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

NCT02584153 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-02-06

No results posted yet for this study

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.

Conditions

  • Hernia
  • Ventral Hernia
  • Abdominal Hernia

Interventions

DRUG

Fibrin Sealant

TISSEEL® fibrin sealant (Baxter Biosurgery, Deerfield, IL)

DRUG

Silver Microparticles

Product Code: AG-M-04M-P.200M (American Elements, Los Angeles, CA)

Sponsors & Collaborators

  • Hobart Harris

    lead OTHER

Principal Investigators

  • Hobart W. Harris, M.D., M.P.H. · University of California, San Francisco

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-31
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02584153 on ClinicalTrials.gov