A Single Arm, Prospective Clinical Trial Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KCI USA, Inc
- 入组人数
- 33
- 试验地点
- 6
- 主要终点
- Ease of Use Assessment
研究概览
简要总结
The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.
详细描述
The objective of this study is to evaluate the ease of use of the V.A.C® GranuFoam™ Bridge dressing on Diabetic Foot Ulcers under ActiV.A.C® negative pressure wound therapy for a period of 48-72 hrs (+6hrs). Ease of use will be determined based on the feedback on the following characteristics 1) Ease of dressing application 2) Ease of dressing removal and 3) Ease of dressing conformability. Additionally patient feedback on comfort during wear will also be collected. Patients currently prescribed to V.A.C.® Therapy will be enrolled in the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Male or Female subjects must be ≥ 18 years of age
- •Subject is willing and able to provide written informed consent and comply with protocol required procedures
- •Subject has a calcaneal, dorsal or plantar diabetic foot ulcer no greater than a Grade 2 on the Wagner Grading System for which ActiV.A.C.® Therapy has been prescribed and requires off loading of the SensaT.R.A.C. PadTM
- •Subject has a foot ulcer that is ≥ 1.5cm2 but no greater than 84 cm2
- •Female subject that is willing to use an effective method of contraception for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least twelve (12) months prior to enrollment. Acceptable means of contraception is defined as use of Birth control pills, Depo Provera® , Norplant® , IUD (intrauterine device), Diaphragm with spermicide, Condom with spermicide
排除标准
- •Subject's wound measures > 84 cm2
- •Presence of untreated cellulitis
- •Presence of untreated or refractory osteomyelitis (including untreated necrotic bone, non-viable tissue and infected bone)
- •History of radiation to the wound area
- •History of thermal injury in the wound area
- •Known hypersensitivity to any disposable component of the V.A.C.® Therapy system
- •Necrotic tissue with eschar present that cannot be debrided prior to subject enrollment in the study
- •Subject is exhibiting active signs and symptoms of infection of the wound(i.e. increased redness or erythema, increased pain, warmth, purulent drainage)
- •Past or current enrollment in this clinical study or any other clinical study within 30 days
- •Female Subject who is pregnant or is unwilling to use acceptable means of contraception during the duration of her participation in the study
- •Subject exhibits significant peri-wound issues that in the opinion of the investigator can interfere with the study assessments
- •Subject is unable to co-operate with study assessments or has a history of non-compliance with off-loading modalities or has a foot deformity that in the opinion of the investigator does not allow for appropriate dressing application or off loading placement.
研究组 & 干预措施
VAC GranuFoam Bridge Dressing
This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours.
干预措施: V.A.C. Negative Pressure Wound Therapy System (Device)
结局指标
主要结局
Ease of Use Assessment
时间窗: 48-72 hours (+6 hours) time period
Each subject was assessed on the three scales (each scale was 1-Poor, 2 - Fair, 3 - Good, 4 - Excellent) and given a score on each individual characteristic (Ease of Dressing Application, Ease of Conformability, and Ease of Dressing Removal). The scores were then summed for each subject with possible range being 3-12. If the subject had a total score greater than or equal to 6, and a minimum score of greater than or equal to 2 on each individual characteristic then the subject was included in the percentage of subjects with satisfactory performance. Note that for each scale higher scores indicate better outcomes.
次要结局
未报告次要终点