Surgical WoundExceedNCT04740775
LiquiBand® Exceed™ and LiquiBand® Rapid™ for General Surgery Procedures
A study testing LiquiBand Exceed and LiquiBand Rapid in people with Surgical Wound, run by Advanced Medical Solutions Ltd. at 4 sites in United States.
Trial summary
The purpose of this post market study is to evaluate the performance and safety of LiquiBand® Exceed™ and LiquiBand® Rapid™ for closure of surgical incisions associated with abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound
- What is being tested?
- LiquiBand Exceed and LiquiBand Rapid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Nov 2022to 30 Sep 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who meet all of these criteria at time of enrollment may be included in the investigation:
- Subject is ≥ 18 years of age
- Subject is to undergo general abdominal surgery
- Planned incision(s) are expected to be 4cm or greater in length
- Subject is willing and able to comply with the protocol and follow up period
- Subject is willing and able to give written informed consent
Who cannot join
- Patients who meet any one of these criteria will be excluded from the study:
- Subject is pregnant or nursing
- Subject has inadequate or unsuitable tissue e.g. due to radiation damage, ulceration compromised vascularity, history of compromised wound heal.
- Subject has a sensitivity to cyanoacrylates or formaldehyde
- Subject has a known sensitivity to topical skin adhesives
- Subject has active or potential infection at the surgical site
Show all 10Show fewer
- Subject has a history of keloid formation
- Subject has a known vitamin C or zinc deficiency
- Subject has a connective tissue disorder
- Subject has uncontrolled diabetes mellitus
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Prisma Health
Greenville, South Carolina, 29605
Prisma Health
Greenville, South Carolina, 29607
Prisma Health
Greer, South Carolina, 29650
About this study
Official title: Clinical Study to Evaluate LiquiBand® Exceed™ and LiquiBand® Rapid™ for Closure of Surgical Incisions Associated With Abdominal Surgery
The purpose of this post market study is to evaluate the performance and safety of LiquiBand® Exceed™ and LiquiBand® Rapid™ for closure of surgical incisions associated with abdominal surgery.
Read the detailed description
LiquiBand® Exceed™ and LiquiBand® Rapid™ are the "study" devices. The study devices are an adhesive used to close surgical wounds. When the adhesive is applied to the skin, it polymerizes (forms a chemical bond) within minutes due to the moisture on the skin's surface and allows the wound edges to remain in the correct position. The use of the study devices are not "investigational" (experimental) because it is already cleared for doctors to use for surgical wound closure in the United States of America.
In this study, LiquiBand® Exceed™ and LiquiBand® Rapid™ will be used to close surgical wounds following general abdominal surgery. Subjects will be followed up for 14-days post surgery, and safety and performance of the study device will be evaluated.
- Conditions
- Surgical Wound
- Being tested
- LiquiBand Exceed, LiquiBand Rapid
- Keywords
- Topical Skin Adhesives,, Cyanoacrylate, LiquiBand Exceed, Wound Closure, LiquiBand Rapid
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiquiBand ExceedDevice
Cyanoacrylate glue for closure of surgical wounds
LiquiBand RapidDevice
Cyanoacrylate glue for closure of surgical wounds
| Study group | Role | What they receive |
|---|---|---|
| LiquiBand Exceed | Experimental | Surgical wound closure using the LiquiBand Exceed Topical Skin Adhesive Receives: Device: LiquiBand Exceed |
| Liquiband Rapid | Experimental | Surgical wound closure using the LiquiBand Rapid Topical Skin Adhesive Receives: Device: LiquiBand Rapid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of wound dehiscence
Proportion of subjects with evidence of partial or complete dehiscence assessed by the investigator
Measured: 14 days post-surgery
Secondary outcomes (3)
Safety of Liquiband Exceed, assessed by incidence of device-related AEs / SAEs
Proportion of subjects who experience at least one device-related AE/SAE
Measured: 14-days post-surgery
Surgeon satisfaction with the device
To be assessed by the investigator using a Likert scale at the time of surgery
Measured: Day 0
Cosmetic outcome
Investigator assessment of wound cosmesis using the Modified Hollander Wound Evaluation Scale (HWES).
