Tolerability and efficacy assessment of an oral collagen supplement for the improvement of biophysical and ultrasonographic parameters of skin in middle eastern consumers.

BACKGROUND: Topical skin care products often do not reach the deeper layers of the skin, and oral hydrolyzed collagen is one of the newest and most popular systemic supplementations for skin rejuvenation. However, there are limited information in case of Middle Eastern consumers OBJECTIVE: The purpose of this study was to evaluate the tolerability and efficacy of an oral collagen supplement for improvement of skin elasticity, hydration, and roughness in Middle Eastern consumers. METHODS AND MATERIALS: It was a 12-week, before-after clinical study, conducted on 20 participants (18 women and 2 men) aged 44.15 ± 5.36 years with skin type III-IV. Skin elasticity parameters (R0, R2, R5, and R7), skin hydration and friction, as well as the thickness and echo density of the dermis, were measured after six and 12 weeks daily intake of the study product, as well as 4 weeks after stopping its use (week 16). Participants' satisfaction was assessed on the basis of their answers to the standard questionnaire, and tolerability of the product was assessed by monitoring the adverse effects. RESULTS: A significant improvement was detected in R2, R5, and skin friction at week 12 (p-values 0.041, 0.012 and <0.01, respectively). At week 16, the values remained at an increased level, which indicates the persistence of the results. The increase of dermis density in week 16 was also significant (p-value = 0.03). Moderate overall satisfaction was reported with the treatment, and a few gastrointestinal complications were reported. CONCLUSION: The study demonstrated that oral collagen peptides could significantly improve the skin elasticity, roughness, and dermis echo density, and they also proved to be safe and well-tolerated.

Cost-effectiveness of using a collagen-containing dressing plus compression therapy in non-healing venous leg ulcers.

OBJECTIVE: To estimate whether collagen-containing dressings could potentially afford the UK's National Health Service (NHS) a cost-effective intervention for the management of non-healing venous leg ulcers (VLUs). METHOD: This was a modelling study performed from the perspective of the UK's NHS. A combination of published clinical outcomes, resource utilisation estimates and utilities for VLUs enabled the construction of a decision model, depicting the management of a chronic VLU with standard care or with a collagen-containing dressing plus compression therapy followed by standard care, over a period of 6 months. The model estimated the incremental cost-effectiveness of the two interventions in terms of the incremental cost per quality-adjusted life year (QALY) gained at 2015/16 prices. RESULTS: The treatment of VLUs of >6 months' duration with a collagen-containing dressing plus compression therapy followed by standard care, instead of standard care, is expected to increase the probability of healing from 0.11 to 0.49 by 6 months and increase health-related quality of life at 6 months from 0.331 to 0.373 QALYs per patient. Additionally, treatment with a collagen-containing dressing plus compression therapy followed by standard care has the potential to reduce management costs by 40% over 6 months when compared with standard care (from £6328 to £3789 per patient). CONCLUSION: Within the study's limitations, including a collagen-containing dressing into a standard care protocol compared with standard care potentially affords the NHS a cost-effective (dominant) treatment since it improves outcomes for less cost.

Cost-effectiveness analysis of a sealing hemostat patch (HEMOPATCH) vs standard of care in cardiac surgery.

