Clinical and cost efficacy of advanced wound care matrices in the treatment of venous leg ulcers: a systematic review.

BACKGROUND: Venous leg ulcers (VLUs) are hard-to-heal, recurrent and challenging to treat. Advanced wound care matrices (AWCMs) have been developed to supplement conventional therapies. These costly AWCMs warrant careful comparison as healthcare expenditures are subjected to increasing scrutiny. AIM: This study was designed to compare AWCMs in their ability to heal VLUs and their cost efficacy through a systematic review of randomised controlled trials (RCTs). METHOD: An organised search of Medline, Cochrane Library, Central and CINAHL databases identified RCTs that compared AWCMs to standard compression therapy in the healing of VLUs. Bias was assessed using the Effective Public Health Practice Project (EPHPP) Quality Assessment Tool for Quantitative Studies. Eight studies analysing bilayered skin substitute (BSS) (Apligraf), dehydrated human amnion/chorion membrane (dHACM) (Epifix), human fibroblast-derived dermal substitute (HFDDS) (Dermagraft), extracellular wound matrix (ECM) (Oasis), advanced matrix (AM) (Talymed) and matrix wound dressing (MWD) (Promogran) met the inclusion criteria. RESULTS: Four studies reported significant improvement over standard therapy: BSS, dHACM, ECM and AM. Incremental cost per additional successful treatment was determined for each trial, ranging from $2593 (MWD) to $210,800 (HFDDS). CONCLUSION: Our consolidated analysis of eight major RCTs of AWCMs in the treatment of VLUs revealed a great variation in clinical and cost efficacy among these products. The included trials were inconsistent in methodology, and these limitations should be noted, but, in the absence of RCTs to compare these products, our systematic review may serve as a guide for practitioners who seek to optimise wound healing while considering cost efficacy.

Wound closure in patients with DFU: a cost-effectiveness analysis of two cellular/tissue-derived products.

OBJECTIVE: Determine the cost-effectiveness of extracellular matrix (ECM) relative to human fibroblast-derived dermal substitute (HFDS) on diabetic foot ulcer (DFU) wound closure. METHOD: Outcomes data were obtained from a 12-week, randomised, clinical trial of adults aged 18 years or older diagnosed with type 1 or type 2 diabetes with a DFU. Patients were treated with either ECM or HFDS treatment. A two-state Markov model (healed and unhealed) with a 1-week cycle length was developed using wound-closure rates from the trial to estimate the number of closed-wound weeks and the expected DFU cost per patient. Results were recorded over 12 weeks to estimate the number of closed-wound weeks per treatment and the average cost to achieve epithelialisation (primary outcome). The perspective of the analysis was that of the payer, specifically the Centers for Medicare and Medicaid Services. No cost discounting was performed because of the short duration of the study. RESULTS: The study consisted of 26 patients, with 13 in each group. In the ECM group, 10 wounds closed (77%), with an average closure time of 36 days; 11 wounds closed in the HFDS group (85%), with an average closure time of 41 days. There was no significant difference between these results (p=0.73). Over 12 weeks, the expected cost per DFU was $2522 (£1634) for ECM and $3889 (£2524) for HFDS. Patients treated with HFDS incurred total treatment costs that were approximately 54% higher than those treated with ECM. Sensitivity analyses revealed that the total cost of care for two applications of HFDS was more costly than eight applications of ECM by approximately $500 (£325). CONCLUSION: In patients with DFU, ECM yielded similar clinical outcomes to HFDS but at a lower cost. Health-care providers should consider ECM as a cost-saving alternative to HFDS. DECLARATION OF INTEREST: A.M. Gilligan, and C.R. Waycaster, are employees of Smith & Nephew Inc.. This study was funded by Smith & Nephew Inc.. A.L. Landsman, reports no conflicts of interest.