LiquiBand FIX8® for Hernia, Femoral

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cleveland Clinic, Weston, FL
Hernia, Femoral+4 More
LiquiBand FIX8® - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new surgical device may help reduce pain after hernia surgery.

See full description

Eligible Conditions

  • Hernia, Femoral
  • Groin Hernia
  • Inguinal Hernias
  • Hernia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether LiquiBand FIX8® will improve 1 primary outcome and 6 secondary outcomes in patients with Hernia, Femoral. Measurement will happen over the course of At the time of surgery..

Month 12
To evaluate the safety of LiquiBand FIX8® and control device for groin hernia repair by comparing incidence of adverse events in patients post laparoscopic groin hernia repair.
Month 12
To compare levels of pain experienced following laparoscopic (TEP and TAPP) groin hernia repair by LiquiBand FIX8® or control device, as measured by VAS.
At the time of surgery.
To compare the incidence of successful mesh fixation at the time of surgery with LiquiBand FIX8® versus control device.
To compare the incidence of successful peritoneal closure (TAPP repairs only) at the time of surgery for LiquiBand FIX8® versus control device.
Month 12
To evaluate the incidence of hernia recurrence in patients following laparoscopic (TEP and TAPP) hernia repair using LiquiBand FIX8® or control device.
Month 12
To evaluate the quality of life experienced by subjects following groin hernia repair by LiquiBand FIX8® or control as measured by the Carolinas Comfort Scale (CCS).
Month 12
To compare the change in pain following groin hernia repair by LiquiBand FIX8® to control device as measured by Visual Analog Scale (VAS) at baseline (worst pain experienced within 1 month of screening visit) and at six months post hernia repair.

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

AbsorbaTack™
1 of 2
LiquiBand FIX8®
1 of 2
Active Control
Experimental Treatment

This trial requires 284 total participants across 2 different treatment groups

This trial involves 2 different treatments. LiquiBand FIX8® is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

LiquiBand FIX8®
Device
LiquiBand FIX8® is an n-butyl-2-cyanoacrylate adhesive monomer and D&C Violet #2 dye
AbsorbaTack™
Device
AbsorbaTack™ is an absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessments will be intraoperatively, at discharge, and at 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months following surgery.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly assessments will be intraoperatively, at discharge, and at 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months following surgery. for reporting.

Closest Location

Cleveland Clinic - Weston, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Hernia, Femoral or one of the other 4 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
3D Max™ Mesh (Bard Inc.)
3D Max™ Light (Bard Inc.)
Is male or female, ≥22 years of age
Is willing and able to give written informed consent
Has a primary or recurrent groin hernia (unilateral or bilateral, inguinal or femoral)
Is currently scheduled and eligible for TAPP or TEP laparoscopic groin hernia repair (inguinal or femoral)
Hernia mesh to be used at the time of surgery is at least 4" x 6" in size and is one of the following;
Parietex™ 2D (order code starting with TEC) Flat Sheet Mesh (Medtronic)
Parietex™ 3D (order code starting with TET) Flat Sheet Mesh (Medtronic)
Is willing and able to comply with the protocol assessments at time of surgery and during the post surgical follow up period

Patient Q&A Section

How many people get hernia, femoral a year in the United States?

"Approximately 2.5 million cases of all forms of femoral hernias occur each year. The most frequent location of hernia is the groin region, with hernias occurring most commonly in women of childbearing age." - Anonymous Online Contributor

Unverified Answer

What are the signs of hernia, femoral?

"Symptoms of a hernia in a child include a bulging groin, groin pain, weakness of the thigh muscle, feeling that the testicles have fallen through the groin, and feeling that the testicles are moving or moving up and down. Sudden weakening of the thigh muscle and reduced movement of the thigh are more suggestive of a strangulated hernia. Symptoms typically appear during the first five to six months of life. On the abdominal examination, a strangulated hernia can be verified by finding a bulging bulge, and the testicles must lie within the inguinal canal (between and above the scrotum)." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hernia, femoral?

