A Single-Blind, Randomized, Controlled, Single Center Clinical Study to Assess the Safety and Efficacy of DERMASEAL Advanced Wound Care Dressing for the Treatment of Split-Thickness Skin Graft Donor Site Wounds
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 主要终点
- wound pain
研究概览
简要总结
The goal of this study to determine whether the combination biologic/drug DERMASEAL will safely decrease donor wound pain after split-thickness skin graft surgery. Participants will have their skin graft donor sites immediately treated with DERMASEAL versus standard of care wound dressings followed by periodic monitoring of their recovery.
详细描述
This is a single center, single-blind, randomized, controlled phase 1/2 study of patients undergoing treatment of a cutaneous wound involving a split-thickness skin graft. A subject's study duration will be for up to a total of 16 weeks from randomization to end of study. This includes 1 week of treatment, followed by 3 weeks of Standard of Care plus a final follow-up visit 12 weeks after complete wound closure or the end of Standard of Care.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Outcomes Assessors will evaluate pain and scarring using the Visual Analog Scale (VAS) Vancouver Scar Scale (VSS) without knowledge of the participants' treatment group assignment.
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women ≥ 21 years of age.
- •The subject is able and willing to adhere to study procedures and informed consent is obtained.
- •Patient scheduled to undergo a split-thickness skin graft > 25 cm2 and ≤ 300 cm2 with a wound depth of between 0.010 - 0.015 inch (0.2 - 0.4 mm).
- •Target donor site wound involving the torso or upper or lower extremities.
- •Patient has a palpable pulse at the wrist or ankle indicating adequate arterial perfusion of the extremity from which the skin graft is harvested.
- •Serum creatinine <2.0 mg/dl within the last 6 months.
- •Negative urine pregnancy test at screening for women of childbearing potential. i) Women participants are considered of non-childbearing potential if they are pre-menopausal with a documented hysterectomy or bilateral oophorectomy; or post-menopausal defined as the cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; or have a serum FSH level confirming the post-menopausal state.
排除标准
- •Hypersensitivity to silver or fresh frozen plasma.
- •Active infection or history of radiation to the donor site.
- •Insensate at the donor site.
- •Elevated INR>3.
- •The subject was previously entered into this study or had participated in any study drug or medical device study within 30 days of screening.
- •Currently on a treatment regimen or medications which in the opinion of the investigator are known to interfere with wound healing (for example: cancer chemotherapy or equivalent immunosuppressants, systemic steroids > 10 days of treatment, cytostatic drugs, COX-2 inhibitors, or radiation therapy).
- •Excessive lymphedema that in the opinion of the investigator will interfere with wound healing.
- •A cognitive, physical, or psychological condition interfering with subject's ability to comply with the treatment regimen.
- •Subject is on dialysis.
- •Patients who are pregnant, breast feeding, or unwilling to practice contraceptive methods during participation in the study, if applicable. Effective methods of contraception include:
- •i. oral, injectable, or implanted hormonal contraceptives ii. intrauterine device or system, iii. barrier method with spermicide, or iv. bilateral tubal occlusion.
- •Patients with uncontrolled anemia (Hgb<10 g/dL in women; <12 g/dL in men) at Screening.
- •Severe malnutrition (serum albumin ≤2.0 with a normal CRP).
结局指标
主要结局
wound pain
时间窗: 16 weeks
The study will evaluate if using DERMASEAL is associated with a clinically meaningful difference in pain score (≥2 points on the Visual Analog Scale; minimal score =0 and maximal score = 10. A higher score means more pain) between the treatment and active control arms at any time during the 16-week study.
adverse events
时间窗: 16 weeks
The safety of topically applying a plasma film containing metallic silver microparticles plus fibrin in patients with skin graft donor sites for 16 weeks following split-thickness skin grafting.
次要结局
- Percent wound healing(4 weeks)
- Scarring(16 weeks)
- Time to complete wound closure(4 weeks)
- Recurrent donor site wound after complete wound closure(16 weeks)
研究者
Hobart W. Harris
President
Vitruvian Medical Devices, Inc.