Curación asistida por presión negativa comparada con curación convencional en el tratamiento del pie diabético amputado. Ensayo clínico aleatorio

Abstract

Introduction Foot amputation wounds in patients with diabetes are complex and treatment is often difficult. At the moment negative pressure wound therapy (NPWT) is widely used for the treatment of several types of wounds. Nevertheless, the clinical evidence to support the application of this dressing in foot amputation wounds in patients with diabetes is scarce. The aim of this study was to evaluate the efficacy of NPWT compared with standard wound dressing to treat diabetic foot amputation wounds. Patients and method Randomised controlled trial. Diabetic patients aged 18 years or older with a foot amputation wound were assigned to treatment with NPWT (A group) or standard wound dressing (B group). Primary efficacy end point was time in reaching 90% of wound granulation. A size of sample of 11 patients per group was used. NPWT was prepared with a polyurethane ether foam dressing, a Nelaton catheter, a transparent adhesive drape and continuous negative pressure of 100 mmHg. The wound was treated every 48–72 h and evaluated weekly. Descriptive and analytical statistics were used. Results There were 24 patients, with a mean age of 61.8±9 years (79% men), 12 in each group. The average time to reach 90% of granulation was lower in A group (18.8±6 days versus 32.3±13.7 days), a statistically significant difference ( P=0.007). Conclusion NPWT reduces the granulation time of diabetic foot amputation wounds by 40%, compared with the standard wound dressing.