Pilot Study to Evaluate Clinical Outcomes With the Use of Biovance, a Dehydrated Decellularized Human Amnion Membrane Allograft, Following Keloid Revision Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Incidence of keloid scar recurrence after revision surgery with placement of Biovance
研究概览
简要总结
The main purpose of this study is to see if there is clinical benefit of using Biovance in reduction of the recurrence of keloids when used to revise them. It will also assess the postoperative complications.
详细描述
To assess the performance of Biovance, patients will consulted regarding the history and previous treatment of their keloid. Once patients are deemed to be appropriate candidates, they will be enrolled in the study. Operatively, the old scar will be completely excised. Then the Biovance will be laid in the base of the wound. After this is performed, extensive undermining will be done to close the wound in layers.
All post-revision complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis) will be assessed and recorded by the investigator. Patients will be reviewed to obtain demographic and risk factor (such as age, body mass index, smoking) data. Data on adjuvant therapy use (previous surgeries, treatments for keloid scar) will be collected. Surgical technique details (such as incision size and closure technique) will also be recorded for each patient. Photographs documenting the pre-, intra- and post-revision clinical course of patients will be collected.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject has:
- •been diagnosed with a keloid scar
- •a keloid scar that is located on the face, neck, arm, trunk, or groin area
- •is between the ages of 21 and 80 years old
- •competency as an adult, per applicable state law who is willing to provide written informed consent
- •the intent and ability to return for all scheduled and required visits and follow recommended standard post surgical treatment for keloid scar excision.
排除标准
- •The subject has:
- •clinical evidence of infection of the keloid scar
- •any malignancy or a neoplasm at the keloid scar site
- •any significant comorbid disease that may interfere with wound healing, known active Hepatitis A, B, or C or Acquired Immune Deficiency Syndrome or is known to be infected with HIV, a known collagen disorder or autoimmune disease [including systemic lupus erythematosis (SLE), rheumatoid arthritis (RA),fibromyalgia, polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of Sjogren, Larsen, Raynaud, Ehlers-Danlos or Marfan syndrome]
- •received chemotherapy, radiotherapy, immunosuppressives or corticosteroids (greater than 10 mg prednisone-equivalent per day) within the past 30 days.
- •a known history of abuse of alcohol or drugs (prescribed or illegal), significant psychiatric personality or psychotic disorder requiring chronic psychotropic therapy, or gross noncompliance to recommended therapies
- •condition(s) that would adversely affect subject safety by following the protocol
- •any contraindication for use of Biovance
结局指标
主要结局
Incidence of keloid scar recurrence after revision surgery with placement of Biovance
时间窗: 1 year post-surgery
Published data in the literature reporting on keloid scar incidence and recurrence without the use of Biovance may serve as a reference/historical control.
次要结局
- Incidence of complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis following revision surgery(1 year post-surgery)
- Clinical outcomes of keloid scar revision surgery, including scar size and appearance(1 year post-surgery)