Prospective Randomized Controlled Trial Comparing Infection Rates and Wound Closure Following Transmetatarsal Amputation With Aid of Electrospun Fiber Matrix
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Infection rate of transmetatarsal amputation site at 1 week postoperative
研究概览
简要总结
Transmetatarsal amputation (TMA) patient populations commonly have poor healing outcomes and a large number of complications. There has been little study on the benefits of augmenting a TMA with a synthetic graft substitute. The long term goal is to push for an application of synthetic graft substitute to reduce infection rates and aid in the healing process. Augmenting a TMA with a synthetic electrospun fiber matrix will demonstrate utilization of the product and other comparators in generating wound healing and infection rate outcomes including rate of infection, wound dehiscence and total healing response. Electrospun fiber matrices have long been investigated as an innovative construct for use in tissue engineering and regenerative medicine research due to their ability to mimic the structure and scale of native tissue. Clinical studies have demonstrated clinical efficacy in treating both chronic and acute wounds. There is strong evidence to support the application of a synthetic electrospun fiber matrix will generate favorable wound healing and reduce infection rates.
详细描述
Intervention or Exposure
- Transmetatarsal amputation with application of synthetic electrospun fiber matrix
- After surgery, patient will be off-loaded to the surgical site with an off-loading device based on the investigator's decision, e.g., a boot for forefoot and a heel protector for hindfoot. Patients should be instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean.
Comparison intervention or Exposure
- Transmetatarsal amputation without application of synthetic electrospun fiber matrix
- After surgery, patient will be off-loaded to the surgical site with an off-loading device based on the investigator's decision, e.g., a boot for forefoot and a heel protector for hindfoot. Patients will be instructed on how to care for the surgical site, utilize an off-loading device, and keep the surgical site moist and clean.
Outcomes
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
- 是
入选标准
- •Undergoing TMA
- •At least 18 years old
- •Adequate perfusion demonstrated by either TcPO2 or ankle-brachial index (ABI) or toe-brachia index (TBI) within 60 days prior to enrollment/randomization (Dorsum TcPO2 of study leg(s) ≥40mmHg OR ABI of study leg(s) with results of ≥ 0.7 and ≤ 1.3 OR TBI of study extremity(ies) with results of ≥ 0.5).
- •Patient is willing and capable of complying with all protocol requirements.
- •Patient or legally authorized representative (LAR) is willing to provide written informed consent prior to any study procedures
排除标准
- •Previously enrolled into this study or is currently participating in another prospective drug or device study that has not reached its primary endpoint.
- •Patient is pregnant, breast feeding or planning to become pregnant.
- •Patient has a known allergy to resorbable suture materials.
- •Patient has a life expectancy less than three months as assessed by the investigator.
- •Patient has received skin substitutes during the run-in period or within 14 days prior to beginning of run-in period.
- •Patient currently undergoing cancer treatment.
- •Patient diagnosed with autoimmune connective tissue.
- •Patient is taking parenteral corticosteroids or any cytotoxic agents for 7 consecutive days during the run-in period or up to 30 days before the run-in period.
- •Chronic oral steroid use is not excluded if dose is <10 mg per day for prednisone.
- •Patient unwilling or unable to safely utilize appropriate offloading device to unweight wound(s).
研究组 & 干预措施
Transmetatarsal amputation with primary closure
Transmetatarsal amputation with primary closure and no application of synthetic electrospun fiber matrix.
Transmetatarsal amputation with application of synthetic electrospun fiber matrix
Transmetatarsal amputation with application of synthetic electrospun fiber matrix
干预措施: Synthetic electrospun fiber matrix (Device)
结局指标
主要结局
Infection rate of transmetatarsal amputation site at 1 week postoperative
时间窗: 1 week post-operatively
Assessment for signs of infection to transmetatarsal amputation site in both groups at 1 week post-operative follow-up visit. * Assess if patient currently on antibiotics * Amount of wound exudate (none, scant, small, moderate or large) * Type of wound exudate (bloody, serosanguinous, serous, purulent, or foul purulent) * Erythema, edema, and/or increased warmth at surgical site * Presence of fevers or chills * Clinical signs of infection * Photographs taken of the surgical site to document appearance * Wounds measured in centimeters (length, width, depth)
次要结局
- Wound healing status of transmetatarsal amputation site at 12 weeks postoperative(12 weeks postoperatively)
- Infection rate of transmetatarsal amputation site at 2, 4 and 12 weeks postoperative(2, 4 and 12 weeks postoperatively)
- Wound dehiscence rate of transmetatarsal amputation site at 12 weeks postoperative(12 weeks postoperatively)
研究者
Trent Brookshier
Principal Investigator
Scripps Health