BACKGROUND: A recent randomized controlled trial showed that patients undergoing ascending aorta surgery treated with HEMOPATCH to control bleeding had a significantly better hemostasis success rate than with dry or wet gauze compression or similar standard of care (SOC). OBJECTIVE: To compare the cost-effectiveness using two different agents for hemostasis (HEMOPATCH vs dry or wet gauze compression or similar SOC) in cardiac surgery from the European hospital perspective. METHODS: A literature-based cost-effectiveness model estimating average cost per successful hemostasis event was developed based on the hemostasis efficacy difference (HEMOPATCH = 97.6%, SOC = 65.8%, p < .001). Additional clinically significant end-points studied in the trial (blood transfusions and surgical revisions) were also analyzed. It was assumed that each surgery utilized two units of HEMOPATCH (dimensions of 4.5 × 9 cm) and two units of SOC. Product acquisition costs for HEMOPATCH and SOC were included along with outcome-related costs derived from the literature and inflation-adjusted to 2017 EUR and GBP. Results are presented for an average hospital with an annual case load of 574 cardiac surgeries. One-way and probabilistic sensitivity analyses were performed. RESULTS: Considering only product acquisition cost, HEMOPATCH had an incremental cost-effectiveness ratio (ICER) of €1,659, €1,519, €1,623, and £1,725 per hemostasis success when compared to SOC for Italy, Spain, France, and the UK, respectively. However, when considering the cost and potential difference in the frequency of transfusions and revisions compared to SOC, the use of HEMOPATCH was associated with an annual reduction of six revisions and 60 transfusions, improving the ICER to €1,440, €1,222, €1,461, and £1,592, respectively. Sensitivity analysis demonstrated model robustness. CONCLUSIONS: This analysis supports the use of HEMOPATCH over SOC in cardiac surgery in European hospitals to improve hemostasis success rates and potential cost offsets from reduced transfusions, complications, and surgical revisions.

[Assessment of changes in the lesions sizes and the incidence of complete epithelialization during the treatment of diabetic foot syndrome over a period of 4 weeks (multicenter study)]. / Otsenka dinamiki ploshchadi rany i chastoty sluchaev polnoi epitelizatsii pri lechenii sindroma diabeticheskoi stopy (rezul'taty mnogotsentrovogo issledovaniya).

AIM: To assess the effectiveness of the collagen biomaterial in treatment process in patients with DFS. MATERIAL AND METHODS: 71 patients 30-80 y.o. with diabetic foot syndrome of varying severity were included in prospective multicenter study. Patients were randomized into two homogeneous groups: control group (n=35) - standard therapy, other 36 patients (main group) were additionally treated with medical device (MD) Collost in accordance with the instructions for use. RESULTS: Biomaterial Collost using in complex treatment of diabetic foot syndrome resulted in more rapid and effective healing of the ulcer. The treatment success increased from 43% to 72%. Complete epithelialization was achieved by 2.6 times more rapidly in conjunction with reduction the incidence of unsuccessful treatment results by 4.1 times.

[Topical haemostatic agents in neurosurgery].

Haemostasis is of fundamental significance in neurosurgery, and insufficient control of bleeding is associated with morbidity and mortality. Topical haemostatic agents play an important role, as the characteristics of neuronal tissue limit the use of classical surgical haemostasis techniques. Appropriate choice of agent depends on the location and type of bleeding, but also on knowledge of the products' mechanisms of action, indications, price and accessibility. Biological products are superior to the mechanical in efficacy but require more preparation and are significantly more cost-intensive.

In-vivo quantitative assessment of the therapeutic response in a mouse model of collagen-induced arthritis using 18 F-fluorodeoxyglucose positron emission tomography.

Mouse collagen-induced arthritis (CIA) is the most commonly used animal model to investigate underlying pathogenesis of autoimmune arthritis and to demonstrate the therapeutic efficacy of novel drugs in autoimmune arthritis. The conventional read-outs of CIA are clinical score and histopathology, which have several limitations, including (i) subjected to observer bias; and (ii) longitudinal therapeutic efficacy of a new drug cannot be determined. Thus, a robust, non-invasive, in-vivo drug screening tool is currently an unmet need. Here we have assessed the utility of 18 F-fluorodeoxyglucose positron emission tomography (18 F-FDG) as an in-vivo screening tool for anti-inflammatory drugs using the mouse CIA model. The radiotracer 18 F-FDG and a PET scanner were employed to monitor CIA disease activity before and after murine anti-tumour necrosis factor (TNF)-α antibody (CNTO5048) therapy in the mouse CIA model. Radiotracer concentration was derived from PET images for individual limb joints and on a per-limb basis, and Spearman's correlation coefficient (ρ) was determined with clinical score and histology of the affected limbs. CNTO5048 improved arthritis efficiently, as evidenced by clinical score and histopathology. PET showed an increased uptake of 18 F-FDG with the progression of the disease and a significant decrease in the post-treatment group. 18 F-FDG uptake patterns showed a strong correlation with clinical score (ρ = 0·71, P < 0·05) and histopathology (ρ = 0·76, P < 0·05). This study demonstrates the potential of 18 F-FDG PET as a tool for in-vivo drug screening for inflammatory arthritis and to monitor the therapeutic effects in a longitudinal setting.

