A Prospective, Open, Comparative, Randomized Single-center Study to Evaluate the Effect of V.A.C. VeraFlo™ Therapy With .125% Dakins vs V.A.C. Ulta™ Therapy on Biofilm Removal/Disruption/Elimination in Chronically Infected Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers
研究概览
简要总结
This study would like to determine if using negative pressure wound therapy with an instillation of .125% Dakins is more effective than using negative pressure wound therapy alone on biofilm removal, disruption and elimination in chronically infected lower extremity wounds.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is of 18 years or older.
- •Males and females - provided they are not pregnant and if of reproductive age are using contraception.
- •Patient with ulcers that:
- •Have an ulcer area of at least 4 cm2 confirmed via counting squares on an wound tracing
- •Have been present for at least 4 weeks
- •Are confirmed to have a colony forming unit per gram of wound tissue greater than or equal to 10 to the 5th cfu
- •Are full thicknesses through to dermal or subcutaneous tissue but not extending to muscle or bone.
- •The patient has an ABI of greater or equal to 0.8 and lower than 1.3 or has a suitable Peripheral Vascular Resistance (PVR) and Doppler assessment which confirms venous disease & therefore treatment with Profore is deemed acceptable by the clinician.
- •The patient has one or more clinical signs of infection (edema, malodor, local/periwound erythema, spontaneous pain between dressing changes, increased exudate, discoloration of granulation tissue, increased temperature at wound, non progression of wound, purulent exudate and friable granulation tissue)
- •The patient is able to understand the evaluation and is willing to consent to the evaluation.
- •Patients with a suitable wound on a different limb to any other wounds previously eligible.
排除标准
- •Patients undergoing chemotherapy
- •Patients being treated with immunosuppressive drugs or corticosteroids
- •Patients with an autoimmune disease
- •Patients who have participated in an experimental drug or device study within the last 15 days
- •Patients that have been entered in this evaluation previously as an evaluable patient.
研究组 & 干预措施
VAC VeraFlo with Dakins Instillation
VAC VeraFlo with Dakins .125% instillation will be initially applied in the OR after surgical debridement. Dressing will be changed on day 4 and and removed on day 7. Wound assessments will continue at weeks 2, 3, and 4.
干预措施: VAC VeraFlo with Dakins Instillation (Device)
VAC Ulta Therapy
VAC ULTA Therapy will be initially applied in the OR after surgical debridement. Dressing will be changed on day 4 and and removed on day 7. Wound assessments will continue at weeks 2, 3, and 4.
干预措施: VAC Ulta Therapy (Device)
结局指标
主要结局
Change in Bacteria Colony-forming Units Using When NPWT and NPWTi on Venous Leg Ulcers
时间窗: Baseline and day 7
Biopsies for bacteria colony-forming units obtained at pre surgical debridement (baseline) and day 7.
次要结局
未报告次要终点