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-
1.
Yannas, IV, JF Burke, M Warpehoski, et al. :Prompt, long-term functional replacement of skin. .Trans Am Soc Artif Intern Organs 27::19. ,1981. .
-
2.
Baldwin, C, M Potter, E Clayton, et al. :Topical negative pressure stimulates endothelial migration and proliferation: a suggested mechanism for improved integration of Integra. .Ann Plast Surg 62::92. ,2009. .
-
3.
Greenwood, J, M Amjadi, B Dearman, et al. :Real-time demonstration of split skin graft inosculation and Integra dermal matrix neovascularization using confocal laser scanning microscopy. .Eplasty 9::e33. ,2009. .
-
4.
Heimbach, D, A Luterman, J Burke, et al. :Artificial dermis for major burns: a multi-center randomized clinical trial. .Ann Surg 208::313. ,1988. .
-
5.
Heimbach, DM, GD Warden, A Luterman, et al. :Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment. .J Burn Care Rehabil 24::42. ,2003. .
-
6.
Yeong, EK, HF Huang, YB Chen, et al. :The use of artificial dermis for reconstruction of full thickness scalp burn involving the calvaria. .Burns 32::375. ,2006. .
-
7.
Herlin, C, D Louhaem, M Bigorre, et al. :Use of Integra in a paediatric upper extremity degloving injury. .J Hand Surg Eur 32::179. ,2007. .
-
8.
Komorowska-Timek, E, A Gabriel, DC Bennett, et al. :Artificial dermis as an alternative for coverage of complex scalp defects following excision of malignant tumors. .Plast Reconstr Surg 115::1010. ,2005. .
-
9.
Gonyon Jr, DL and MR Zenn. :Simple approach to the radiated scalp wound using INTEGRA skin substitute. .Ann Plast Surg 50::315. ,2003. .
-
10.
Barnett, TM and JS Shilt. :Use of vacuum-assisted closure and a dermal regeneration template as an alternative to flap reconstruction in pediatric grade IIIB open lower-extremity injuries. .Am J Orthop (Belle Mead NJ) 38::301. ,2009. .
-
11.
Violas, P, A Abid, P Darodes, et al. :Integra artificial skin in the management of severe tissue defects, including bone exposure, in injured children. .J Pediatr Orthop B 14::381. ,2005. .
-
12.
Muangman, P, LH Engrav, DM Heimbach, et al. :Complex wound management utilizing an artificial dermal matrix. .Ann Plast Surg 57::199. ,2006. .
-
13.
Jeng, JC, PE Fidler, JC Sokolich, et al. :Seven years’ experience with Integra as a reconstructive tool. .J Burn Care Res 28::120. ,2007. .
-
14.
Orgill, DP, FH Straus II, and RC Lee. :The use of collagen-GAG membranes in reconstructive surgery. .Ann N Y Acad Sci 888::233. ,1999. .
-
15.
Campitiello, E, A Della Corte, A Fattopace, et al. :The use of artificial dermis in the treatment of chronic and acute wounds: regeneration of dermis and wound healing. .Acta Biomed 76( suppl 1:):69. ,2005. .
-
16.
Clayman, MA, SM Clayman, and DW Mozingo. :The use of collagen-glycosaminoglycan copolymer (Integra) for the repair of hypertrophic scars and keloids. .J Burn Care Res 27::404. ,2006. .
-
17.
Ahmed, S, SS Hussein, B Philp, et al. :Use of biologic dressing as a temporary wound dressing in reconstruction of a significant forehead Mohs defect. .Dermatol Surg 32::765. ,2006. .
-
18.
American Diabetes Association :Economic costs of diabetes in the U.S. in 2007. .Diabetes Care 31::596. ,2008. .
-
19.
Matricali, GA, G Dereymaeker, E Muls, et al. :Economic aspects of diabetic foot care in a multidisciplinary setting: a review. .Diabetes Metab Res Rev 23::339. ,2007. .
-
20.
Gibbons, GW, EJ Marcaccio Jr, AM Burgess, et al. :Improved quality of diabetic foot care, 1984 vs 1990: reduced length of stay and costs, insufficient reimbursement. .Arch Surg 128::576. ,1993. .
-
21.
Harrington, C, MJ Zagari, J Corea, et al. :A cost analysis of diabetic lower-extremity ulcers. .Diabetes Care 23::1333. ,2000. .
-
22.
Driver, VR, M Fabbi, LA Lavery, et al. :The costs of diabetic foot: the economic case for the limb salvage team. .JAPMA 100::335. ,2010. .
-
23.
Driver, VR and M Yao. :Discussion: the economics of limb salvage in diabetes. .Plast Reconstr Surg 127( suppl 1:):296S. ,2011. .
-
24.
Davis, WA, PE Norman, DG Bruce, et al. :Predictors, consequences and costs of diabetes-related lower extremity amputation complicating type 2 diabetes: the Fremantle Diabetes Study. .Diabetologia 49::2634. ,2006. .
-
25.
Ortegon, MM, WK Redekop, and LW Niessen. :Cost-effectiveness of prevention and treatment of the diabetic foot: a Markov analysis. .Diabetes Care 27::901. ,2004. .
-
26.
Stockl, K, A Vanderplas, E Tafesse, et al. :Costs of lower-extremity ulcers among patients with diabetes. .Diabetes Care 27::2129. ,2004. .
-
27.
Carls, GS, TB Gibson, VR Driver, et al. :The economic value of specialized lower-extremity medical care by podiatric physicians in the treatment of diabetic foot ulcers. .JAPMA 101::93. ,2011. .
Ease of Use, Safety, and Efficacy of Integra Bilayer Wound Matrix in the Treatment of Diabetic Foot Ulcers in an Outpatient Clinical Setting
A Prospective Pilot Study
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Department of Biology, University of Rochester, Rochester, NY.
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Background:
Integra bilayer wound matrix (IBWM) is a bilayer skin replacement system composed of a dermal regeneration layer and a temporary epidermal layer. It is used to treat various types of deep, large wounds via an inpatient procedure in an operating room. We sought to determine ease of use and effectiveness of IBWM in an outpatient clinical setting when treating diabetic foot ulcers. In addition, no epidermal autografting was performed in conjunction with the IBWM after silicone release, as is common in the inpatient setting.
Methods:
This 12-week, single-arm, prospective pilot study was conducted in three outpatient clinics. Weekly evaluations included monitoring the wound for signs of infection during the 12-week follow-up phase.
Results:
Eleven patients with diabetic foot ulcers who met the inclusion and exclusion criteria were enrolled. One patient was discontinued from the study owing to noncompliance leading to a serious adverse event. Therefore, ten patients who received the study intervention were included in the per-protocol population reported herein. The mean patient age was 60.6 years, with an average 11-year history of diabetes mellitus. Each ulcer was located on the plantar aspect of the foot. No infection was reported during the study. Patients treated with IBWM showed progressive wound healing over time: the greatest mean wound reduction was approximately 95% in week 12. Seven of ten patients (70%) achieved complete wound closure by week 12. No recurrent ulcers were reported during follow-up.
Conclusions:
These results are consistent with the hypothesis that IBWM is easy to use, safe, and effective when used on diabetic foot ulcers in an outpatient clinical setting without the secondary procedure of autografting for closure. (J Am Podiatr Med Assoc 103(4): 274–280, 2013)
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