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An Open-label, Single-arm, Phase 1 Study Examining the Safety and Efficacy of Fibrin Sealant Plus Silver Microparticles to Prevent Incisional Hernias (HiP_1 Trial) Following Abdominal Surgery
Incisional hernias are a frequent consequence of abdominal surgery. Current clinical efforts are primarily focused on improving repair materials and surgical techniques to correct these hernias instead of the optimal solution: prevention. A product called MYOSEAL is currently being developed to prevent hernia formation after abdominal surgery by using fibrin tissue sealant and silver particles to prophylactically enhance the early wound healing of myofascial incisions. The purpose of this phase 1 study is to examine the safety of applying MYOSEAL immediately after abdominal wall suture closure in patients undergoing abdominal surgery. The investigators expect that applying this product to sutured myofascial incisions will increase collagen formation in the wound and thus prevent the formation of incisional hernias.
Details
| Lead sponsor | Hobart Harris |
|---|---|
| Phase | Phase 1 |
| Status | WITHDRAWN |
| Start date | 2019-01 |
| Completion | 2019-12 |
Conditions
- Hernia
- Ventral Hernia
- Abdominal Hernia
Interventions
- Fibrin Sealant
- Silver Microparticles
Primary outcomes
- Wound Occurrences — 6 months after surgery
Wound events include surgical site infections as well as seromas/hematomas. - Post-operative Complications — 6 months after surgery
Post-operative complications include urinary tract infection and sepsis.