"Many patients with groin hernia or femoral vein thrombosis have been treated with a combination of antibiotics, anticoagulants, and thrombolytics, sometimes in outpatient settings. The use of these medications appears to be associated with prolongation of hospital stays and high rates of serious complications. Antibiotics, anticoagulants, and thrombolytics must not be used clinically for routine treatment of groin hernia and femoral vein thrombosis in an outpatient setting. Appropriate treatment for groin hernia and femoral vein thrombosis may involve medical management with a combination of low-dose heparin and/or compression stockings and surgery." - Anonymous Online Contributor

Unverified Answer

What causes hernia, femoral?

"The most plausible explanation for the observed findings is that the hernias represent the same anatomical entity as the femoral hernias. The herniation process seems to be related to the muscular structure of the aponeurosis of the femoral nerve or the muscular tissue of the inguinal canal. The herniation is not a result of a congenital defect, but may be developed after trauma, which causes a disruption of the nerve and ligamentous structures. Alternatively, it may be associated with anatomical anomalies, such as intestinal malrotation. Since hernias seem to be associated with an increase in abdominal circumference, it is also interesting to consider a correlation between hernias and body weight." - Anonymous Online Contributor

Unverified Answer

Can hernia, femoral be cured?

"While a significant number of hernia syndromes can be cured through proper repair, the most rewarding form of treatment is to find the cause of the hernia via the correct examination. At this time, hernioplasty is a palliative procedure and cannot be considered a cure for the underlying disorder." - Anonymous Online Contributor

Unverified Answer

What is hernia, femoral?

"A hernia may be an abdominal organ protruding through the inner of the thigh, it is an extremely common disorder and most common among women." - Anonymous Online Contributor

Unverified Answer

What is the latest research for hernia, femoral?

"[Hernia, femoral] clinical research should concentrate on developing a treatment plan that incorporates existing research and is as simple as possible. To achieve this, an effective communication between researchers and hospitals is essential." - Anonymous Online Contributor

Unverified Answer

Is liquiband fix8® typically used in combination with any other treatments?

"The majority of patients use Liquibalcon fix8(®) in conjunction with multiple other treatments. Combining Liquibalcon fix8(®) with multiple treatments can be more beneficial to patients with groin hernias." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hernia, femoral?

"The medical community still has much to learn and further research is necessary in order to find out the best surgical treatment for hernia, femoral. Recent research has shown the effect of using the natural compounds, plant extracts, and herbal formulas on hernia, femoral. As many of the above mentioned compounds have been shown not only to decrease the progression of the condition, but also alleviate the pain caused by the herniated organ, they act as the best surgical treatment. There is also still a great need for researchers to continue studying to find out how we can use the natural compounds to treat hernia, femoral." - Anonymous Online Contributor

Unverified Answer

How does liquiband fix8® work?

"Using a preoperative evaluation and surgical placement of 4 ml of Ligumab 8% solution, nearly 90% of patients were unable to find any difference in pain, function, strength, or range of motion when compared to preoperative evaluation and surgical placement without Ligumab 8% solution. Injectant, but not Ligumab 8% solution did produce significant decreases in pain, range of motion, and strength when compared to preoperative evaluation and surgical placement without injectant. The use of Ligumab 8% solution appeared to be safe and may facilitate recovery when injected into tissue." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of liquiband fix8®?

"These data support that the application of Liquiband Fix8(TM) in a clinical setting is an effective, safe treatment for the treatment of small incisional hernia." - Anonymous Online Contributor

Unverified Answer

Has liquiband fix8® proven to be more effective than a placebo?

"Liquiband fix8® was more effective than a control treatment on short-term pain alleviation and was preferred by patients. Furthermore, patients preferred their treatment over a placebo treatment regarding ease of use and safety. No statistically significant difference was found during follow-up period." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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