Prospective, Multi-center, Randomized, Open Label, Parallel Group Controlled, Non-inferiority Trial Evaluating the Efficacy and Safety of the VERAFLO™ Dressing Kit for Wound Bed Preparation in Open Wounds With Extensive Soft Tissue Damage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KCI USA, Inc
- 入组人数
- 170
- 试验地点
- 4
- 主要终点
- Wound Volume Reduction Rate (Unit: %)
研究概览
简要总结
The objectives are to evaluate the efficacy and safety of the V.A.C. VERAFLO™ Dressing Kit for wound bed preparation in open wounds with extensive soft tissue damage in this trial.
详细描述
The management of wounds represents a significant challenge in healthcare. There are many considerations necessary in developing the optimal treatment plan for achieving wound care goals. Current standard wound treatment in the management of wounds may involve clinical assessment, debridement, antibiotic treatment and local application of antiseptics or antimicrobials, and drainage.
The choice of therapeutic modality is one of many important decisions. Over time, wound care has progressed from the use of products such as dry gauze to advanced moist wound therapies and further to active wound healing therapies. One of such advanced wound healing therapies is negative pressure wound therapy (NPWT), which was developed in the 1990s. NPWT is a technology that is currently widely used in wound care and is promoted for use on complex wounds (open wounds). The therapy of NPWT and solution instillation with a dwell time (NPWTi-d) is used to adjunctively treat high-risk wounds that would benefit from vacuum-assisted drainage and controlled repeated delivery of topical wound solutions, such as normal saline and wound cleansers. Evidences suggests that normal saline is effective and readily available.
V.A.C. VERAFLO™ Dressing Kit, which was the investigational device, was a reticulated open-cell foam polyurethane ester dressing that could deliver normal saline instillation solution to the wound site for NPWTi-d therapy. The V.A.C. VERALFO™ Dressing Kit was approved in July 2010 by the U.S Food and Drug Administration (U.S. FDA) and December 2022 by the China National Medical Products Administration (NMPA).
This trial was designed as a pre-marketing trial of the V.A.C. VERAFLO™ Dressing Kit in China for NMPA registration. The device V.A.C. VERALFO™ Dressing Kit did not get NMPA approval when the study was initiated. On December 20th, 2022, it was approved by NMPA (Registration No.: 国械注进 20223140619).
There were no approved NPWTi-d dressings in China market during protocol design, so a negative pressure wound drainage material manufactured by Guangdong Shuangling Pharmaceutical Co., Ltd. was selected as the control group treatment device, which can apply the NPWT therapy with wall suction.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only adult subjects meeting all of the following criteria to be considered for participation:
- •Subject voluntarily participate in the trial and sign the informed consent form, and is willing to comply with protocol and all visits
- •Is anticipated to be an inpatient for a minimum of 6 days
- •Age: between 18 years and 70 years
- •Patient with open wounds from various etiologies with extensive soft tissue damage after definitive surgical debridement and appropriate for NPWT
- •The minimum size of the wound as measured by 3D wound imaging prior to entry into the study is 8cm (in any dimension), minimum 1cm in width and 0.8cm in depth. i.e. the minimum wound size is 8cm×1cm×0.8cm. Only one wound per subject will be included in the study, regardless of how many wounds the subject has.
- •Female subjects of reproductive potential must have a negative pregnancy test result and must not be lactating at the screening visit.
- •Subject must be willing and able to use a highly effective contraception method during study participation.
排除标准
- •Subject who meets any of the following criteria will be excluded from participation in the study:
- •Subject undergoing chemotherapy
- •Subject with known immunodeficiency
- •Subject with serious complications or serious systemic infection
- •Known bleeding disorder or has received or is planning to receive long-term anticoagulation therapy
- •Known allergic reactions/hypersensitivity to any of the study treatment dressings components
- •Target wound is a burn wound
- •A wound open for 6 months or more
- •The subject's targeted traumatic wound injury is a craniofacial wound
- •There is implant (such as cardiac pacemaker, bone nail, bone lamella, artificial joint, artificial bone) visible in the targeted wound.
- •If undermining or tunneling represents approximately 15% or more of the wound.
- •A wound with enteric fistulas.
- •Subject's targeted wound that is contraindicated with investigational device including:
- •Malignancy in the wound
- •Untreated osteomyelitis
- •Non-enteric or unexplored fistulas
- •Necrotic tissue with eschar remaining in the wound after surgical debridement (once necrotic tissue or eschar is removed from the wound bed, subjects may be included)
- •Unprotected, exposed blood vessel, anastomotic sites, organs, or nerves in direct contact with foam
- •Thoracic or abdominal cavities
- •Unexplored wounds that may communicate with adjacent body cavities
- •Subject's targeted wound that is contraindicated with the control group device and not suitable for participating in the trial judged by investigator
- •Participation in another device or drug study within the past 30 days before screening or during study participation
- •Other subjects who are not suitable for participating in the trial judged by investigator.
- •Wounds that require more than 2 images in order to capture the entire wound. NOTE: each image must not exceed 20 cm in any one direction.
- •Wound presents on greater than 50% of the circumference of any part of the body (e.g. wound that wraps around >50% of a leg or arm).
结局指标
主要结局
Wound Volume Reduction Rate (Unit: %)
时间窗: over 14 days or until deemed ready for closure by investigator (whichever occurred first)
percent of total wound volume change relative to baseline over 14 days or until deemed ready for closure by investigator (whichever occurred first) over 14 days or until deemed ready for closure by investigator (whichever occurred first)
次要结局
- Time to Completion of Wound Bed Preparation (Unit: Day)(Over 14 days or until deemed ready for closure by investigator (whichever occurred first))
- Wound Area Reduction Rate (Unit: %)(Over 14 days or until deemed ready for closure by investigator (whichever occurred first))