Saturday, October 24, 2009 - 1:25 PM
16481

Use of Integra, a Bilayered Human Skin Equivalent, in the Treatment of Diabetic Foot Ulcers

Matthew L. Iorio, MD, Jesse Goldstein, MD, Melissa Adams, DPM, John Steinberg, DPM, and Christopher E. Attinger, MD.

Background

As the prevalence of diabetes mellitus rises and the age of onset decreases, the incidence of surgical complications such as peripheral vascular disease and diabetic foot ulcers (DFUs) is also projected to increase leading to higher amputation rates and rising costs.  The diabetic foot ulcer, although highly preventable with medical optimization and foot care, presents a therapeutic challenge to plastic surgeons and wound care specialists, especially when underlying tendon or bone is exposed.  Adequate debridement and stable coverage of these structures is paramount to preserving limb length and function. However, a paucity of local tissue for reconstruction, and poor skin graft take over these structures have led to the development of bioengineered substitutes which have met with moderate success.  Initially developed for burn and trauma patients, the dermal matrix template IntegraŽ allows for the ingrowth of granulation tissue and improved vascularity over bone and tendon.  This ingrowth potentiates viable skin grafting over bone and tendon and may preserve functional limb length in patients with DFUs.  This article reviews our use with the dermal matrix template IntegraŽ for the reconstruction of DFUs and post surgical defects.

Methods

A retrospective review was performed of all patients that underwent application of Integra by the senior authors (JSS, CEA) for lower extremity salvage between January 2004 and December 2008.  Patients were excluded if non-diabetic causes of ulceration including venous stasis disease and arterial insufficiency were present.  Clinic charts and operative notes were reviewed for demographic, surgical, and outcomes data including number of procedures, level of final amputation, and complications.

Results

Sixty-one patients with 67 separate wounds were analyzed during the study period.  Patients ranged in age from 22 to 80 (mean 58) years old and the average wound size was 25.9 cm2.  Twenty-one (31.3 %) wounds had exposed bone, 13 wounds (19.4 %) had exposed tendon, and 1 (1.5 %) had exposed hardware.  Average follow up was 325 days, and average number of operations until closure was 1.28.  A total of 18 amputations (29.5%) occurred despite IntegraŽ application with 15 major and 3 minor amputations.  Thirty wounds went on to complete healing, and the remainder decreased in size by over 40% (p < 0.03).  Of those that healed or decreased in size, 10 wounds had exposed bone and 13 wounds had exposed tendon. There was no difference in patient age or comorbid conditions between patients who needed amputations and those that went on to heal (p = 0.5).

Conclusions

The use of IntegraŽ for the treatment of complex diabetic foot ulcers with exposed bone or tendon is beneficial in preserving functional limb length and preventing higher amputation.

Image 1

A 43 year-old male diabetic presented with gas gangrene of the left foot.  After repeat debridements, exposed tendon and bone were covered with IntegraŽ (left panels).  At 6 months, the defect remains well healed and stable (right panels).