Outcomes and Predictors of Wound Healing among Patients with Complex Diabetic Foot Wounds Treated with a Dermal Regeneration Template (Integra) 

SLR - December 2020 - Alex L. Barnett

Reference: Hicks CW, Zhang GQ, Canner JK, Mathioudakis N, Coon D, Sherman RL, Abularrage CJ. Outcomes and Predictors of Wound Healing among Patients with Complex Diabetic Foot Wounds Treated with a Dermal Regeneration Template (Integra). Plast Reconstr Surg. 2020 Oct;146(4):893-902. doi: 10.1097/PRS.0000000000007166. PMID: 32639434.

Level of Evidence: Level IV

Scientific Literature Review 

Reviewed By: Alex L. Barnett, DPM
Residency Program: John Peter Smith Hospital – Fort Worth, TX

Podiatric Relevance: A majority of patients that require debridement for soft tissue infection are left with wounds that are unable to be closed by primary intention. Augmentation with graft is primarily used to help close these wounds. A dermal regeneration template is commonly used to help fill the defect and helps prevent future infections which could lead to more amputations.

Methods: The authors included all patients who underwent debridement of diabetic foot ulcers or gangrene that was treated with a dermal regeneration template with the time frame being March 2013 to February of 2019 by the Johns Hopkins Limb Preservation Team. WIfI wound classification was used to classify the wounds. The primary outcomes of the study were dermal regeneration/incorporation and complete wound healing. Wound healing rates were reported with Kaplan- Meier analyses. Cox univariable and multivariable proportional hazard ratios were used for characteristics of wound healing.

Results: Eighty-five patients were treated during the study period with 107 complex wounds. Mean age was 61, mean Hgb A1C was 8.94 percent, most associated comorbidities were loss of peripheral sensation, hypertension, peripheral arterial disease, hyperlipidemia. Mean wound area was 30.9 centimeters and depth was 1.24 centimeters. In terms of location, 45.8 percent of wounds were on the forefoot, 23.4 percent on the heel, 19.6 percent on the midfoot, 5.6 percent on the ankle and Achilles tendon. Osteomyelitis was found in 76 of the patients. The majority of wounds were WIfI stage 4 wounds at 66.4 percent. Most patients received negative pressure therapy at 82.2 percent, while the rest of the patients received a bolster dressing. The overall success rate of integration of the dermal regeneration template was 66.7 percent. Only 81.3 percent of the wounds received one application of the template, 15.9 percent received two applications, and 2.8 percent received three. Mean time to complete wound healing was 198 days. Kaplan-Meier analysis estimated 12-month and 18-month wound healing rates were 79 percent and 93 percent, respectively. Wound characteristics that were significant for wound healing were found to be  forefoot ulcerations and those with bone involvement.

Conclusions: The authors concluded that application of the dermal regeneration template resulted in adequate wound healing and excellent limb salvage outcomes. They demonstrated that proper application of the dermal regeneration template with negative pressure therapy or bolster dressings gave the diabetic foot the best chance to heal with reducing the chances for future amputations. Proper postoperative management is also essential to help ensure favorable wound healing chances. Overall, this study shows how important these templates are to patient’s population in returning to base line quality of life and as an adjunct for wound healing.