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

NCT02584153 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: HiP_1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Hernia; Ventral; Incisional; Abdominal; Herniorrhaphy; Recurrence; laparotomy; prevention

Outcome Measures

Primary Outcomes (2)

• Wound Occurrences

  Wound events include surgical site infections as well as seromas/hematomas.

  6 months after surgery

• Post-operative Complications

  Post-operative complications include urinary tract infection and sepsis.

  6 months after surgery

Secondary Outcomes (1)

• Incisional Hernia

  1 month after surgery

Study Arms (1)

Myoseal

EXPERIMENTAL

The fibrin sealant and silver microparticles are sprayed onto the surface of the sutured myofascial incision following abdominal surgery.

Drug: Fibrin Sealant; Drug: Silver Microparticles

Interventions

Fibrin Sealant DRUG

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

Also known as: TISSUCOL/TISSEEL STIM3, TISSUCOL/TISSEEL STIM4, Fibrin Sealant VH S/D

Myoseal

Silver Microparticles DRUG

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

Also known as: Ag

Myoseal

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hobart Harris: lead

MeSH Terms

Conditions

Hernia; Hernia, Ventral; Hernia, Abdominal; Surgical Wound; Recurrence

Interventions

Fibrin Tissue Adhesive

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Fibrin; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Hobart W. Harris, M.D., M.P.H.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor & Chief, Division of General Surgery

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 22, 2015
• Study Start: January 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 6, 2020

Record last verified: 2020-02