A Prospective, Single-arm, Clinical Trial of Electrospun Fiber Matrix (Restrata) in the Treatment of Surgical Defects Secondary to Resection of Malignant Cutaneous Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Time to wound bed granulation
研究概览
简要总结
The goal of this observational prospective study is to evaluate wound healing outcomes in resection wounds resulting from surgical removal of cutaneous malignancies treated with a synthetic electrospun fiber matrix. This study intends to quantify the time from initial resection and product application to time of complete granulation of the wound bed in weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient is at least 18 years old
- •Patient plans to undergo surgical resection of a cutaneous neoplasm
- •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 participation in study
- •Post-resection surgical wound with a surface area of ≥4 cm2 and ≤ 36cm2
排除标准
- •Inability to give informed consent or to complete the procedures required for study completion
- •Patient has been previously enrolled into this study, or is currently participating in another 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, e.g. Polyglactin 910 (PGLA), Polydioxanone (PDS)
- •Patients receiving any immunotherapy, radiation, or chemotherapy within the past four weeks prior to resection surgery.
- •Patient has a life expectancy less than six months as assessed by the investigator
- •Patient has an additional non-study related wound within 3 cm of the study wound
- •Study wound is located on the hands or feet
- •Patient has been diagnosed with osteomalacia
- •Resection defect from a squamous cell carcinoma arising from a chronic wound
- •Patient has an uncontrolled thyroid disorder
- •Hgb A1c > 12% within 3 months prior to enrollment in patients with a known history of diabetes
- •Patient has a BMI > 34.9
- •Patient has used any tobacco product within the past 30 days prior to surgery
- •Patients with chronic kidney disease on peritoneal or hemodialysis, or with an estimated glomerular filtration rate less than 15mL/min
- •Patients with severe liver disease with active cirrhosis defined as a gross ascites upon clinical exam or a Model for End-stage Liver Disease (MELD)-Na score greater than 15
- •Patient not in reasonable metabolic control in the judgement of the investigator
- •Patient has a known history of poor compliance with medical treatment
- •Patient has a history of radiotherapy to wound bed of interest
- •Patient has been diagnosed with at least one of the following autoimmune connective tissue diseases: lupus, vasculitis, sickle cell, or uncontrolled rheumatoid arthritis
- •Active infection, undrained abscess, or critical colonization of the wound with bacteria in the judgement of the investigator
结局指标
主要结局
Time to wound bed granulation
时间窗: Weekly assessments until granulation achieved or up to 6 weeks following resection surgery
Time from initial resection and product placement to the time of at least 75% wound bed granulation using a modified Bates-Jenson Scale. The Bates-Jenson Scale for Granulation Tissue ranges from: 1=Skin intact or partial thickness wound, to: 5=No granulation tissue present. Wounds are considered "granulated" upon receiving a rating of 2 (Bright, beefy red;75% to 100% of wound filled \&/or tissue overgrowth) or less upon investigator assessment. Lower scores are indicative of better outcomes.
次要结局
- Time to skin grafting(Weekly for up to 6 weeks post-resection)
- Tissue flap take rate(1 week after tissue flap procedure)
- Time to complete wound healing(Until healed or until 16 weeks post resection)
- Skin graft "take" rate(1 week after skin graft application)
- Patient pain(Weekly for up to six weeks post resection)