A Phase 1 interventional study of Fibrin Sealant and Silver Microparticles in Hernia, Ventral Hernia and Abdominal Hernia, sponsored by Hobart Harris. Withdrawn. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-02-06.
Sponsored by Hobart Harris · Phase 1, Interventional, and Prevention
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.
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.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
Browse Hernia, Ventral studies →Hobart Harris is the lead sponsor of 2 studies on the registry; none are open to participants now.
Compared within Hernia, Ventral, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hernia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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Corticosteroids (steroids)
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Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
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Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
TISSEEL® fibrin sealant (Baxter Biosurgery, Deerfield, IL)
Also known as: TISSUCOL/TISSEEL STIM3, TISSUCOL/TISSEEL STIM4, Fibrin Sealant VH S/D
Product Code: AG-M-04M-P.200M (American Elements, Los Angeles, CA)
Also known as: Ag
Wound Occurrences
Wound events include surgical site infections as well as seromas/hematomas.
Time frame: 6 months after surgery
Post-operative Complications
Post-operative complications include urinary tract infection and sepsis.
Time frame: 6 months after surgery
Incisional Hernia
Incisional hernia as determined by the distance between the metal clips marking the myofascial edges on abdominal radiograph.
Time frame: 1 month after surgery
No study locations are listed for this record.
Start is estimated for Jan 2019; primary completion for Dec 2019, 11 months later.
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This study is withdrawn, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fibrin Tissue Adhesive
Hobart Harris