New Treatment of Wound Healing With Allogenic Acellular Human Skin Graft: Preclinical Assessment and In Vitro Study.

BACKGROUND: Nonhealing wounds can be a major clinical problem. Impaired wound healing is often related to massive tissue injury, concomitant wound healing deficiencies (chronic wounds), burn injury, or congenital conditions. We propose a novel biological dressing as an alternative surgical approach. The dressing is a form of an allogenic human skin graft equivalent with further use of allogeneic stem cells classified as an advanced therapy medicinal product. This new allogenic acellular human skin graft has been specifically developed to address the clinical indications for dressing wound lesions and promoting tissue repair in specific rare genetic diseases. METHODS: This case report illustrates the use of an acellular human skin allograft seeded with multipotent stem cells in the treatment of tissue injuries (burns), congenital conditions, and chronic wounds. Donor-tissue processing yields an acellular dermal matrix with integral collagen bundling and organization, as well as an intact basement membrane complex. RESULTS: Preclinical observations show prolonged viability of acellular human skin grafts with multipotent stem cells. This was confirmed with histological and electron-microscopic evaluation of biopsies, which demonstrated host-cell infiltration and neovascularization of the biological dressing. Moreover, the dressings were characterized by low immunogenicity, as confirmed by histology exam and T-cell proliferation assays in vitro. CONCLUSION: Our data confirmed the safety and efficacy of the evaluated acellular human skin grafts, which may be used in patients with rare diseases, such as epidermolysis bullosa, burn injuries, and chronic wounds.

Health economics for treatment of diabetic foot ulcers: a cost-effectiveness analysis of eight skin substitutes.

AIM: Skin substitutes are frequently used to treat chronic diabetic foot ulcers (DFU), and many different options are available. While the clinical efficacy of many products has been evaluated, a comprehensive cost-effectiveness analysis comparing the most popular skin substitutes and using the most recent cost data has been lacking. METHODS: This study compared eight skin substitutes using published efficacy rates combined with the Centers for Medicare and Medicaid Services (CMS) 2018 cost data. The study criteria resulted in the inclusion of seven studies that described efficacy rates for treatment of DFUs using the skin substitutes. RESULTS: The results revealed wide discrepancies between these skin substitutes for the costs of treatments and healing rates in hospital outpatient departments and physician office settings. Healing rates for 12 and 16 weeks ranged from 28% to 68%, while the average cost for treating one DFU varied from $2001 to $14,507 and $1207 to $8791 in the hospital outpatient department and physician's office setting, respectively. The estimated patient share of costs for treating a single DFU ranged from $400 to $2901 and $241 to $1758 in the hospital outpatient department and physician's office setting, respectively. Most importantly, the estimated number of wounds healed out of 100 DFUs per $1000 expenditure with each patient ranged from 3.9-26.5 DFUs in the hospital outpatient department, and 4.3-36.4 DFUs in the physicians' office setting. CONCLUSIONS: This study revealed that the costs of a skin substitute itself did not necessarily correlate with its healing efficacy. These results provide a comprehensive cost-effectiveness analysis to enable integrated health-care systems, health professionals and reimbursement payers to make informed value decisions when treating DFUs.

A Comparison of Three Dressing Methods for Pilonidal Sinus Surgery Wound Healing.

OBJECTIVE: To evaluate the effect of different dressing methods on the wound healing process after pilonidal sinus surgery. METHODS: In this clinical trial, 60 patients undergoing pilonidal sinus surgery were randomly assigned to one of three groups. In the first group, hydrogel or alginate and hydrocolloid compounds were used as a standard occlusive dressing method. A modified dressing method was used for the second group, in which transparent hydrocolloid films were replaced by Vaseline gauze. The third group was treated using gauze swabs soaked in normal saline. The length and depth of the studied wounds were recorded once a week for a month. During dressing changes, patient pain was recorded using an 11-point numeric rating scale. The collected data were analyzed by descriptive and inferential statistical methods. RESULTS: There was a significant reduction in wound length after 2 weeks in all three groups (P < .05), and the pain experienced by the first and second groups was significantly lower than the third group. However, the modified method used for the second group was associated with a lower cost. CONCLUSIONS: Considering the beneficial results of using modern dressings for wound healing and reducing the severity of associated pain, providers may want to consider using modified wound dressings after pilonidal sinus surgery. Study authors recommend that providers receive training on how to use these products.

