NCT01867580已完成不适用
A Prospective, Randomized, Multi-Center Trial Evaluating the Effectiveness of the V.A.C. Ulta Negative Pressure Wound Therapy System With V.A.C. VeraFlo Dressing System in Operatively Debrided Wounds
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KCI USA, Inc
- 入组人数
- 181
- 试验地点
- 14
- 主要终点
- Number of Inpatient Operating Room Debridements
研究概览
简要总结
The purpose of this study is to examine the effectiveness of the Veraflo with Prontosan vs VAC in wounds that require operative debridement.
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 Subject:
- •has a wound prior to informed consent
- •will be admitted as an inpatient
- •is >= 18 years of age at time of consent
- •is able to provide his/her own informed consent
- •is willing and able to return for all scheduled and required study visits
- •has an open wound >= 4cm in any plane of measurement excluding tunnels after initial surgical debridement
- •has a wound that is appropriate for NPWT according to approved indications for use
- •has not participated in a clinical trial within the past 30 days
- •has a 30 day wound history available if the wound has been previously treated
排除标准
- •The Subject:
- •is pregnant as determined by a positive serum or urine pregnancy test at the time of screening
- •has a life expectancy of < 12 months
- •is not healthy enough to undergo surgery for any reason
- •has, in the investigator's opinion, any clinically significant condition that would impair the participant's ability to comply with the study procedures
- •has, in the opinion of the investigator, a condition that will not allow the subject to tolerate the therapy (e.g. painful conditions such as vasculitis)
- •has rheumatoid arthritis
- •has a bleeding disorder or coagulopathy
- •has a wound that contains antibiotic cement or beads
- •has an ischemic lower extremity wound as determined by lack of detectable pulses in the extremity or ankle-brachial pressure indices of < 0.9 with a history of diabetes, or < 0.6 if the subject is non-diabetic
- •has a known allergy or hypersensitivity to V.A.C. Therapy dressing components including polyurethane or polyvinyl alcohol (drape and foam), or materials that contain acrylic adhesive (drape adhesive)
- •has a known allergy or hyper sensitivity to 3M Cavilon No Sting Barrier Film or any of its components including Hexamethyldisiloxane, isooctane, acrylate terpolymer, polyphenylmethysiloxane, copolymer
- •has a know allergy or hypersensitivity to Prontosan or any of its components including polyhexamethylene biguanide (PHMB), or undecylenamidopropyl betaine
- •has received NPWT on the study wound within the last 30 days
- •has a wound that is contraindicated with Prontosan
- •a. presence of hyaline cartilage in the wound
- •has a wound that is contraindicated with V.A.C. Therapy including:
- •malignancy in the wound
- •untreated osteomyelitis
- •non-enteric or unexplored fistulas
- •necrotic tissue with eschar remaining in the wound after debridement (NOTE: Once necrotic tissue or eschar is removed from the wound bed, subjects may be included)
- •unprotected, exposed blood vessels, anastomotic sites, organs, or nerves in direct contact with foam
- •use of intervening layers between the wound bed and foam
- •has a wound that is contraindicated with V.A.C. VeraFlo Therapy including:
- •Thoracic or abdominal cavities
- •Unexplored wounds that may communicate with adjacent body cavities
- •has a wound that is closed after the initial debridement
结局指标
主要结局
Number of Inpatient Operating Room Debridements
时间窗: until the wound is deemed ready for closure or coverage by the investigator up to 64 days
Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room
次要结局
- The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis.(Immediately following initial post debridement to the first dressing change up to 72 hours)
研究者
研究点 (14)
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