have an important influence on the contamination risk.

Inhibiting connexin channels protects against cryopreservation-induced cell death in human blood vessels.

OBJECTIVES: Cryopreserved blood vessels are being increasingly employed in vascular reconstruction procedures but freezing/thawing is associated with significant cell death that may lead to graft failure. Vascular cells express connexin proteins that form gap junction channels and hemichannels. Gap junction channels directly connect the cytoplasm of adjacent cells and may facilitate the passage of cell death messengers leading to bystander cell death. Two hemichannels form a gap junction channel but these channels are also present as free non-connected hemichannels. Hemichannels are normally closed but may open under stressful conditions and thereby promote cell death. We here investigated whether blocking gap junctions and hemichannels could prevent cell death after cryopreservation. MATERIALS AND METHODS: Inclusion of Gap27, a connexin channel inhibitory peptide, during cryopreservation and thawing of human saphenous veins and femoral arteries was evaluated by terminal deoxynucleotidyl transferase dUTP nick end labelling (TUNEL) assays and histological examination. RESULTS: We report that Gap27 significantly reduces cell death in human femoral arteries and saphenous veins when present during cryopreservation/thawing. In particular, smooth muscle cell death was reduced by 73% in arteries and 71% in veins, while endothelial cell death was reduced by 32% in arteries and 51% in veins. CONCLUSIONS: We conclude that inhibiting connexin channels during cryopreservation strongly promotes vascular cell viability.

[Emergency guidelines for cosmetic procedures and esthetic skin treatment: recommendations of the medical establishment]. / Nood aan regelgeving inzake toestellen voor cosmetische toepassing en cosmetische huidbehandeling: Aanbevelingen van de Hoge Gezondheidsraad.

The use of devices for cosmetic treatment and esthetic skin treatments has increased in recent years. Some of these treatments, especially those that pass the dermo-epidermal barrier, can cause complications and secondary effects. In Belgium, there is almost no legislation concerning this type of treatment. Therefore, the Belgian Health Council has advised in a recent publication of January 2011, that there is an urgent need for adequate regulation concerning the use of devices for cosmetic treatment and esthetic skin treatment. The Council suggests to start up an evaluation commission, and also to have strict guidelines about the training needed for professionals who do this kind of treatments. Inspections by a competent authority should control the adherence to the forthcoming legislation.

Effect of a sustained silver-releasing dressing on ulcers with delayed healing: the CONTOP study.

OBJECTIVE: To compare the effect of the sustained silver-releasing foam dressing Contreet Foam (ColoplastA/S) with local best practice (LBP) on delayed healing ulcers using a real-life setting. METHOD: A total of 619 patients with ulcers of varying aetiologies were treated for four weeks with either the silver foam dressing or LBP. RESULTS: Wound area was reduced by 50% with the silver foam and 34% with LBP Less slough and maceration, a faster reduction in exudate level and more positive wound progress was achieved with the silver foam. In addition, exudate handling, ease of use, odour and pain improved. Less time was spent on dressing changes, and mean wear time was longer for the silver foam (3.1 days) than for LBP (2.1 days). All differences were statistically significant (p < 0.05). The silver foam dressing outperformed all of the other dressing categories including moist wound healing products and other silver dressings. CONCLUSION: This large-scale comparative real-life study shows that the silver foam dressing supports faster healing of delayed healing wounds.

A prospective multicenter study of the efficacy and tolerability of cryopreserved allogenic human keratinocytes to treat venous leg ulcers.

Allogeneic human keratinocyte cultures have been used to treat burn wounds, donor sites, and chronic skin ulcers with some success. Cryopreservation of these cultures allows for the production of large standardized batches that are readily available for use. The aim of the study presented in this report was to study effects of cryopreserved cultured allogenic human keratinocytes (CryoCeal) on chronic lower extremity wounds. Parameters were measured to study efficacy, tolerability, pain associated with chronic wounds, and quality of life of patients. Twenty-seven patients with hard-to-heal venous leg ulcers received a maximum of 9 applications of CryoCeal in a prospective, uncontrolled multicenter study lasting 48 weeks. Eleven out of 27 patients (41%; 95% CI: 22%-61%) had complete wound closure within 24 weeks (1 week). The time required for complete wound closure in these 11 patients ranged from 4.1 to 24.9 weeks. Only 1 patient had recurrence of the ulcer at 48 weeks. Local (wound) pain scores decreased from a mean of 2.5 at baseline to 0.9 at week 24. Fifty percent of the patients attained a pain score of 0 after 12 weeks and remained stable at this score until the end of the study. Overall, the patient quality of life was better at week 24, compared to baseline values. The treatment was well tolerated, and wound infection was the most frequently occurring adverse event.

Genetic linkage between the collagen type VII gene COL7A1 and pretibial epidermolysis bullosa with lichenoid features.

Pretibial epidermolysis bullosa is a rare form of dominant dystrophic epidermolysis bullosa. The disease was diagnosed after considerable delay in a large Belgian family and was remarkable for its late age at onset and its misleading clinical presentation in the proband, which strongly resembled keratosis lichenoides chronica. Both recessively and dominantly inherited forms of dystrophic epidermolysis bullosa have been shown to be linked to the collagen type VII gene, COL7A1. Two-point linkage analysis with two intragenic polymorphisms (PvuII, AluI) in COL7A1 was performed. Strong genetic linkage between the disease in this family and COL7A1 was demonstrated by a lod score of 4.45 (theta = 0) for the AluI polymorphism. The observed intrafamilial variability of clinical phenotypes contradicts the presently proposed classification of dominantly inherited dystrophic epidermolysis bullosa.