Membrana de Biocelulose no tratamento de: lesões cutâneas com perda de pele, úlceras venosas e arteriais, lesões por pressão, queimaduras de segundo grau e áreas doadoras de enxerto / Biocellulose membrane, non-treatment of: lesoes cutaneous lesion, venous and artery ulcers, pressure lesions, second-gravity burns and gumming areas of enxerto

CONTEXTO: Este relatório tem por objetivo avaliar as evidências científicas atualmente disponíveis acerca da eficácia e segurança do curativo Nexfill® para tratamento de várias indicações, sendo por definição uma parecer de múltiplas tecnologias. A demanda solicitou a incorporação no tratamento de lesões cutâneas com perda de pele, queimaduras de segundo grau, úlceras venosas e arteriais e lesões por pressão, sem presença de infecção. Os princípios básicos do tratamento de feridas e queimaduras baseiam-se em limpeza, desbridamento, redução da dor e tratamento da infecção ou redução da colonização. Outro princípio importante da terapia tópica de feridas é a oclusão com coberturas. TECNOLOGIA: Curativo de membrana de biocelulose (Nexfill®). INDICAÇÃO: Lesões cutâneas com perda de pele, úlceras venosas e arteriais, lesões por pressão, queimaduras de segundo grau e áreas doadoras de enxerto. PERGUNTA: O uso do curativo de membrana de biocelulose Nexfill® é eficaz, seguro e custo-efetivo no tratamento de lesões cutâneas com perda de pele, queimaduras de segundo grau, úlceras venosas e arteriais e lesões por pressão quando comparado ao tratamento convencional? EVIDÊNCIAS CIENTÍFICAS: Foi realizada pelos pareceristas uma busca nas bases de dados primárias Medline, Scielo e Lilacs, por ensaios clínicos randomizados e estudos observacionais. As evidências e recomendações foram classificadas seguindo a recomendação GRADE. Não foram encontrados estudos de intervenção ou observacionais com o curativo de biocelulose Nexfill®, sendo então selecionados para avaliar a eficácia e segurança estudos nos quais a tecnologia utilizada para o tratamento foi a membrana de biocelulose produzida a partir da biossíntese de Gluconacetobacter xylinus, semelhante ao curativo Nexfill®. A maior parte dos estudos selecionados é para o tratamento das úlceras venosas e queimaduras, apresentando resultados de redução de 28% no tempo de cicatrização das feridas e menor número de trocas quando comparado ao tratamento padrão. Destes, nenhum evento adverso foi relatado devido ao uso da membrana de biocelulose. QUALIDADE DAS EVIDÊNCIAS: a qualidade das evidências foi classificada de moderada a baixa. AVALIAÇÃO ECONÔMICA: Os custos e tempo de cicatrização são menores com o curativo de biocelulose comparado ao curativo padrão (sulfadiazina de prata) para a cicatrização completa das úlceras venosas de membros inferiores. Mantendo-se o intervalo de troca estima-se, portanto uma dominância da intervenção Nexfill® sobre o tratamento padrão. AVALIAÇÃO DE IMPACTO ORÇAMENTÁRIO: o impacto orçamentário foi estimado em uma economia de R$ 56.640.466,46, ao longo de 5 anos, com a incorporação da tecnologia Nexfill® para tratamento de úlceras venosas de perna, com redução no tempo de cicatrização e menor número de trocas. CONSIDERAÇÕES FINAIS: O balanço entre a qualidade limitada das evidências e os benefícios demonstrados é favorável, em especial pela redução do tempo até a cicatrização completa da lesão. A recomendação é fraca a favor da incorporação. RECOMENDAÇÃO PRELIMINAR DA CONITEC: Os membros do Plenário da CONITEC, em sua 60ª reunião ordinária, recomendaram que a matéria fosse enviada à Consulta Pública com manifestação preliminar não favorável à criação de novo procedimento na tabela SIGTAP. No entanto, esclarece-se que a deliberação não inviabilizará a utilização da tecnologia em análise. Ou seja, será possível a sua utilização dentro da gama de procedimentos de curativos já disponíveis no SIGTAP. CONSULTA PÚBLICA: Por meio da Consulta Pública nº 57/2017 entre os dias 25/10/2017 e 13/11/2017 foram recebidas 24 contribuições, sendo 10 técnico-científicas e 14 contribuições de experiência ou opinião. Após apreciação das contribuições encaminhadas pela Consulta Pública, a Conitec entendeu que não houve argumentação suficiente para alterar sua recomendação inicial. DELIBERAÇÃO FINAL: Os membros da CONITEC presentes na 62ª reunião do plenário do dia 06/12/2017 deliberaram por unanimidade não recomendar a criação do novo procedimento - Curativo de biocelulose para o tratamento de pacientes com lesões de pele e queimaduras de 2ºgrau, ferimentos com perda de pele e área doadoras de enxerto. Foi assinado o Registro de Deliberação nº 309/2017. A recomendação será encaminhada para decisão do Secretário da SCTIE. DECISÃO: Não criar procedimento específico para o uso do curativo de biocelulose para o tratamento de pacientes com lesões de pele e queimaduras de 2º grau, ferimentos com perda de pele e área doadoras de enxerto no âmbito do Sistema Único de Saúde - SUS, dada pela Portaria nº 5, publicada no DOU nº 18, do dia 25 de janeiro de 2018, seção 1, pág. 123.(AU)

