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

• Status: Withdrawn
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hobart Harris
• Treatments: Fibrin Tissue Adhesive

Criteria

Inclusion Criteria:

• The patient is undergoing an abdominal operation requiring an incision ≥10-cm in length;

• Age ≥21;

• Negative pregnancy test;

• No allergic, religious or ethical objections to fibrin tissue sealants (human blood proteins), aprotinin or metallic silver;

• Signed informed consent to take part in the study

Exclusion Criteria:

• Lactating women;

• Patients who are unable to commit to the follow evaluations over 6 months;

• Severe malnutrition (serum albumin <2.0);

• Use of an investigational agent within 1 month prior to study enrollment and/or planned during this study;

• Immunocompromised patients, as evidenced by: administration of high doses of corticosteroids (i.e. doses ≥ 1.5 mg/kg/day of prednisone or equivalent) within 72 hours before study enrollment; status post solid organ transplant or bone marrow transplant AND experiencing acute organ rejection or bone marrow failure or rejection; evidence of neutropenia (absolute neutrophil count ≤ 500 cells/mm3 (≤ 500 x 106 cells/L); immunosuppression secondary to immunomodulatory medications (e.g. cyclosporin, azathioprine, OKT3), chemotherapy or radiation therapy within 90 days before study enrollment; known AIDS; any disease sufficiently advanced to suppress resistance to infection (including, but not limited to leukemia, lymphoma or hypogammaglobulinemia); administration of immunoglobulin of G-CSF within 90 days before study enrollment;

• Presence of an underlying disease/injury with life expectancy less than two years and/or severe underlying disease that would preclude study entry (e.g. known malignancy).