This will be modified to a 6-point scale with one point assigned to any of the following observed wound appearances: step-off borders, contour irregularities, margin separation, edge inversion, excessive distortion, and overall appearance of wound. A HWES of 0 will indicate an optimal wound appearamce, with each point between 1 and 6 indicating a less adequate appearance of the wound.
Measured: 14-days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start8 Nov 2022
- Primary completion19 Mar 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm, non-comparative, open-label, prospective study
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Medical Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioStat International, Inc.
- Responsible party
- Sponsor
- Investigators
- Alfredo Carbonnell, MD, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740775
- Sponsor's protocol ID
- Exceed 01-2020
- Acronym
- Exceed
- Status last verified
- Dec 2024
- First submitted
- 2 Feb 2021
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate LiquiBand® Exceed™ and LiquiBand® Rapid™ for Closure of Surgical Incisions Associated With Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04740775
- Acronym / sponsor ID
- Exceed / Exceed 01-2020
- Conditions
- Surgical Wound
- Keywords
- Topical Skin Adhesives,, Cyanoacrylate, LiquiBand Exceed, Wound Closure, LiquiBand Rapid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Advanced Medical Solutions Ltd.Industry (pharma, biotech, devices)
- Collaborators
- BioStat International, Inc.
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 5 Feb 2021 (actual)
- 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.
The purpose of this post market study is to evaluate the performance and safety of LiquiBand® Exceed™ and LiquiBand® Rapid™ for closure of surgical incisions associated with abdominal surgery.
Detailed description
LiquiBand® Exceed™ and LiquiBand® Rapid™ are the "study" devices. The study devices are an adhesive used to close surgical wounds. When the adhesive is applied to the skin, it polymerizes (forms a chemical bond) within minutes due to the moisture on the skin's surface and allows the wound edges to remain in the correct position. The use of the study devices are not "investigational" (experimental) because it is already cleared for doctors to use for surgical wound closure in the United States of America.
In this study, LiquiBand® Exceed™ and LiquiBand® Rapid™ will be used to close surgical wounds following general abdominal surgery. Subjects will be followed up for 14-days post surgery, and safety and performance of the study device will be evaluated.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-arm, non-comparative, open-label, prospective study
| Arm | Type | Receives |
|---|---|---|
| LiquiBand Exceed | Experimental | Device: LiquiBand ExceedSurgical wound closure using the LiquiBand Exceed Topical Skin Adhesive |
| Liquiband Rapid | Experimental | Device: LiquiBand RapidSurgical wound closure using the LiquiBand Rapid Topical Skin Adhesive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who meet all of these criteria at time of enrollment may be included in the investigation:
- Subject is ≥ 18 years of age
- Subject is to undergo general abdominal surgery
- Planned incision(s) are expected to be 4cm or greater in length
- Subject is willing and able to comply with the protocol and follow up period
Key exclusion criteria (10 listed)
- Subject is pregnant or nursing
- Subject has inadequate or unsuitable tissue e.g. due to radiation damage, ulceration compromised vascularity, history of compromised wound heal.
- Subject has a sensitivity to cyanoacrylates or formaldehyde
- Subject has a known sensitivity to topical skin adhesives
- Subject has active or potential infection at the surgical site
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 |
|---|---|---|
| LiquiBand ExceedCyanoacrylate glue for closure of surgical wounds | Device | LiquiBand Exceed |
| LiquiBand RapidCyanoacrylate glue for closure of surgical wounds | Device | Liquiband Rapid |
Primary outcome
Incidence of wound dehiscence
Time frame: 14 days post-surgery
Proportion of subjects with evidence of partial or complete dehiscence assessed by the investigator
3 secondary outcomes
Safety of Liquiband Exceed, assessed by incidence of device-related AEs / SAEs
Time frame: 14-days post-surgery
Surgeon satisfaction with the device
Time frame: Day 0
Cosmetic outcome
Time frame: 14-days post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Alfredo Carbonnell, MD principal investigator
Prisma Health-Upstate
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiquiBand Exceed and LiquiBand Rapid in people with Surgical Wound, run by Advanced Medical Solutions Ltd. at 4 sites in United States.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of wound dehiscence (time frame: 14 days post-surgery). 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 28 Jan 2025.