Diabetic Foot Ulcer Clinical Trial
Official title:
The Study of Wound Dressings for Portable Negative Pressure Wound Therapy
Introduction Negative pressure wound therapy (NPWT), also known as topical negative
pressure, has become a popular therapy for the treatment of many acute and chronic wounds.
In many randomized controlled trials(RCTs), NPWT also has benefit in diabetic foot ulcer and
pressure ulcer. However, most studies used commercial VAC device in combined with
polyurethane (PU) foam. It is not yet clear where NPWT combined with gauze as wound filler
is as effective as the PU foam. This RCT evaluated the efficacy of the gauze and PU foam,
two kinds of fillers routinely used in negative pressure wound therapy, on the healing of
the diabetic lower-extremity ulcers and the pressure ulcer.
Methods From 2010/1 to 2015/01, the in-patient persons with difficult to heal diabetic ulcer
or Grade 4 pressure ulcer were enrolled. These patients were divided into two groups
randomly. The letter of consent was signed by the patient or patient's family. After
debridement of the infective wound, the wound of experimental group was packed with a
moistened Polyhexamethylene biguamide (PHMB) impregnated gauze (Kerlix AMD, Covidien). A
noncollapsible drainage tube (Blake drain, Ethicon) was applied to the wound, and then
sealed with 3M Tegaderm Film. The system was connected to a 1-bottle water-seal chest
drainage system and to standard wall suction at 125 mmHg negative pressure. The dressing was
changed at 72- to 96-hour intervals (twice a week) for a period of 3 weeks. To the control
group, the PU foam dressing from KCI was packed and sealed to the wound with the same
continuous wall suction at -125mmHg. Investigators observed and recorded the ulcer area
twice a week on each time of changing dressing in the following 3 weeks. The percentage of
wound area reduction(PWAR) was used as a predictor of wound healing. The repeated measuring
data were analyzed using linear mixed mode with SPSS statistical software. This clinical
study was approved and monitored by Institutional Review Board of Show Chwan Memorial
Hospital.
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