NCT06625385招募中不适用
A Post-market, Prospective, Multi-center, Single-arm Study Evaluating the Safety and Efficacy of the 3M™ V.A.C. Peel and Place Dressing Used in Conjunction With 3M™ V.A.C.® Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Incidence of (ADEs)
研究概览
简要总结
The purpose of this clinical study is to obtain post-market safety and efficacy data when the V.A.C.® Peel and Place dressing is used in conjunction with 3M™ V.A.C.® Therapy.
详细描述
This is a prospective, post-market, multi-center, single-arm study. A target of 90 enrolled Subjects with 1 enrolled study wound per Subject is planned for this study, including 60 open wounds (10 for each type of open wound) and 30 closed or covered wounds (10 for each type of closed/covered wound). The entire duration of the study is expected to last approximately 2 years. Individual Subject participation is expected to last up to 20 days, including a screening period lasting up to 5 days, the day of initial treatment, dressing change visits as clinically appropriate but no more than 7 days from dressing application, and an end-of-treatment (EOT)/end-of-study (EOS) visit between Day 7 and Day 14 after the initial dressing application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 22 years old at the time of consent.
- •Subject or legally authorized representative (LAR) is able to provide informed consent.
- •Subject has a wound deemed appropriate for treatment with a V.A.C.® Peel and Place dressing (used in conjunction with 3M™ V.A.C.® Therapy), according to the instructions for use for the dressing, including the following wound types:
- •an open wound: traumatic wound, dehisced surgical wound within 30 days of surgery, burn, venous ulcer, diabetic ulcer, or pressure ulcer Note: Prior to initial placement, the wound may be debrided, as clinically indicated
- •a closed or covered wound secured with sutures or staples: closed surgical incision, skin flap closure, or skin graft (recipient site)
- •Subject is willing and able to attend all study visits.
排除标准
- •Subject is pregnant or lactating prior to application of the initial dressing. *
- •*Women who have had surgical sterilization by a medically accepted method (ie, tubal ligation, hysterectomy, or oophorectomy) or are post-menopausal, defined as not having menstruation for > 12 months will not be required to undergo pregnancy testing.
- •Subject is participating in another interventional clinical study or was enrolled in a clinical trial within the last 30 days before screening.
- •Subject has been diagnosed with a malignancy in the wound.
- •Subject has untreated osteomyelitis or untreated cellulitis in the wound.
- •Subject has an untreated systemic infection.
- •Subject has active cellulitis in the peri-wound area.
- •Subject has a known allergy or hypersensitivity to study materials: dressing(s), and/or dressing components such as acrylic or silicone adhesives or polyurethane.
- •Subject has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures or would compromise assessment of endpoints (wound/peri-wound condition).
- •Subject has had radiation directly to the wound area.
- •Subject received hyperbaric oxygen therapy within 30 days before the initial application of a V.A.C.® Peel and Place dressing.
- •Subject has been diagnosed with a major vascular deficit limiting arterial inflow into the wound region, as determined by the investigator's interpretation of the subject's medical history.
- •In the case of a lower extremity wound, the Subject has one of the following:
- •an ankle brachial index < 0.8;
- •no palpable pulse; or
- •no discernable audio Doppler signal.
- •Individual wounds are to be excluded from the study if they meet any of the following criteria
- •Wound has necrotic tissue and/or eschar present. NOTE: After debridement of necrotic tissue and complete removal of eschar, the V.A.C.® Peel and Place dressings may be used.
- •Wound contains a non-enteric or unexplored fistula(s) in the wound bed.
- •Wound has tunneling.
- •Wound has undermining that is ≥ 2 cm in any direction from the wound edge.
- •Wound site has inadequate hemostasis, as determined by the investigator.
- •Wound has exposed vessels, anastomotic sites, organs, or nerves that cannot be protected prior to placement of the V.A.C.® Peel and Place Dressings.
- •Wound has a depth greater than 2 cm (for small dressings), 4 cm (for medium dressing size), or 6 cm (for the large dressing size).
- •The wound received, within 30 days before initiating V.A.C.® Therapy, treatment with any of the following:
- •any previous negative pressure wound therapy device.
- •growth factors.
- •bioengineered tissue products, eg, skin or dermal substitutes.
- •Wound was closed with tissue adhesive.
- •Wound has, in the opinion of the Investigator, any characteristic that would make it unsuitable for the study.
研究组 & 干预措施
3M™ V.A.C.® Peel and Place Dressing
Experimental
3M™ V.A.C.® Peel and Place Dressing used in conjunction with 3M™ V.A.C.® Therapy
干预措施: 3M™ V.A.C.® Peel and Place Dressing (Device)
结局指标
主要结局
Incidence of (ADEs)
时间窗: 14 days
The incidence of adverse device effects (ADEs)
次要结局
- Percentage of closed surgical incisions and skin flaps that remain closed(14 days)
- Percentage of skin grafts with ≥ 90% graft take(14 days)
- Overall rate of wound healing for both open wounds and closed/covered wounds(14 days)
- Percentage of open wounds with evidence of healing(14 days)
研究者
研究点 (6)
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