Norfloxacin-loaded collagen/chitosan scaffolds for skin reconstruction: Preparation, evaluation and in-vivo wound healing assessment.

Biomaterial scaffolds are versatile tools as drug carrier for treatment of wounds. A series of norfloxacin-loaded scaffolds were synthesized for treatment of wounds by combining collagen with two different types of chitosan using freeze-drying technique. Subsequently, scaffolds were screened in terms of morphology, water absorption and retention capacity, biodegradation, ex-vivo bioadhesive strength, in-vitro drug release biological compatibility, X-ray diffractometry, differential scanning calorimetry as well as in-vivo evaluation. The results indicate that the scaffold mechanical strength is dependent on the type of used chitosan. The prepared scaffolds contained interconnected porous architecture. The scaffolds had high water uptake and retention capacity with extended biodegradation rate. Scaffolds prepared with chitosan HCl showed superior bioadhesive strength compared to those prepared with low molecular weight chitosan. All scaffolds showed almost 100% drug release within 24h. As identified by the terahertz pulsed imaging measurements, there is single scaffold area with the same concentration. After 28 days of wound dressing with selected norfoloxacin-loaded or unloaded collagen/chitosan scaffolds in Albino rats, it was found that the tissue regeneration time was fast compared to non-treated wounds. Furthermore, the drug-loaded scaffolds showed normal structure of an intact epidermal layer as well as the underlying dermis as revealed by histopathological studies. The obtained results suggest that the investigated norfloxacin-loaded collagen/chitosan scaffold is a potential candidate for skin regeneration application.

Malar augmentation with a polymethylmethacrylate-enhanced filler: assessment of a 12-month open-label pilot study.

BACKGROUND: Most filler procedures in the United States are performed with hyaluronic acid (HA) derivatives. Artefill (Suneva Medical, Inc, San Diego, California), the only polymethylmethacrylate (PMMA)-enhanced dermal filler approved by the US Food and Drug Administration (FDA), has been well tolerated by patients for treatment of nasolabial folds and has a safety profile similar to other approved fillers. OBJECTIVES: The authors investigate the safety and efficacy of Artefill for malar augmentation. METHODS: This prospective, multisite, open-label study included a total of 24 patients with age-related lipoatrophy. Only patients with mild to moderate lipoatrophy were considered candidates for treatment. Artefill was injected in the supraperiosteal layer of the malar region, at a maximum volume of 6 mL (3 mL/side). Touch-up injections were performed at weeks 4 and 6, up to a maximum total volume of 8.8 mL. Standardized assessments of results were made at 2, 6, and 12 months. Outcome measures included the Global Aesthetic Improvement Scale (GAIS), change in malar lipoatrophy grade, and patient satisfaction. Standardized photographs of each patient were collected. RESULTS: Average patient age was 48 ± 5 years. Average volume of injections was 5.55 ± 1.87 mL. Based on both the patient- and physician-rated GAIS, 95.8% of study participants were reported as being "improved" or "very much improved." The change in malar lipoatrophy grade was significantly improved from baseline to 1 year by 0.96 ± 0.98 (P < .0003). Patients also reported high levels of satisfaction, with 87.5% being "satisfied" or "very satisfied." There were no reported adverse safety events in the study. CONCLUSIONS: Artefill demonstrated improvement in malar atrophy with a high level of patient satisfaction and an excellent safety profile. The absence of any adverse events in our study patients was notable, and we believe this is a result of the uniform nature of the PMMA particles in the Artefill and the strict and sterile manner in which this PMMA dermal filler is produced.