Skin organ culture model to test the toxicity of polyoxyethylene networks.

Films of polyoxyethylene network were prepared from two types of triethoxysilane-terminated prepolymers. In this way, films of polyoxyethylene network with possible applications in the biomedical field could be made easier. To test their biocompatibility, these networks were added to organ cultures of adult human skin and embryonic chicken skin. A rapid toxic effect was observed, especially with the urethane-linked network. Enzymatical degradation of the network by enzymes in the culture medium might be responsible for the formation of toxic metabolites. Testing of related chemical compounds in our in vitro assay suggested that the formation of a silane group with an amino terminal is most likely to be responsible for the toxic effects observed.

Artificial skin: past, present and future.

The integrity of the skin should be restored as soon as possible whenever the skin gets wounded. Recent research has revealed some of the complex pathways in wound healing. Based on this knowledge, researchers have been looking for better skin substitutes to treat difficultly healing or large wounds. Some of these highly sophisticated wound dressings, also known as bio-dressings, contain material of human or animal origin, e.g. cultured skin cells. Although the ideal skin substitute has not been established yet, the currently available bio-dressings help clinicians close difficultly healing skin wounds.

Morphological effects of serotonin and ketanserin on embryonic chick skin in vitro.

Cell and organotypical cultures are used to study the direct effect of serotonin and of ketanserin, a serotonin antagonist, on dermal and epidermal cells of embryonic chick skin. Ketanserin stimulates the increase in cell number and inhibits the differentiation, whereas serotonin stimulates differentiation and inhibits the increase in cell number.

In vitro culture of chick down feather bulbi: a tool to obtain proliferating and differentiating keratinocytes in an organotypic structure.

Chick down feather bulbi can be cultured in different culture systems. Morphological analysis and 3H-thymidine incorporation measurements prove that the majority of cells are viable epithelial cells.

Topical class I corticosteroids in 10 patients with bullous pemphigoid: correlation of the outcome with the severity degree of the disease and review of the literature.

BACKGROUND: Treatment of bullous pemphigoid (BP) with systemic immunosuppressive agents, in particular with systemic corticosteroids, has many long-term side-effects. A dozen reports were published regarding the efficacy of topical corticosteroids in the treatment of bullous pemphigoid. OBJECTIVE: To evaluate the efficacy of potent class I topical corticosteroids in relation to the affected body surface area (BSA) in patients with bullous pemphigoid and to review the literature. METHODS: An open prospective trial with 10 patients with BP with measurement of the affected BSA. Treatment protocol consisted of three steps: potent class I topical corticosteroid treatment, systemic tetracyclines and systemic corticosteroids. Follow-up period was between 24 and 72 months. RESULTS: Our study suggests a correlation between the success rate of topical corticosteroid treatment and the body surface area initially affected: all patients with an affected BSA of less than 20% healed with topical treatment only. The patients with more than 40% affected BSA needed systemic treatment with steroids. CONCLUSION: Topical class I corticosteroids seem to be effective in healing lesions of BP, especially if less than 20% of the BSA is affected. This study comprises only 10 patients, making further studies necessary to draw definite conclusions.

Dose-response curve of the effects of serotonin and ketanserin on the functional morphology of skin in vitro.

A cumulative dose-response curve of the effects of serotonin and its 5-HT2 receptor antagonist ketanserin in embryonic chick skin has been set up using morphological analysis and incorporation of 3H-thymidine as parameters. The resemblance between the results of the morphological analysis and those of the functional analysis was striking. From the results of these experiments, we could deduce new arguments in favor of the hypothesis that a 5-HT2 receptor is involved in the effects of serotonin and ketanserin in embryonic chick skin observed in vitro.

Effects of serotonin and ketanserin on the functional morphology of chick down feather bulbi in vitro.

Chick feather bulbi cultured in vitro showed an increased DNA synthesis and a delayed keratinization after treatment with ketanserin, a serotonin2 antagonist with wound-healing properties. In contrast, serotonin stimulates keratinization of the keratinocytes in the bulbus.

Direct effects of serotonin, and 5-HT2, alpha 1 and H1 receptor-antagonists on embryonic chick skin in vitro: a morphological and functional study.

Ketanserin (K), a 5-HT2, alpha 1 and H1 receptor antagonist, at a concentration of 5 micrograms/ml inhibits keratinisation, but increases DNA-, collagen and glycosaminoglycan (GAG) synthesis in embryonic chick skin in vitro. On the other hand, serotonin (S) at a concentration of 10 micrograms/ml stimulates keratinisation and does not enhance DNA, collagen and GAG synthesis. 5 nM doses of ketanserin and serotonin give analogous results. The effects of other 5-HT2-receptor antagonists (e.g. BW 501 and cinanserin) are comparable to those of K, whereas prazosin (an alpha 1 receptor antagonist) and pyrilamin (an H1 receptor antagonist) do not show any effect on embryonic chick skin in vitro.