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Tissue Adhesive
LiquiBand Products for Surgical Wounds (Exceed Trial)
N/A
Recruiting
Led By Alfredo Carbonnell, MD
Research Sponsored by Advanced Medical Solutions Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is to undergo general abdominal surgery
Subject is ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days post-surgery
Awards & highlights
Exceed Trial Summary
This trial will study the performance and safety of two types of surgical wound-closure products.
Who is the study for?
This trial is for adults over 18 who are having general abdominal surgery with incisions expected to be at least 4cm long. Participants must be able to follow the study's procedures and give consent. It's not for pregnant or nursing individuals, those with poor tissue quality, allergies to cyanoacrylates/formaldehyde, infection risks at the surgical site, history of keloid scars, vitamin C/zinc deficiencies, connective tissue disorders or uncontrolled diabetes.Check my eligibility
What is being tested?
The trial is assessing LiquiBand Exceed and LiquiBand Rapid for closing wounds after abdominal surgeries. The goal is to evaluate how well these adhesives work and their safety in a real-world setting post-market.See study design
What are the potential side effects?
Potential side effects may include allergic reactions if sensitive to cyanoacrylate or formaldehyde (ingredients in the adhesives), skin irritation around the wound site, increased risk of infection if not properly applied, and possibly abnormal scar formation.
Exceed Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for general surgery in my abdomen.
Select...
I am 18 years old or older.
Select...
My surgery will involve cuts that are at least 4cm long.
Exceed Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14-days post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14-days post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of wound dehiscence
Secondary outcome measures
Cosmetic outcome
Safety of Liquiband Exceed, assessed by incidence of device-related AEs / SAEs
Surgeon satisfaction with the device
Exceed Trial Design
2Treatment groups
Experimental Treatment
Group I: Liquiband RapidExperimental Treatment1 Intervention
Surgical wound closure using the LiquiBand Rapid Topical Skin Adhesive
Group II: LiquiBand ExceedExperimental Treatment1 Intervention
Surgical wound closure using the LiquiBand Exceed Topical Skin Adhesive
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Who is running the clinical trial?
Advanced Medical Solutions Ltd.Lead Sponsor
10 Previous Clinical Trials
1,426 Total Patients Enrolled
1 Trials studying Surgical Wound
66 Patients Enrolled for Surgical Wound
BioStat International, Inc.Industry Sponsor
1 Previous Clinical Trials
101 Total Patients Enrolled
Alfredo Carbonnell, MDPrincipal InvestigatorPrisma Health-Upstate
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for general surgery in my abdomen.I am 18 years old or older.I have a connective tissue disorder.My surgery will involve cuts that are at least 4cm long.I have an infection or might get one where I had surgery.My tissue is damaged, making it unsuitable for certain medical procedures.My diabetes is not under control.I am willing and able to follow the study's requirements.I have a confirmed deficiency in vitamin C or zinc.
Research Study Groups:
This trial has the following groups:- Group 1: Liquiband Rapid
- Group 2: LiquiBand Exceed
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available to patients for the clinical trial?
"Confirming the details of clinicaltrials.gov, this medical study is not presently accepting participants. Initially shared on September 1st 2022 and most recently updated August 4th 2022, no new patients are being recruited for now even though 85 other trials require them urgently."
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