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.

[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.

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.

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.

[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.

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.

Cost-effectiveness of wound management in France: pressure ulcers and venous leg ulcers.

OBJECTIVES: This study set out to define realistic protocols of care for the treatment of chronic venous leg ulcers and pressure ulcers in France and, by developing cost-effectiveness models, to compare the different protocols of care for the two ulcer groups, enabling a calculation of direct medical costs per ulcer healed in a typical French health insurance plan. METHOD: Clinical outcomes and some treatment patterns were obtained from published literature. Validations of different treatment patterns were developed using an expert consensus panel similar to the Delphi approach. Costs were calculated based on national averages and estimates from the UK and Germany. The models were used to measure costs per healed ulcer over a 12-week period. RESULTS: For both the pressure ulcer and venous leg ulcer models, three protocols of care were identified. For pressure ulcers and venous leg ulcers, the hydrocolloid DuoDERM (ConvaTec, also known as Granuflex in the UK and Varihesive in Germany) was most cost-effective in France. CONCLUSION: The combination of published data and expert consensus opinion is a valid technique, and in this case suggests that treating pressure ulcers and venous leg ulcers with hydrocolloid dressings is more cost-effective than treating them with saline gauze, in spite of the lower unit cost of the latter.

Hanging wet-to-dry dressings out to dry.

Wet-to-dry dressings have been standard procedure for home care wound care patients although research indicates gauze dressings are not an optimal wound care modality for the patient, the clinician, or the healthcare system. Gauze dressings do not effectively support optimal healing and are more labor intensive to use than advanced dressings such as films, foams, hydrocolloids, and hydrogels. This article provides clinicians with the rationale and evidence needed to collaborate with physicians in choosing the most cost-effective wound care products to achieve positive patient outcomes.

Mixed views on wound product.

Wound-care management has developed into a $2 billion market, and some hospitals are turning to Procuren, a product that uses a patient's own blood platelets to stimulate healing. However, some physicians are skeptical that it's the wonder drug that it's portrayed to be.

Amniotic membrane dressing for burns in children. A cheap method of treatment for developing countries.

Ten children aged seven months to eleven years with superficial burns involving (mean) 24% of total body surface were treated with amniotic membrane dressing in a general ward. The result of treatment was compared with that obtained during an earlier (12 months) period using non biological antimicrobial dressing on the same ward. One patient treated with amnion developed pseudomonas wound infection and another required skin grafting. These children spent an average of 31 days in hospital, as compared with 56 days for the control group. It is concluded that amniotic membrane dressing is to be preferred in the treatment of burns in hospitals in poorer countries, because of it's ready availability, ease of preparation and cheapness of storage.