Acellular dermal matrices in secondary aesthetic breast surgery: indications, techniques, and outcomes.

Acellular dermal matrices are integrally involved in the majority of expander-implant reconstructions and complex hernia repairs today, and they are now making their way into secondary aesthetic breast surgery. The number of revisional breast surgery cases has continued to increase as the materials and repair techniques have improved. The aesthetic outcome bar is constantly being raised, and the complexity of patient deformities often requires additional tissues to achieve a successful repair. The most common complications in breast augmentation are reviewed, along with indications and some current repair techniques, general principles, and specific caveats to help plastic surgeons deal with these complex and challenging patient problems utilizing acellular dermal matrices.

The use of human acellular dermal matrix for the correction of secondary deformities after breast augmentation: results and costs.

BACKGROUND: Secondary breast deformities following breast augmentation constitute some of the most challenging and difficult problems to correct. Although the application and efficacy of human acellular dermal matrix in breast reconstruction has been previously reported, there is little information in the literature relating to its indications, results, or cost in aesthetic breast surgery. METHODS: This study retrospectively reviewed a single surgeon's experience in correcting secondary deformities with human acellular dermal matrix after breast augmentation from 2005 to 2009. A total of 23 patients (38 breasts) were included in the study. RESULTS: There were 28 breasts with surface irregularities and 22 breasts with implant malposition (12 had both). On average, 1.13 sheets of human acellular dermal matrix were used per breast per operation. At the authors' institution, this material equates to a cost to the patient of $3536 to $4856 per breast (depending on sheet size and thickness). Twenty of 23 patients (87 percent) [32 of 38 breasts (84 percent)] had improvement in their breast deformity after breast revision surgery. Three patients (six breasts) needed another cosmetic breast operation before the end of the follow-up period: two because of persistent surface irregularities and one with a request for larger implants. One patient (3 percent) had an infection in one breast, requiring removal of the human acellular dermal matrix. CONCLUSIONS: Human acellular dermal matrix is a useful and safe adjunct for correction of contour deformities after breast augmentation. Its high cost, however, may be a deterrent to widespread use in self-pay patients.

An economic evaluation of surgery versus collagen injection for the treatment of female stress urinary incontinence.

OBJECTIVE: To use data from a randomized controlled trial and update an earlier economic evaluation of surgery versus collagen injection for the treatment of female stress urinary incontinence (SUI). MATERIALS AND METHODS: A decision tree model was developed using probabilities of success and complications from a randomized controlled trial. Resource use and cost data were taken from the earlier economic evaluation. The primary outcome was treatment success, which was defined as a negative 24 hour PAD test given 1 year post-treatment. The evaluation was conducted from the 'healthcare system' perspective and separate analyses were undertaken for Ontario and Québec. Sensitivity analyses were used to examine uncertainty in probabilities and costs. RESULTS: Surgery was generally more costly and more successful than collagen injection. Incremental cost effectiveness ratios indicated that the healthcare system would incur an additional cost of $121.08 to $341.35 per additional patient that was successfully treated with surgery. Sensitivity analyses showed that surgery would be less costly and more successful than collagen injection if the postoperative length of hospital stay was reduced to 1 day. Surgery might also be more cost effective than collagen injection if the number of injections used to treat patients were to increase beyond two for treatment successes and four for treatment failures. CONCLUSIONS: Collagen injection is an outpatient procedure without risk of significant morbidity or complications. However, this does not readily translate into a clear cost effective advantage relative to surgery. In some cases, surgery may be more cost effective than collagen injection in the treatment of female SUI.

