Post Approval Study to Evaluate the Safety and Performance of GENTA-FOIL Resorb® for the Prevention of Tissue Adhesions in Hand Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 3
- 主要终点
- Restoration of hand mobility
研究概览
简要总结
Single arm study to evaluate the safety and performance of Genta-Foil resorb® for the prevention of tissue adhesions
详细描述
GENTA-FOIL resorb® is an implantable, absorbable collagen barrier foil, which forms a temporary barrier between the functional structures during the critical phase of wound healing. As a result, the ability of the tissue layers to slide against each other is retained.
The objective of hand surgery is to promote wound repair, and regeneration of all motor and sensory functions of the hand and to restore the subject's hand mobility, and improve their quality of life. However, hand trauma and operations often lead to the formation of adhesions between the various tissue layers of the hand (e.g. muscles, tendons and nerves). Even with minimally invasive procedures and optimal aftercare, development of adhesions in the suture and wound areas is often unavoidable. Adhesion formation between repaired tendons and the surrounding tissue has been thought to be one of the most important factors that disturbs functional restoration. It is estimated that the adhesion, which can cause significant disability, occurs in about 30% of cases.
The purpose of this study is to investigate the use of GENTA-FOIL resorb® for the prevention of tissue adhesions measured by restoration in digital function in subjects undergoing hand surgery. The functional outcome of tendon injury after a repair depends on multiple factors such as age, injury level and type, type of repair, and post repair therapy.
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
- •Subject is male or female, ≥18 years of age;
- •Subject is willing and able to give written informed consent;
- •Subject is scheduled for one if the following surgical procedures:
- •3a. extensor tendon repair zones I to VI.
- •3b. flexor tendon repair zones I to VI.
- •3c. open reduction and internal fixation to repair hand fractures of proximal phalanx, and/or middle phalanx, and/or metacarpals
- •Subject is willing and able to comply with the study procedures during surgery and the post-surgical follow up period.
排除标准
- •Subject is known to be sensitive to any of the device components e.g. Gentamicin (aminoglycosides) or equine collagen.
- •Subject is known to be non-compliant with medical treatment.
- •Subject has any known impaired renal function/autoimmune illness/neuromuscular disease (such as Parkinson's or Myasthenia Gravis).
- •Subject is currently taking an Aminoglycoside antibiotic as stand-alone treatment or in combination with other antibiotics
- •Subject is pregnant or actively breastfeeding.
- •Subject has active infection at surgical site
- •Subject has any significant or unstable medical or psychiatric condition that, in the opinion of the Investigator, would interfere with their ability to participate in the study, or affect the study outcomes.
- •Subject is currently enrolled in another clinical study that would interfere with their ability to participate in this study
结局指标
主要结局
Restoration of hand mobility
时间窗: At 90 days post-surgery
Restoration of hand mobility will be assessed using functional assessment scoring Total Active Motion (TAM) at 90 days post-surgery. This will be measured by the modified Strickland scoring criteria. The success criteria is defined as TAM score of 75% or above at 90 days post-surgery. Restriction of TAM post-surgery is indicative of tissue adhesions, therefore this measure will demonstrate presence / absence of of tissue adhesions.
次要结局
- Change in patient pain scores (assessed using VAS) up to 90 days post-surgery.(Up to 90 days post-surgery)
- Wound healing without complications up to 30 days post-surgery.(Up to 30 days)
- Incidence of device related infections at surgical site up to 30 days post-surgery.(Up to 30 days post-surgery)
- Incidence of device related adverse events(Up to 90 days post-surgery)
- Subjective assessment of symptoms and abilities to perform activities by 90 days post-surgery(At 90 days post-surgery)
- Clinicians' satisfaction with the device at time of surgery(Immediately post-surgery)