Custo-efetividade do uso do curativo de colágeno e alginato no tratamento de áreas doadoras de enxerto de pele de espessura parcial / Cost-effectiveness of collagen wound dressing with alginate for the treatment of split-thickness skin graft donor sites / El costo-efectividad de la utilización del apósito de colágeno con alginato en el tratamiento de las áreas donadoras de injerto de espesor parcial de la piel

OBJETIVO: Avaliar a utilização do curativo de colágeno e alginato de cálcio em áreas doadoras de enxerto de pele parcial em relação ao curativo com gaze tipo rayon. MÉTODO: Foi realizado estudo clínico prospectivo na Divisão de Cirurgia Plástica e Queimaduras do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, no período de 2010 a 2015. Os pacientes foram selecionados de forma consecutiva e distribuídos de forma randomizada em três grupos de acordo com o tratamento usado na área doadora: rayon exposto, embebido em soro fisiológico 0,9%; rayon coberto por gaze de algodão estéril e atadura; curativo formado por 90% de colágeno bovino associado a 10% de alginato de cálcio. Foram analisados comparativamente os seguintes parâmetros: dor, tempo para epitelização, tempo de internação e custos. RESULTADOS: Foram estudados 30 pacientes, com idade variando de 12 e 60 anos. Quinze desses pacientes tiveram suas áreas doadoras cobertas com o curativo de colágeno e alginato de cálcio, os quais apresentaram redução dos níveis álgicos em 79,5% (p<0,01), menor tempo de internação e epitelização, média de 5,8 dias (p<0,01) e redução dos custos hospitalares em cerca de 47% (p<0,01) em comparação com o curativo de rayon. Nenhum apresentou infecção na área doadora. CONCLUSÃO: O curativo de colágeno e alginato apresentou melhor custo-benefício em relação ao rayon para cobertura de áreas doadoras, com importante redução da dor, do tempo de epitelização e de internação e dos custos.

OBJECTIVE: To evaluate the use of collagen calcium-alginate dressing for split-thickness skin graft donor sites in comparison with rayon dressing. METHODS: A prospective clinical study was conducted at Divisão de Cirurgia Plástica e Queimaduras do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo from 2010 to 2015. Patients were selected consecutively and randomly allocated into three groups according to the treatment used on the donor site: rayon soaked in 0.9% saline; rayon covered with sterile cotton gauze and bandage; 90% bovine collagen with 10% calcium-alginate dressing covered with transparent polyurethane film. Following parameters was comparatively analyzed: pain, time to epithelialization, length of stay and costs. RESULTS: We studied 30 patients, ranging from 12 to 60 years of age. Fifteen of these patients had their donor sites covered with collagen calcium-alginate dressing, which showed pain reduction of 79.5% (p<0.01), shorter hospital stay and epithelialization, average of 5.8 days (p<0.01) and reduction in hospital costs about 47% (p<0.01) in comparison with rayon dressing. None presented infection in the donor site. CONCLUSION: Collagen calcium-alginate dressing showed better cost-benefit than rayon to cover donor sites, with significant reduction of pain, epithelialization time, length of stay and costs.

Objetivo: Evaluar la utilización del apósito de colágeno con alginato de calcio en áreas donadoras de injerto de espesor parcial de la piel en relación a la curación con gasa tipo rayón. Método: Se realizó un estudio clínico prospectivo en la División de Cirugía Plástica y Quemadura, del Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo en el período de 2010 a 2015. Los pacientes fueron seleccionados de forma consecutiva y distribuida de forma aleatorizada en tres grupos de acuerdo con el tratamiento utilizado en la área donadora: rayón expuesto, embebido en suero fisiológico 0,9%; Rayón cubierto por gasa de algodón estéril y vendaje; apósito formado por un 90% de colágeno bovino asociado al 10% de alginato de calcio. Se analizaron comparativamente los siguientes parámetros: dolor, tiempo para epitelización, tiempo de internación y costos. Resultados: Se estudiaron 30 pacientes, con edad variando de 12 a 60 años. Quince de estos pacientes tuvieron sus áreas donantes cubiertas con el apósito de colágeno con alginato de calcio, los cuales presentaron reducción de los niveles álgicos en el 79,5% (p<0,01), menor tiempo de internación y epitelización, media de 5.8 (p<0,01) y reducción de los costos hospitalarios en 47% (p<0,01) en comparación con el apósito de rayón. Ninguno presentó infección en el área donante. Conclusión: El apósito de colágeno con alginato presentó mejor costo-efectividad en relación al rayón para cobertura de áreas donantes, con importante reducción del dolor, del tiempo de epitelización, de internación y de los costos

[Application of combination of xenoskin with delayed microskin graft in extensively burned patients].

OBJECTIVE: To observe clinical effects of combination of acellular porcine skin with delayed microskin graft on extensively burned patients.
 Methods: Forty extensively burned patients were assigned into a treatment group and a control group. In the treatment group, 20 patients were covered with acellular porcine skin after escharectomy, and the delayed microskin grafting was performed 5 days later. In the control group, 20 patients were covered with allograft skin combined with microskin graft after escharectomy. The cure rate, the graft survival rate, wound healing time and cost per 1% wound were observed.
 Results: The cure rate for the 2 groups was the same (90%), and wound healing time was similar between the two groups (P>0.05). The graft survival rate in the treatment group was higher than that in the control group (P<0.05), and cost per 1% wound in the treatment group was less than that in the control group (P<0.05).
 Conclusion: The combination of acellular porcine skin with delayed microskin graft is an effective method to treat extensively burned patients, and it provides an ideal substitute for allograft skin combined with microskin graft.

Assessment of Chicken-Egg Membrane as a Dressing for Wound Healing.

OBJECTIVES: To examine the efficacy of the folk remedy of chicken-egg membrane dressing on wound healing. DESIGN: Full-thickness excisional wounds were created on 14 male Sprague-Dawley rats in 2 separate trials. Each animal received 2 wounds on the upper back. One wound was untreated, and the other was dressed with chicken-egg membrane to assess its impact on wound healing. Half of the rats received egg membrane treatment on the inferior wound, whereas the other half received egg membrane treatment on the superior wound. Membrane replacement, wound debridement, and imaging were done on days 5, 8, and 10 and then imaging continued on days 12, 14, 16, 18, and 20 of the experiment. Healing rate was measured based on the wound area over the 20 days of the experiment. RESULTS: The wounds dressed with chicken-egg membrane had a significantly (P < .01) faster rate of healing compared with the control at the early stages of healing between days 0 and 5. This group healed 21% faster during this early phase, compared with the control group. Overall, however, wound healing rates were indistinguishable from days 5 to 20. CONCLUSION: Chicken-egg membrane dressing significantly improves healing of cutaneous wounds in the early stages of wound healing.

A comparison of Biobrane™ and cadaveric allograft for temporizing the acute burn wound: Cost and procedural time.

INTRODUCTION: In many circumstances early burn excision and autografting is unsafe or even impossible. In these situations, skin substitute dressings can be utilized for temporary wound coverage. Two commonly used dressings for this purpose are cadaveric allograft and Biobrane™. MATERIALS AND METHODS: Five year retrospective cohort study evaluating upper extremity burns treated with temporary wound coverage (Biobrane™ or allograft). The primary outcome was to determine the impact choice of wound coverage had on operative time and cost. The secondary outcome was the need for revision of upper extremity debridement prior to definitive autografting. RESULTS: 45 patients were included in this study: 15 treated with cadaveric allograft and 30 treated with Biobrane™ skin substitute. Biobrane™ had a significantly lower procedure time (21.12 vs. 54.78 min per %TBSA excised, p=0.02) and cost (1.30 vs. 2.35 dollars per minute per %TBSA excised, p=0.002). Both techniques resulted in 2 revisions due to complications. CONCLUSION: Biobrane™ is superior to cadaveric allograft as a temporizing skin substitute in the acute burn wound, both in terms of procedure time and associated cost. We believe that this is largely due to the relative ease of application of Biobrane™. Furthermore, given its unique characteristics, Biobrane™ may serve as a triage and transport option for severe burns in the military and mass casualty settings.

Immediate effects of the initial FDA notification on the use of surgical mesh for pelvic organ prolapse surgery in medicare beneficiaries.

AIMS: Prompted by increased reports of complications with the use of mesh for pelvic organ prolapse (POP) surgery, the FDA issued an initial public health notification (PHN) in 2008. We proposed to determine if the numbers of POP cases augmented with surgical mesh performed in U.S. Medicare beneficiaries changed relative to this PHN. METHODS: Using administrative healthcare claims for beneficiaries enrolled in the U.S. Medicare program from 2008 to 2009, we identified women who underwent POP surgery with and without surgical mesh by procedural and diagnosis coding. In addition to comparing cases with and without mesh, we also calculated rates (number of cases per 100,000 female beneficiaries) and compared these relative to the timing of the PHN. RESULTS: We identified 104,185 POP procedures, of which 27,839 (26.7%) included mesh material and 76,346 (73.3%) did not. Between the last three quarters of 2008 and the first three of 2009, the rates of mesh cases increased (40.3-42.1, P < 0.001) and those without mesh decreased (115.5-111.4, P < 0.001). Inpatient procedures decreased and outpatient procedures increased for both those with and without mesh augmentation. For inpatient procedures, the relative use of biologic graft and synthetic mesh material did not vary over the study period. CONCLUSIONS: A substantial number of Medicare beneficiaries underwent mesh POP procedures in 2008-2009. However, despite the PHN cautioning about potential mesh complications, the numbers of mesh cases continued to rise in the immediate period after the PHN.

Biologic meshes in perineal reconstruction following extra-levator abdominoperineal excision (elAPE).

Recent improvements in the outcome for low rectal cancer have focused on the reconstruction of the perineal defect following greater acceptance of the need for a wider perineal excision encompassing the levator ani complex. In this article we look at the use of biologic materials to close the perineal defect and compare this with the use of other techniques.

The role of biologics in pelvic floor surgery.

The advent of laparoscopic surgery and with it Laparoscopic Ventral Mesh Rectopexy (LVMR) has revolutionised the management of internal/external rectal and vaginal vault prolapse. These procedures have traditionally been performed with synthetic meshes. Biologics have gained a prominent role over the last decade in LVMR as well as perineal procedures for rectocoele and cystocoele repair. We examine the existing literature on the use of biologics in pelvic floor surgery comparing this with literature on synthetic mesh for the key outcomes of infection rates, bowel/sexual function and recurrence.

Amniotic membrane transplantation in the treatment of chronic lower limb ulcers.

INTRODUCTION: Approximately 1% of the general population have venous or arterial lower limb ulcers. These lesions can be treated with biological skin substitutes such as cadaver skin or tissue-engineered skin equivalents, but treatment fails in 25% of cases, resulting in pain and loss of patient autonomy, as well as increased morbidity and health care costs. In the treatment of corneal ulcers, amniotic membrane has been shown to have antimicrobial and bacteriostatic properties, and to protect the wound without eliciting an immune response. The same properties have been reported in the treatment of burns and postthrombotic ulcers. OBJECTIVES: To assess the effectiveness of amniotic membrane transplantation in the treatment of refractory chronic leg ulcers. PATIENTS AND METHODS: Amniotic membrane was grafted onto 4 refractory ulcers in 3 patients. The mean time required for partial and complete re-epithelialization was calculated by measuring the wound area at weeks 0, 4, 8, 12, and 16. Pain intensity was assessed at the same intervals using a visual analog scale. RESULTS: Complete wound re-epithelialization was achieved for 1 ulcer by week 8; in the other 3 cases, there was a 50% reduction in size compared to baseline. At week 16, the mean reduction in wound size for the 4 ulcers was 81.93%. The corresponding reduction in pain intensity was 86.6%. No adverse effects were observed. CONCLUSIONS: Amniotic membrane transplantation might be an effective alternative for the treatment of refractory chronic vascular ulcers on the lower limbs.

