HerniaPhase 1HiP_1NCT02584153
A Study of Fibrin Sealant Plus Silver Microparticles to Prevent Incisional Hernias Following Abdominal Surgery
A Phase 1 study testing Fibrin Sealant and Silver Microparticles in people with Hernia and Ventral Hernia, run by Hobart Harris.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hernia, Ventral Hernia, Abdominal Hernia
- What is being tested?
- Fibrin Sealant and Silver Microparticles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2019to Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
About this study
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
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.
Read the 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.
- Conditions
- Hernia, Ventral Hernia, Abdominal Hernia
- Being tested
- Fibrin Sealant, Silver Microparticles
- Keywords
- Hernia, Ventral, Incisional, Abdominal, Herniorrhaphy, Recurrence, laparotomy, prevention
- Medical subject headings
- Hernia, Hernia, Ventral, Hernia, Abdominal, Surgical Wound, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin SealantDrug
Also called TISSUCOL/TISSEEL STIM3, TISSUCOL/TISSEEL STIM4, Fibrin Sealant VH S/D
TISSEEL® fibrin sealant (Baxter Biosurgery, Deerfield, IL)
Silver MicroparticlesDrug
Also called Ag
Product Code: AG-M-04M-P.200M (American Elements, Los Angeles, CA)
| Study group | Role | What they receive |
|---|---|---|
| Myoseal | Experimental | The fibrin sealant and silver microparticles are sprayed onto the surface of the sutured myofascial incision following abdominal surgery. Receives: Drug: Fibrin Sealant; Drug: Silver Microparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Occurrences
Wound events include surgical site infections as well as seromas/hematomas.
Measured: 6 months after surgery
Post-operative Complications
Post-operative complications include urinary tract infection and sepsis.
Measured: 6 months after surgery
Secondary outcomes (1)
Incisional Hernia
Incisional hernia as determined by the distance between the metal clips marking the myofascial edges on abdominal radiograph.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startJan 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Did not obtain IND or IRB approval to initiate study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hobart Harris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hobart Harris, University of California, San Francisco
- Investigators
- Hobart W. Harris, M.D., M.P.H., Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584153
- Sponsor's protocol ID
- HiP_1
- Acronym
- HiP_1
- Status last verified
- Feb 2020
- First submitted
- 19 Oct 2015
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02584153
- Acronym / sponsor ID
- HiP_1 / HiP_1
- Conditions
- Hernia, Ventral Hernia, Abdominal Hernia
- Keywords
- Hernia, Ventral, Incisional, Abdominal, Herniorrhaphy, Recurrence, laparotomy, prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Did not obtain IND or IRB approval to initiate study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hobart HarrisUniversity, hospital or other
- Study start
- Jan 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myoseal | Experimental | Drug: Fibrin Sealant, Drug: Silver MicroparticlesThe fibrin sealant and silver microparticles are sprayed onto the surface of the sutured myofascial incision following abdominal surgery. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrin SealantAlso: TISSUCOL/TISSEEL STIM3, TISSUCOL/TISSEEL STIM4, Fibrin Sealant VH S/DTISSEEL® fibrin sealant (Baxter Biosurgery, Deerfield, IL) | Drug | Myoseal |
| Silver MicroparticlesAlso: AgProduct Code: AG-M-04M-P.200M (American Elements, Los Angeles, CA) | Drug | Myoseal |
Primary outcome
Wound Occurrences
Time frame: 6 months after surgery
Wound events include surgical site infections as well as seromas/hematomas.
Post-operative Complications
Time frame: 6 months after surgery
Post-operative complications include urinary tract infection and sepsis.
1 secondary outcome
Incisional Hernia
Time frame: 1 month after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
Related trials for Hernia
Not yet recruitingObservational study
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Abdominal Aortic Aneurysm, Morbid Obesity
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Gastroschisis
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hobart W. Harris, M.D., M.P.H. principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fibrin Sealant and Silver Microparticles in people with Hernia and Ventral Hernia, run by Hobart Harris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Occurrences (time frame: 6 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.