Port-A-Cath PlacementNCT02212977
Comparison of Topical Skin Adhesive to Subcuticular Suture Closure of Implantable Port Incisions
A study testing Octylcyanoacrylate and Suture in people with Port-A-Cath Placement and Octylcyanoacrylate, run by Duke University at 1 site in United States.
Trial summary
Hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with stitches in Port a Cath patients, who, as a population, are at increased risk for complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Port-A-Cath Placement, Octylcyanoacrylate
- What is being tested?
- Octylcyanoacrylate and Suture
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients (≥18 years) who present for initial implantable port placement during the recruitment period will be eligible to participate in the study
Who cannot join
- Patients who cannot provide informed consent for the procedure will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with stitches in Port a Cath patients, who, as a population, are at increased risk for complications. All adult patients who present for initial Port a Cath placement during the recruitment period will be eligible to participate in the study. Subjects will be randomized to either skin incision closure with standard stitches or closure with skin glue. Time to complete skin closure and costs of closure will be compared. Patients will be evaluated approximately one month and three months from the procedure to assess for complications of wound breakdown or infection, as well as for the appearance of the Port a Cath incision.
- Conditions
- Port-A-Cath Placement, Octylcyanoacrylate
- Being tested
- Octylcyanoacrylate, Suture
- Keywords
- Port Catheter, Octyl 2-cyanoacrylate, 2-octylcyanoacrylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OctylcyanoacrylateDevice
Also called Octyl 2-cyanoacrylate, 2-octylcyanoacrylate
Skin incision closure with topic skin adhesive Octylcyanoacrylate
SutureProcedure or surgery
Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
| Study group | Role | What they receive |
|---|---|---|
| Suture | Active comparator | Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture Receives: Procedure: Suture |
| Octylcyanoacrylate | Experimental | Skin incision closure with topic skin adhesive Octylcyanoacrylate Receives: Device: Octylcyanoacrylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complication of Wound Dehiscence
To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.
Measured: 3 months
Number of Participants With Complication of Infection
To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.
Measured: 3 months
Secondary outcomes (3)
Healing-incision Cosmesis Score by Visual Analogue Scale
To compare resultant cosmesis with topic skin adhesive closure versus suture closure. Scale is 1-10 with 1 as the best possible outcome and 10 is the worst possible outcome.
Measured: 3 months
Closure Time
To compare closure time and associated costs between these two methods of skin closure.
Measured: Baseline
Closure Materials Cost
Per unit cost for suture and octylcyanoacrylate
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionOct 2015
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 Port-A-Cath PlacementStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles Kim, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212977
- Sponsor's protocol ID
- Pro00056064
- Status last verified
- Oct 2016
- First submitted
- 7 Aug 2014
- Last updated
- 18 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical Skin Adhesive to Subcuticular Suture Closure of Implantable Port Incisions
- ClinicalTrials.gov ID
- NCT02212977
- Acronym / sponsor ID
- Pro00056064
- Conditions
- Port-A-Cath Placement, Octylcyanoacrylate
- Keywords
- Port Catheter, Octyl 2-cyanoacrylate, 2-octylcyanoacrylate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 11 Aug 2014 (estimated)
- Results
- Posted 18 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with stitches in Port a Cath patients, who, as a population, are at increased risk for complications. All adult patients who present for initial Port a Cath placement during the recruitment period will be eligible to participate in the study. Subjects will be randomized to either skin incision closure with standard stitches or closure with skin glue. Time to complete skin closure and costs of closure will be compared. Patients will be evaluated approximately one month and three months from the procedure to assess for complications of wound breakdown or infection, as well as for the appearance of the Port a Cath incision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suture | Active comparator | Procedure: SutureSkin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture |
| Octylcyanoacrylate | Experimental | Device: OctylcyanoacrylateSkin incision closure with topic skin adhesive Octylcyanoacrylate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients (≥18 years) who present for initial implantable port placement during the recruitment period will be eligible to participate in the study
Key exclusion criteria (1 listed)
- Patients who cannot provide informed consent for the procedure will be excluded from the study.
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 |
|---|---|---|
| OctylcyanoacrylateAlso: Octyl 2-cyanoacrylate, 2-octylcyanoacrylateSkin incision closure with topic skin adhesive Octylcyanoacrylate | Device | Octylcyanoacrylate |
| SutureSkin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture | Procedure or surgery | Suture |
Primary outcome
Number of Participants With Complication of Wound Dehiscence
Time frame: 3 months
To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.
Number of Participants With Complication of Infection
Time frame: 3 months
To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.
3 secondary outcomes
Healing-incision Cosmesis Score by Visual Analogue Scale
Time frame: 3 months
Closure Time
Time frame: Baseline
Closure Materials Cost
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Charles Kim, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Octylcyanoacrylate and Suture in people with Port-A-Cath Placement and Octylcyanoacrylate, run by Duke University 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 1 inclusion and 1 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 18 Oct 2016. 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?
Yes. Results are posted in the registry (first posted 18 Oct 2016). 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?
Number of Participants With Complication of Wound Dehiscence (time frame: 3 months). The study lists 2 primary outcomes in all. 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 18 Oct 2016.