Assessment of recovery time for the collagen products Dermicol-P35 27G and 30G.

BACKGROUND: Dermicol-P35 27G and 30G are purified advanced collagen dermal fillers that are effective and well tolerated for cosmetic procedures. OBJECTIVE: The primary objectives of this study were to: (1) document recovery time and return to daily activities after treatment with Dermicol-P35 27G, 30G, or both; and (2) assess the immediate adverse effects of these products and monitor their time to resolution. METHODS: In all, 30 patients were treated with Dermicol-P35 27G, 30G, or both in nasolabial folds, lips, corners of the mouth, vermillion border, marionette lines, or a combination of these and monitored for 7 days. Comfort with resuming daily routine, adverse events, and satisfaction with results were documented by patients in diaries. The clinician assessed aesthetic improvement and rated satisfaction with results. RESULTS: The majority of patients (63.4%) were very comfortable or comfortable returning to their daily routine immediately postprocedure. Most patients (86.7%) participated in normal work or social events within 2 days of treatment. Adverse events were mild to moderate and were resolved or tolerable by day 7. The clinician assessed that most patients had between 50% and 100% improvement over baseline for all procedures at all time points. Clinician and patients were very satisfied or satisfied with aesthetic results at days 2 and 7 postprocedure. LIMITATIONS: The limitations of this study were the small number of patients, the assessment of short-term results, and the lack of touch-up injections. CONCLUSIONS: Treatment with Dermicol-P35 27G, 30G, or both allowed for rapid return to daily activities and produced only transient and tolerable adverse events.

Triple-drug transcatheter arterial chemoembolization in unresectable hepatocellular carcinoma: assessment of survival in 124 consecutive patients.

OBJECTIVE: The objective of our study was to describe survival outcome in 124 patients with unresectable hepatocellular carcinoma treated with triple-drug transcatheter arterial chemoembolization (TACE) using doxorubicin, cisplatin, and mitomycin C using a standardized regimen. MATERIALS AND METHODS: One hundred twenty-four patients underwent TACE using a standardized triple-drug regimen. Embolization was performed using subselective coaxial embolization technique. Fifty-six patients (group 1) received triple-drug TACE in conjunction with a nonpermanent embolic agent, microfibrillar collagen (Avitene), and 68 patients (group 2) had triple-drug TACE with a permanent embolic agent, Embosphere Microspheres. RESULTS: Twenty-eight patients underwent liver transplantation after TACE, and survival in these patients was significantly longer than those who did not receive a transplant (p < or = 0.001). The mean survival for the no-transplant group (n = 96) was longer in patients with Child-Pugh class A cirrhosis than in those with Child-Pugh class B cirrhosis (30.3 +/- 2.92 [standard error] vs 11.6 +/- 2.84 months, respectively; p < 0.001), in those with Okuda stage I versus stage II disease (31.4 +/- 3.03 vs 17.4 +/- 3.16 months; p = 0.002), and in those with a pre-TACE bilirubin level of less than 2.5 mg/dL (42.75 micromol/L; 28.3 +/- 2.75 vs 13.2 +/- 3.83 months; p = 0.007). Improved survival was seen in the no-transplant patients receiving TACE with the permanent embolic agent (group 2) than in those receiving TACE with the nonpermanent agent (group 1) out to 30 months (p = 0.002). Complications occurred in 16 patients (12.9%). The 30-day mortality was 2.4%. CONCLUSION: Patients with hepatocellular carcinoma who underwent triple-drug TACE followed by liver transplantation showed the longest survival. Patients who did not receive a transplant and were treated with triple-drug TACE with a permanent embolic agent showed longer survival to 30 months after TACE than those receiving a nonpermanent embolic agent.

Reversible vs. nonreversible fillers in facial aesthetics: concerns and considerations.