Acute assessment and management of burn injuries.

Burns are ubiquitous injuries in modern society, with virtually all adults having sustained a burn at some point in their lives. The skin is the largest organ of the body, basically functioning to protect self from non-self. Burn injury to the skin is painful, resource-intensive, and often associated with scarring, contracture formation, and long-term disability. Larger burns are associated with morbidity and mortality disproportionate to their initial appearance. Electrical and chemical burns are less common injuries but are often associated with significant morbidity.

[Cost-benefit analysis of amniotic membrane transplantation for venous ulcers of the legs that are refractory to conventional treatment]. / Estudio coste-beneficio del trasplante de membrana amniótica para úlceras venosas de extremidades inferiores refractarias a tratamiento convencional.

BACKGROUND: Standard compression therapy for venous ulcers of the legs does not promote healing. Although autografting accelerates tissue repair, it is difficult to use in patients with concomitant diseases or when multiple grafts are required. The amniotic membrane has been used as a covering material and promotes epithelialization, making it a good potential treatment option when autografts are not indicated. OBJECTIVES: To analyze the literature on the safety and efficacy of amniotic membrane grafting and compare the cost of currently available grafts (autografts, amniotic membrane grafts, and biocompatible skin substitutes) to promote tissue repair in venous ulcers. MATERIAL AND METHODS: A systematic review of the literature on the use of amniotic membrane grafts for the treatment of venous ulcers was performed up to 2010. A cost-minimization analysis of direct healthcare costs was then performed (at 3 and 6 months). A sensitivity analysis was performed to confirm the stability of the results. RESULTS: Only 1 study addressing safety and efficacy was identified. The cost-minimization analysis showed that autografts are always the least-expensive option (€ 1053 compared with € 1825 for amniotic membrane grafts and € 5767 for biocompatible skin grafts). At 6 months, however, amniotic membrane grafts would have cost € 6765 less than the use of biocompatible skin substitutes. CONCLUSIONS: Despite having excellent therapeutic potential for the re-epithelialization of venous ulcers that do not respond to conventional treatment, amniotic membrane transplant remains an experimental therapy. Autograft is the most efficient treatment but amniotic membrane graft is less expensive than the use of biocompatible skin substitutes.

Assessment of amniotic and polyurethane membrane dressings in the treatment of burns.

As allograft and xenografts are not available in Islamic countries, amniotic membrane seems to be an effective alternative in the management of deep burns. Its proven bioactivities and modest price suggest that it might be superior to synthetic dressings. Forty-six patients were enrolled in this randomized, controlled clinical trial conducted in the Burn Unit at Suez Canal University Hospital, Ismailia, Egypt. All age groups and both gender were included in the study. Only patients with less than 50% total body surface area burned were included, thus minimizing the dropouts in both groups. All were either second or third degree. These patients were randomly assigned either to group I: amniotic membrane (Biomembrane) dressing, or group II: polyurethane membrane (Tegaderm) dressing. Those in group I demonstrated a significantly lower rate of infection and required less frequent dressing changes than those in group II. They also sustained less electrolyte and albumin loss. The rate of healing in the amniotic membrane group was significantly faster than in the polyurethane group. Furthermore, pain was significantly less when Biomembrane was used. Based on these findings, we recommend the use of lyophilized gamma-irradiated amniotic membrane as an effective alternative for allograft and xenografts in Islamic countries and the Jewish population.

Assessment of the efficacy of the rectovaginal button fistula plug for the treatment of ileal pouch-vaginal and rectovaginal fistulas.

