Surgical IncisionsNCT01835405
LiquiBand Versus Dermabond Versus Sutures for Closure of Surgical Wounds
A study testing LiquiBand Flex, Dermabond Advanced and Sutures (Prolene) in people with Surgical Incisions, run by Advanced Medical Solutions Ltd. at 1 site in United States.
Trial summary
To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical closure of surgical wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Incisions
- What is being tested?
- LiquiBand Flex, Dermabond Advanced and Sutures (Prolene)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2013to 14 Feb 2014
- 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
- Male or Female aged 18 or older on day of enrollment
- Scheduled for surgical procedure by a delegated study surgeon
- Fresh surgical wound with evenly distributed tension over length of incision
- Willing and able to sign informed consent
- Agree to return for 2 week (+/- 7 days) and 3 month (90 days +/- 7 days) post-procedure follow-up visit
Who cannot join
- Known sensitivity to cyanoacrylates, formaldehyde or acetone products
- Wounds in which incision edges are under high tension or not easily apposed (after deep layer suture), or over joints (unless immobilized)
- Wounds less than 15mm in length
- Wounds in which haemostasis is not able to be achieved, eg, drain is placed or Warfarin level >2.5 prior to surgery
- Wounds in which deep closure could not be achieved
- Surgical procedures involving mucus membranes or eyes
Show all 9Show fewer
- Mental incapacity, dementia, or inability to give informed consent
- Pregnant or nursing
- Disease related or pharmacologically immuno-compromised
Trial locations and contacts
1 site in 1 country.
United States1 site
Oncology Care Center, Beverly Hospital
Beverly, Massachusetts, 01915
About this study
Official title: A Prospective, Single-centre Study to Compare the Use of LiquiBand® Flex, Dermabond Advanced™ or Conventional Sutures for the Topical Closure of Surgical Wounds
To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical closure of surgical wounds.
- Conditions
- Surgical Incisions
- Being tested
- LiquiBand Flex, Dermabond Advanced, Sutures (Prolene)
- 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 FlexDevice
Dermabond AdvancedDevice
Sutures (Prolene)Device
| Study group | Role | What they receive |
|---|---|---|
| LiquiBand Flex | Active comparator | LiquiBand® Flex skin adhesive is indicated for topical application only, to hold closed easily approximated skin edges from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. It may be used in conjunction with, but not in place of deep dermal sutures. Receives: Device: LiquiBand Flex |
| Dermabond Advanced | Active comparator | Dermabond Advanced™ adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Dermabond Advanced ™ adhesive may be used in conjunction with, but not in place of, deep dermal stitches. Receives: Device: Dermabond Advanced |
| Sutures (Prolene) | Active comparator | Prolene™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. Receives: Device: Sutures (Prolene) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare cosmetic outcomes at follow up
Cosmesis to be evaluated by a panel of masked evaluators using a modified Hollander Wound Evaluation Scale
Measured: 3 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study start20 Feb 2013
- Primary completion14 Feb 2014
- Study completion14 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Medical Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01835405
- Sponsor's protocol ID
- D-LBF001-05-1
- Status last verified
- Jan 2017
- First submitted
- 12 Apr 2013
- Last updated
- 24 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-centre Study to Compare the Use of LiquiBand® Flex, Dermabond Advanced™ or Conventional Sutures for the Topical Closure of Surgical Wounds
- ClinicalTrials.gov ID
- NCT01835405
- Acronym / sponsor ID
- D-LBF001-05-1
- Conditions
- Surgical Incisions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Advanced Medical Solutions Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2013 (actual)
- Primary completion
- 14 Feb 2014 (actual)
- Study completion
- 14 Feb 2014 (actual)
- First posted
- 19 Apr 2013 (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.
To evaluate the cosmetic outcome, effectiveness, user and subject satisfaction, and safety of LiquiBand® Flex in relation to DermaBond Advanced™ and conventional sutures for the topical closure of surgical wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LiquiBand Flex | Active comparator | Device: LiquiBand FlexLiquiBand® Flex skin adhesive is indicated for topical application only, to hold closed easily approximated skin edges from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed trauma-induced lacerations. It may be used in conjunction with, but not in place of deep dermal sutures. |
| Dermabond Advanced | Active comparator | Device: Dermabond AdvancedDermabond Advanced™ adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Dermabond Advanced ™ adhesive may be used in conjunction with, but not in place of, deep dermal stitches. |
| Sutures (Prolene) | Active comparator | Device: Sutures (Prolene)Prolene™ Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female aged 18 or older on day of enrollment
- Scheduled for surgical procedure by a delegated study surgeon
- Fresh surgical wound with evenly distributed tension over length of incision
- Willing and able to sign informed consent
- Agree to return for 2 week (+/- 7 days) and 3 month (90 days +/- 7 days) post-procedure follow-up visit
Key exclusion criteria (9 listed)
- Known sensitivity to cyanoacrylates, formaldehyde or acetone products
- Wounds in which incision edges are under high tension or not easily apposed (after deep layer suture), or over joints (unless immobilized)
- Wounds less than 15mm in length
- Wounds in which haemostasis is not able to be achieved, eg, drain is placed or Warfarin level >2.5 prior to surgery
- Wounds in which deep closure could not be achieved
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 Flex | Device | LiquiBand Flex |
| Dermabond Advanced | Device | Dermabond Advanced |
| Sutures (Prolene) | Device | Sutures (Prolene) |
Primary outcome
To compare cosmetic outcomes at follow up
Time frame: 3 months post treatment
Cosmesis to be evaluated by a panel of masked evaluators using a modified Hollander Wound Evaluation Scale
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 24 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LiquiBand Flex, Dermabond Advanced and Sutures (Prolene) in people with Surgical Incisions, run by Advanced Medical Solutions Ltd. at 1 site 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 5 inclusion and 9 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 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
To compare cosmetic outcomes at follow up (time frame: 3 months post treatment). 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 24 Jan 2017.