Early Clinical Outcomes of High-Purity Type I Collagen as a Biologic Reinforcement in Selected Hernia Repair Scenarios: A Prospective Clinical Study
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Adichunchanagiri Institute of Medical Sciences, B G Nagara
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With Early Postoperative Safety Events (Surgical Site Infection, Mesh-Related Adverse Events, or Reoperation)
概览
简要总结
This prospective, single-arm clinical study evaluates the safety, feasibility, and early clinical outcomes of High-Purity Type I Collagen (HPTC; Surgicoll-Mesh®) when used as a biologic reinforcement in selected hernia repair scenarios where permanent synthetic mesh placement is undesirable. Outcomes focus on early postoperative safety, wound healing, and complication profiles over an 8-week follow-up period.
详细描述
Synthetic mesh has reduced hernia recurrence but is associated with significant complications in contaminated fields and high-risk patients. Biologic meshes offer potential advantages including biocompatibility, resistance to infection, and tissue remodeling. High-Purity Type I Collagen (>97% purity) is an un-crosslinked, resorbable scaffold designed to support host tissue integration.
This prospective observational study systematically evaluates early clinical outcomes following HPTC-reinforced hernia repair, including surgical site infection, wound healing, postoperative pain, and early integrity of repair. The study is not designed to assess long-term recurrence.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Ventral, incisional, umbilical, or para-umbilical hernia
- •Contaminated or potentially contaminated surgical field
- •Hernia repair following infected mesh explantation
- •High-risk patients (diabetes, obesity, smoking, immunosuppression)
- •Ability to provide informed consent
排除标准
- •Clean, low-risk primary hernia suitable for synthetic mesh
- •Large defects requiring permanent load-bearing prosthesis
- •Generalized peritonitis or uncontrolled sepsis
- •Known collagen hypersensitivity
- •Pregnancy
- •Inability to comply with follow-up
研究组 & 干预措施
HPTC-Reinforced Hernia Repair
Participants undergo standard hernia repair with primary fascial closure where feasible, reinforced using High-Purity Type I Collagen mesh (Surgicoll-Mesh®). The biologic mesh is used as an adjunct reinforcement and not as a routine replacement for permanent synthetic mesh. Mesh placement (onlay or sublay) and peri-operative management are performed according to surgeon discretion and institutional protocols. The arm evaluates early postoperative safety, wound healing, and short-term clinical outcomes over an 8-week follow-up period in selected high-risk or contaminated hernia repair scenarios.
干预措施: High-Purity Type I Collagen Mesh (Device)
结局指标
主要结局
Number of Participants With Early Postoperative Safety Events (Surgical Site Infection, Mesh-Related Adverse Events, or Reoperation)
时间窗: Up to 8 weeks post-operatively
Incidence (number of participants) of surgical site infection, mesh-related adverse events, and need for re-intervention or mesh removal within 8 weeks postoperatively.
次要结局
- Number of Participants With Early Wound Complications (Seroma, Hematoma, or Wound Dehiscence)(Up to 8 weeks)
- Postoperative Change in Visual Analog Scale (VAS) Pain Scores(Baseline (preoperatively) to 8 weeks postoperatively)
- Early Clinical Integrity of Repair(Up to 8 weeks)
- Length of Hospital Stay(From immediately after the surgery until hospital discharge)
- Patient Satisfaction With Hernia Repair(8 weeks post-operatively)
- Hernia-Specific Quality of Life(Baseline and 8 weeks post-operatively)