Soft-tissue augmentation of the face is an increasingly popular cosmetic procedure. In recent years, the number of available filling agents has also increased dramatically, improving the range of options available to physicians and patients. Understanding the different characteristics, capabilities, risks, and limitations of the available dermal and subdermal fillers can help physicians improve patient outcomes and reduce the risk of complications. The most popular fillers are those made from cross-linked hyaluronic acid (HA). A major and unique advantage of HA fillers is that they can be quickly and easily reversed by the injection of hyaluronidase into areas in which elimination of the filler is desired, either because there is excess HA in the area or to accelerate the resolution of an adverse reaction to treatment or to the product. In general, a lower incidence of complications (especially late-occurring or long-lasting effects) has been reported with HA fillers compared with the semi-permanent and permanent fillers. The implantation of nonreversible fillers requires more and different expertise on the part of the physician than does injection of HA fillers, and may produce effects and complications that are more difficult or impossible to manage even by the use of corrective surgery. Most practitioners use HA fillers as the foundation of their filler practices because they have found that HA fillers produce excellent aesthetic outcomes with high patient satisfaction, and a low incidence and severity of complications. Only limited subsets of physicians and patients have been able to justify the higher complexity and risks associated with the use of nonreversible fillers.

[Assessment of bovine biomaterials containing bone morphogenetic proteins bound to absorbable hydroxyapatite in rabbit segmental bone defects]. / Avaliação de biomateriais bovinos contendo proteínas morfogenéticas ósseas absorvidas a hidroxiapatita em defeitos ósseos segmentares em coelhos.

PURPOSE: To evaluate the osteo-regenerative capacity of two proprietary bone grafting materials, using a segmental defect model in both radial diaphyses of rabbits. METHODS: The right defect was filled with pooled bone morphogenetic proteins (pBMPs) bound to absorbable ultrathin powdered hydroxyapatite (HA) mixed with inorganic and demineralized bone matrix and bone-derived collagen, derived from bovine bone (Group A). The left defect was filled with bovine demineralized bone matrix and pBMPs bound to absorbable ultrathin powdered HA (Group B). In both groups, an absorbable membrane of demineralized bovine cortical was used to retain the biomaterials in the bone defects, and to guide the tissue regeneration. The rabbits were euthanized 30, 90 and 150 days after surgery. Radiographic, tomographic and histologic evaluations were carried out on all specimens. RESULTS: At 30 days, the demineralized cortical bone cover was totally resorbed in both groups. HA was totally resorbed from Group A defects, whereas HA persisted in Group B defects. A prominent foreign body reaction was evident with both products, more pronounced in sections from Group B. At 90 days, the defects in Group B exhibited more new bone than Group A. However, at 150 days after surgery, neither treatment had stimulated complete repair of the defect. CONCLUSION: The partial bone healing of the segmental defect occurred with low or none performance of the biomaterials tested.

Assessment of bovine biomaterials containing bone morphogenetic proteins bound to absorbable hydroxyapatite in rabbit segmental bone defects

PURPOSE: To evaluate the osteo-regenerative capacity of two proprietary bone grafting materials, using a segmental defect model in both radial diaphyses of rabbits. METHODS: The right defect was filled with pooled bone morphogenetic proteins (pBMPs) bound to absorbable ultrathin powdered hydroxyapatite (HA) mixed with inorganic and demineralized bone matrix and bone-derived collagen, derived from bovine bone (Group A). The left defect was filled with bovine demineralized bone matrix and pBMPs bound to absorbable ultrathin powdered HA (Group B). In both groups, an absorbable membrane of demineralized bovine cortical was used to retain the biomaterials in the bone defects, and to guide the tissue regeneration. The rabbits were euthanized 30, 90 and 150 days after surgery. Radiographic, tomographic and histologic evaluations were carried out on all specimens. RESULTS: At 30 days, the demineralized cortical bone cover was totally resorbed in both groups. HA was totally resorbed from Group A defects, whereas HA persisted in Group B defects. A prominent foreign body reaction was evident with both products, more pronounced in sections from Group B. At 90 days, the defects in Group B exhibited more new bone than Group A. However, at 150 days after surgery, neither treatment had stimulated complete repair of the defect. CONCLUSION: The partial bone healing of the segmental defect occurred with low or none performance of the biomaterials tested.