BACKGROUND: The treatment of rectovaginal and ileal pouch-vaginal fistulas remains a challenging problem for the colorectal surgeon. The aim of this study was to assess the short-term efficacy of the new Surgisis Biodesign rectovaginal button fistula plug in patients with such fistulas. METHODS: Between May 2008 and September 2008, patients with confirmed rectovaginal and ileal pouch-vaginal fistulas with backgrounds of inflammatory bowel disease were treated with the button fistula plug. The fistulas were assessed by magnetic resonance imaging and/or examination under anesthesia before the procedure. RESULTS: Twelve patients with a median age of 36 (range, 29-42) years underwent a total of 20 plug insertions. Five patients had confirmed rectovaginal fistulas and seven patients had ileal pouch-vaginal fistulas. At a median follow-up of 15 (interquartile range, 10-21) weeks, 7 of 12 patients (58%) had been treated successfully. Seven of the 20 plugs that were inserted (35%) were successful. This equates to the successful treatment of three of five (60%) of the rectovaginal fistulas, and four of seven (57%) of the ileal pouch-vaginal fistulas. Of the six patients who initially failed, a repeat procedure was performed of which one was successful. Two patients underwent a third repeat procedure, which was again unsuccessful in both cases. The success rate of these eight repeat plug insertions was therefore 12.5%. All plug failures were the result of dislodgement of the plug. There was no morbidity in our series. CONCLUSIONS: The new button fistula plug successfully treated 7 of 12 (58%) rectovaginal and ileal pouch-vaginal fistulas.

An evidence-based model comparing the cost-effectiveness of platelet-rich plasma gel to alternative therapies for patients with nonhealing diabetic foot ulcers.

OBJECTIVE: A cost-effectiveness analysis compared the potential economic benefit of an autologous, platelet-rich plasma (PRP) gel to alternative therapies in treating nonhealing diabetic foot ulcers. DESIGN: An economic model used peer-reviewed data to simulate clinical and cost outcomes and quality-adjusted life-years (QALYs) associated with PRP gel and other treatment modalities. PATIENTS: The model varies rates of healing, recurrence, infection, amputation, death, and associated costs for a hypothetical group of 200,000 patients with full-thickness, nonhealing diabetic foot ulcers for 5 years or until death. MAIN OUTCOME MEASURES: The model simulates the clinical, cost, and QALY outcomes associated with PRP gel versus other modalities in treating nonhealing diabetic foot ulcers over a 5-year period. MAIN RESULTS: The average 5-year direct wound care cost per modality and QALYs were PRP gel, $15,159 (2.87); saline gel, $33,214 (2.70); standard of care, $40,073 (2.65); noncontact kilohertz ultrasound therapy, $32,659 (2.73); human fibroblast-derived dermal substitute, $40,569 (2.65); allogenic bilayered culture skin substitute, $24,374 (2.79); bilayered cellular matrix, $37,340 (2.71); negative pressure wound therapy, $20,964 (2.81); and recombinant human platelet-derived growth factor BB, $47,252 (2.69). CONCLUSION: Use of PRP gel resulted in improved quality of life and lower cost of care over a 5-year period than other treatment modalities for nonhealing diabetic foot ulcers. Although actual treatment outcomes may differ from those modeled, PRP gel represents a potentially attractive treatment alternative for insurers and health care providers to address the cost burden and health effects of nonhealing diabetic foot ulcers.

Clinical and histological safety assessment of rectocele repair using collagen mesh.

AIM: To clinically and histologically evaluate inflammatory response following rectocele repair using porcine collagen mesh. METHODS: Seventeen patients underwent rectocele repair using porcine collagen mesh. Inflammatory response was assessed by clinical and histological inflammatory grading pre- and postoperatively. Postoperative body temperature, complications and hospital stay was compared with 15 patients undergoing posterior colporraphy. RESULTS: Postoperative clinical examination did not demonstrate any inflammatory reaction. There were no significant changes in fibroblast count (P = 0.43), connective tissue density grading (P = 0.54), macrophage count (P = 0.20), inflammatory cell count (P = 0.48), total cell count (P = 0.51), or inflammatory grading (P = 0.87) postoperatively compared with preoperative values. Body temperature was significantly elevated for both the study and control group, although higher for the study group, postoperatively day 1 (P < 0.001). There were no significant differences in hospital stay and postoperative complications. CONCLUSION: Porcine collagen mesh was not associated with an adverse inflammatory response at clinical or histological evaluation and appears to be a safe material when used for rectocele repair.