drugset / Trial / NCT02584153

A Study of Fibrin Sealant Plus Silver Microparticles to Prevent Incisional Hernias Following Abdominal Surgery

NCT02584153

Phase 1 Withdrawn Hobart Harris
NaSingle-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2019-01
Primary completion
2019-12
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Subject AG-M-04M-P.200M Other / unclassified
Subject Fibrinogen Concentrate Human Protein / enzyme biologic

Indications

No indication recorded.