OBJETIVO: Avaliar a capacidade osteo-regenerativa de dois biomateriais utilizando um modelo de defeito segmentar efetuado nas diáfises do rádio de coelhos. MÉTODOS: O defeito direito foi preenchido com pool de proteínas morfogenéticas ósseas (pBMPs) e hidroxiapatita em pó ultrafina absorvível (HA) combinada com matriz óssea inorgânica desmineralizada e colágeno, derivados do osso bovino (Grupo A). O defeito esquerdo foi preenchido com matriz óssea desmineralizada bovina com pBMPs e hidroxiapatita em pó ultrafina absorvível (Grupo B). Em ambos os defeitos utilizou-se membrana reabsorvível de cortical bovina desmineralizada para reter os biomateriais no defeito ósseo e guiar a regeneração tecidual. Os coelhos foram submetidos à eutanásia aos 30, 90 e 150 dias após a cirurgia. Foram efetuados exames radiográficos, tomográficos e histológicos em todos os espécimes. RESULTADOS: Aos 30 dias de pós-cirúrgico, o osso cortical desmineralizado foi totalmente reabsorvido em ambos os grupos. A HA tinha reabsorvido nos defeitos do Grupo A, mas persistiu nos do Grupo B. Uma reação de corpo estranho foi evidente com ambos os produtos, porém mais pronunciada no Grupo B. Aos 90 dias os defeitos do grupo B tinham mais formação óssea que os do Grupo A. Entretanto, aos 150 dias após a cirurgia, nenhum tratamento havia promovido o completo reparo do defeito. CONCLUSÃO: Os biomateriais testados contribuíram pouco ou quase nada para a reconstituição do defeito segmentar.

The efficacy of Apligraf in the treatment of diabetic foot ulcers.

Diabetic foot ulcerations can be a devastating complication of diabetes, causing prolonged hospitalization and significant morbidity. Previously identified risk factors include peripheral neuropathy, foot deformities, and poor wound healing due to an altered wound environment. Despite appropriate treatment, many diabetic ulcers fail to heal. Bioengineered tissue, such as Apligraf (Graftskin; Organogenesis Inc., Canton, Mass.), has been effectively and safely used to increase the incidence of complete wound closure and decrease the healing time. Studies have demonstrated that Apligraf works through the delivery of growth factors and cytokines to the chronic wound environment.

Cost effectiveness of local collagen-gentamicin as prophylaxis for sternal wound infections in different risk groups.

OBJECTIVES: In a randomized trial addition of local collagen-gentamicin in the sternal wound reduced the rate of sternal wound infection (SWI) to about 50% compared to intravenous prophylaxis alone. The aim of the present study was to evaluate the economic rationale for its use in every-day clinical practice. This includes the question whether high-risk groups that may have particular benefit should be identified. DESIGN: For each patient with SWI in the trial the costs attributable to the SWI were calculated. Risk factors for SWI were identified and any heterogeneity of the effect of the prophylaxis examined. RESULTS: The mean cost of a SWI was about 14500 Euros. A cost effectiveness analysis showed that the prophylaxis was cost saving. The positive net balance was even higher in risk groups. Assignment to the control group, overweight, diabetes, younger age, mammarian artery use, left ventricular ejection fraction <35% and longer operation time were independent risk factors for infection. CONCLUSION: The addition of local collagen-gentamicin to intravenous antibiotic prophylaxis was dominant, i.e. resulted in both lower costs and fewer wound infections.