WoundsPhase 4NCT01514383
Octylseal Surgical Adhesive in General Surgery
A Phase 4 study testing Cyanoacrylate (Octylseal ) in people with Wounds, run by Medline Industries at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate how surgical adhesive is used. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Wounds
- What is being tested?
- Cyanoacrylate (Octylseal )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Oct 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Candidate for use of a topical surgical skin adhesive
Who cannot join
- Subjects with know sensitivity to topical surgical tissue adhesive products or degrading products (cyanoacrylates or formaldehyde)
- Subjects with a history of keloid formation, hypotension, insulin dependent diabetes mellitus, blood/clotting disorders, peripheral vascular diseases or hypertrophy history
- Subjects who present with a contraindications for product usage as per labeling
- A wound with evidence of active infection or gangrene or wounds of decubitus etiology
- Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to bodily fluids or with dense natural hair
- Subjects with known hypersensitivity to cyanoacrylate or formaldehyde
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jersey City Medical Center
Jersey City, New Jersey, 07302
Wyckoff Hospital
New York, New York, 11237
About this study
Official title: Evaluation of Octylseal as a Topical Surgical Skin Incision Adhesive in General Surgery: A Case Series
The purpose of this study is to evaluate how surgical adhesive is used.
Read the detailed description
In this Case Series Study, clinician experience and subject outcomes will be recorded in the use of a topical skin adhesive (Octylseal) on the closure of skin incisions from General surgical procedures.
- Conditions
- Wounds
- Being tested
- Cyanoacrylate (Octylseal )
- Keywords
- wounds
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyanoacrylate (Octylseal )Device
Also called cyanoacrylate
surgical adhesive
| Study group | Role | What they receive |
|---|---|---|
| Surgical Adhesive | Experimental | The surgical adhesive (cyanoacrylate) will be used once to close the topical skin surgical incision created during surgical procedures. Receives: Device: Cyanoacrylate (Octylseal ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Length Closure
Primary incision wound length treatment in adult and pediatric general surgery
Measured: During Surgery
Secondary outcomes (1)
Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale
Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst
Measured: At Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for WoundsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ed Drower, MS, Study director, Medline Industries
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514383
- Sponsor's protocol ID
- R11-009
- Status last verified
- May 2019
- First submitted
- 12 Jan 2012
- Last updated
- 7 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Octylseal as a Topical Surgical Skin Incision Adhesive in General Surgery: A Case Series
- ClinicalTrials.gov ID
- NCT01514383
- Acronym / sponsor ID
- R11-009
- Conditions
- Wounds
- Keywords
- wounds
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 23 Jan 2012 (estimated)
- Results
- Posted 7 May 2019
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 study is to evaluate how surgical adhesive is used.
Detailed description
In this Case Series Study, clinician experience and subject outcomes will be recorded in the use of a topical skin adhesive (Octylseal) on the closure of skin incisions from General surgical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical Adhesive | Experimental | Device: Cyanoacrylate (Octylseal )The surgical adhesive (cyanoacrylate) will be used once to close the topical skin surgical incision created during surgical procedures. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Candidate for use of a topical surgical skin adhesive
Key exclusion criteria (6 listed)
- Subjects with know sensitivity to topical surgical tissue adhesive products or degrading products (cyanoacrylates or formaldehyde)
- Subjects with a history of keloid formation, hypotension, insulin dependent diabetes mellitus, blood/clotting disorders, peripheral vascular diseases or hypertrophy history
- Subjects who present with a contraindications for product usage as per labeling
- A wound with evidence of active infection or gangrene or wounds of decubitus etiology
- Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to bodily fluids or with dense natural hair
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 |
|---|---|---|
| Cyanoacrylate (Octylseal )Also: cyanoacrylatesurgical adhesive | Device | Surgical Adhesive |
Primary outcome
Wound Length Closure
Time frame: During Surgery
Primary incision wound length treatment in adult and pediatric general surgery
1 secondary outcome
Number of Participants With a Score of "0" (No Hurt) on the Pain Rating Scale
Time frame: At Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Wounds
Not yet recruitingPhase 4
Propofol Target-Controlled Infusion Versus Dexmedetomidine for Sedation During Chronic Subdural Hematoma Surgery Under Local Anesthesia
Chronic Subdural Hematoma
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Recruiting
Trial of Social Work Services in Fracture Clinic Setting
Orthopaedic Fractures, Socioeconomic Factors
Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
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.
Ed Drower, MS study director
Medline Industries
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyanoacrylate (Octylseal ) in people with Wounds, run by Medline Industries at 2 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 1 inclusion and 6 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wound Length Closure (time frame: During 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 7 May 2019.