What side effects are associated with this type of intervention?

Medical adhesives such as LiquiBand® Exceed™ and LiquiBand® Rapid™ are commonly used for surgical wound closure. Known side effects of these adhesives include mild skin irritation, redness, and itching at the application site. In rare cases, patients may experience allergic reactions. These adhesives generally have a favorable safety profile with minimal severe adverse effects.

What prior FDA approvals exist?

The FDA has approved several medical adhesives for surgical wound closure, including cyanoacrylate-based products like Dermabond and Histoacryl. These adhesives are used to close incisions and lacerations by forming a strong bond that holds the wound edges together, promoting healing and reducing the need for sutures or staples. Similar to LiquiBand® Exceed™ and LiquiBand® Rapid™, these adhesives offer a non-invasive, quick, and effective method for wound closure, minimizing scarring and infection risk.

What other types of research exist?

Promising alternatives to LiquiBand® Exceed™ and LiquiBand® Rapid™ for surgical wound closure include: 1) Dermabond® PRINEO®: A combination of a topical skin adhesive and a self-adhering mesh that provides a strong, flexible wound closure. 2) TissuGlu®: An FDA-approved surgical adhesive for internal wound closure, particularly in abdominoplasty. 3) Histoacryl®: A cyanoacrylate-based adhesive that offers strong bonding and is used for various surgical applications. 4) Zip® Surgical Skin Closure: A non-invasive, adjustable device that provides uniform closure and reduces scarring. These alternatives have demonstrated effectiveness in clinical settings and offer different mechanisms of action to suit various surgical needs.

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Tissue Adhesive

LiquiBand Products for Surgical Wounds (Exceed Trial)

N/A

Waitlist Available

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

Must not have

Subject has a connective tissue disorder

Subject has active or potential infection at the surgical site

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days post-surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special medical glue called LiquiBand® Exceed™ and LiquiBand® Rapid™ for closing wounds after abdominal surgery. The glue works by reacting with skin moisture to quickly form a strong bond that holds the wound edges together. LiquiBand® has been used in various medical settings for wound closure. The study will follow patients for a short period after surgery to check how well and safely the glue works.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for general surgery in my abdomen.

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I am 18 years old or older.

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My surgery will involve cuts that are at least 4cm long.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a connective tissue disorder.

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I have an infection or might get one where I had surgery.

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My tissue is damaged, making it unsuitable for certain medical procedures.

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My diabetes is not under control.

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I have a confirmed deficiency in vitamin C or zinc.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14-days post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14-days post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14-days post-surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of wound dehiscence

Secondary study objectives

Cosmetic outcome

Safety of Liquiband Exceed, assessed by incidence of device-related AEs / SAEs

Surgeon satisfaction with the device

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Medical adhesives such as LiquiBand® Exceed™ and LiquiBand® Rapid™ are commonly used for surgical wound closure. These adhesives work by forming a strong bond between the edges of the wound, effectively sealing it and promoting faster healing. The adhesive acts as a barrier to protect the wound from infection and external contaminants. This method is particularly beneficial for patients as it reduces the need for sutures or staples, minimizes scarring, and often results in less pain and quicker recovery times. The use of medical adhesives is crucial for improving patient outcomes and enhancing the overall healing process of surgical wounds.

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