A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of days between the application of the dermal substitute to when the dermal substitute is deemed suitable for grafting by the treatment care team.
研究概览
简要总结
This is a prospective, randomized, controlled, multi-center clinical study comparing SupraSDRM® to standard of care wound dressing, BTM, in the treatment of full-thickness wounds deemed not immediately suitable for definitive grafting will be performed.
详细描述
Twenty-four patients with full-thickness wounds fulfilling inclusion criteria of the study will be consented and enrolled into the clinical trial. An area (≥ 5 and ≤125 cm2) deemed not immediately ready to accept skin graft will be designated as the study site. The study site will be randomized to receive either SupraSDRM® or the SoC wound dressing, NovoSorb® BTM.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age ≥18 years and ≤85 years
- •Full-thickness traumatic injury, surgical wound, or excised full-thickness burn (e.g., friction, contact, flame, scalding etiology), where immediate grafting is not deemed suitable by the treating surgeon
- •Wound size ≥ 5cm2 not immediately suitable for graft application
- •Subject or legally authorized representative is able and willing to sign informed consent
排除标准
- •Study wound may not include areas of the face, and neck and genitalia.
- •Wound with metal hardware exposure
- •Pressure sores
- •Wounds with residual malignancy
- •Wound infection at the time of planned wound dressing application
- •Wound that is a part of an active treatment arm of an interventional study (within 90 days of Screening Visit)
- •Pregnancy/lactation
- •Subjects who are unable to follow the protocol or who are likely to be non-compliant
- •Subjects with uncontrolled diabetes (defined by Hgb A1C >10)
- •Subjects who are receiving systemic steroids or immune suppressive treatment
- •Subject with a known allergy to polylactide, polycaprolactone, polyvinyl alcohol, trimethylene carbonate or resorbable suture materials.
- •Prisoners
研究组 & 干预措施
SupraSDRM®
Once randomization is completed and the site is adequately debrided the assigned treatment dressing will be applied according to their respective instructions for use. Supplemental supportive dressings including negative pressure treatment may be used in conjunction with the study dressings.
干预措施: SupraSDRM® (Device)
SOC Skin Substitute
Once randomization is completed and the site is adequately debrided the assigned treatment dressing will be applied according to their respective instructions for use. Supplemental supportive dressings including negative pressure treatment may be used in conjunction with the study dressings.
干预措施: NovoSorb® BTM (Device)
结局指标
主要结局
Number of days between the application of the dermal substitute to when the dermal substitute is deemed suitable for grafting by the treatment care team.
时间窗: up to 5 weeks
This endpoint is based on the ability of the dermal substitute to rapidly vascularize and allow for placement of a skin graft.
次要结局
- Days of skin graft application from time of SupraSDRM® or SoC application(up to 5 weeks)
- Skin graft contraction(up to 1 year)
- Percentage graft survival as assessed 7 days after skin graft application(7 days)
- Wound Pain scale 1-10(up to 1 year)
- Clinical incidence of skin substitute infection(up to 5 weeks)
- Number of return trips to the OR(up to 1 year)
- Cost-effectiveness(up to 1 year)