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A Study of Fibrin Sealant Plus Silver Microparticles to Prevent Incisional Hernias Following Abdominal Surgery (HiP_1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02584153
Recruitment Status : Withdrawn (Did not obtain IND or IRB approval to initiate study.)
First Posted : October 22, 2015
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Hobart Harris, University of California, San Francisco

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.


Condition or disease Intervention/treatment Phase
Hernia Ventral Hernia Abdominal Hernia Drug: Fibrin Sealant Drug: Silver Microparticles Phase 1

Detailed Description:

Hernias are areas of weakness in the muscle of the abdomen and commonly develop after people have had abdominal surgery. This area of weakness often turns into a bulge or protrusion that can increase in size over time, interfere with the intestines and make it difficult for people to work or exercise. Many people undergo surgery to fix their hernia. Unfortunately, the operations to repair the hernia frequently fail and the hernia returns. The investigators are developing a material to help the body heal after abdominal surgery and thereby prevent incisional hernias for forming in the first place. This study is the first step in testing this new material in patients and whether it is safe to use. This study will include patients having all types of abdominal surgeries.

The test material is called MYOSEAL; a combination of a tissue sealant called TISSEEL® (Baxter Biosurgery, Deerfield, IL) plus small particles of metallic silver (<250µ, American Elements, Los Angeles, CA). TISSEEL is made from naturally occurring blood proteins and has been approved by the Food and Drug Administration (FDA) for use in surgery since 1998. But, TISSEEL has not been approved to prevent incisional hernias after abdominal surgery. The silver particles are not approved by FDA, but are thought to be generally safe in the way they will be used. This study hopes to learn how to help the body better heal after abdominal surgery.

At the conclusion of a laparotomy, 4-6 pairs of stainless steel clips (large Horizon® titanium clips, Teleflex Medical, Research Triangle Park, NC) will be attached opposite each other and equally spaced to the edges of the sutured myofascial incision, followed by the application of MYOSEAL to the sutured myofascial incision before closure of the skin. Study participants will be examined at 1 day, 1 month, 3 months, and 6 months after surgery. The primary endpoints include wound occurrences, including wound infections, seromas, and hematomas and postoperative complications through 6 months following surgery. The secondary endpoint is the incisional hernia rate at 1 month as determined by the distance between the metal clips marking the myofascial edges using calipers and a plain abdominal radiograph.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Myoseal
The fibrin sealant and silver microparticles are sprayed onto the surface of the sutured myofascial incision following abdominal surgery.
Drug: Fibrin Sealant
TISSEEL® fibrin sealant (Baxter Biosurgery, Deerfield, IL)
Other Names:
  • TISSUCOL/TISSEEL STIM3
  • TISSUCOL/TISSEEL STIM4
  • Fibrin Sealant VH S/D

Drug: Silver Microparticles
Product Code: AG-M-04M-P.200M (American Elements, Los Angeles, CA)
Other Name: Ag




Primary Outcome Measures :
  1. Wound Occurrences [ Time Frame: 6 months after surgery ]
    Wound events include surgical site infections as well as seromas/hematomas.

  2. Post-operative Complications [ Time Frame: 6 months after surgery ]
    Post-operative complications include urinary tract infection and sepsis.


Secondary Outcome Measures :
  1. Incisional Hernia [ Time Frame: 1 month after surgery ]
    Incisional hernia as determined by the distance between the metal clips marking the myofascial edges on abdominal radiograph.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584153


Sponsors and Collaborators
Hobart Harris
Investigators
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Principal Investigator: Hobart W. Harris, M.D., M.P.H. University of California, San Francisco
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Responsible Party: Hobart Harris, Professor & Chief, Division of General Surgery, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02584153    
Other Study ID Numbers: HiP_1
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hobart Harris, University of California, San Francisco:
Hernia
Ventral
Incisional
Abdominal
Herniorrhaphy
Recurrence
laparotomy
prevention
Additional relevant MeSH terms:
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Hernia
Hernia, Ventral
Incisional Hernia
Hernia, Abdominal
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants