Octylcyanoacrylate, Port-A-Cath Placement
Conditions
Keywords
Port Catheter, Octyl 2-cyanoacrylate, 2-octylcyanoacrylate
Brief 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. 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.
Interventions
DEVICEOctylcyanoacrylate
Skin incision closure with topic skin adhesive Octylcyanoacrylate
PROCEDURESuture
Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients (≥18 years) who present for initial implantable port placement during the recruitment period will be eligible to participate in the study
Exclusion criteria
* Patients who cannot provide informed consent for the procedure will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complication of Wound Dehiscence | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healing-incision Cosmesis Score by Visual Analogue Scale | 3 months | 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. |
| Closure Time | Baseline | To compare closure time and associated costs between these two methods of skin closure. |
| Closure Materials Cost | Baseline | Per unit cost for suture and octylcyanoacrylate |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Suture Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture | 55 |
| Octylcyanoacrylate Skin incision closure with topic skin adhesive Octylcyanoacrylate
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate | 54 |
| Total | 109 |
Baseline characteristics
| Characteristic | Suture | Octylcyanoacrylate | Total |
|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 7.5 | 58.3 years STANDARD_DEVIATION 7.6 | 58.7 years STANDARD_DEVIATION 7.6 |
| Sex: Female, Male Female | 46 Participants | 35 Participants | 81 Participants |
| Sex: Female, Male Male | 9 Participants | 19 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 55 | 0 / 54 |
| serious Total, serious adverse events | 0 / 55 | 0 / 54 |
Outcome results
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Suture | Number of Participants With Complication of Infection | 2 participants |
| Octylcyanoacrylate | Number of Participants With Complication of Infection | 1 participants |
Primary
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.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Suture | Number of Participants With Complication of Wound Dehiscence | 0 participants |
| Octylcyanoacrylate | Number of Participants With Complication of Wound Dehiscence | 0 participants |
Secondary
Closure Materials Cost
Per unit cost for suture and octylcyanoacrylate
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Suture | Closure Materials Cost | 2.54 dollars |
| Octylcyanoacrylate | Closure Materials Cost | 25.92 dollars |
Secondary
Closure Time
To compare closure time and associated costs between these two methods of skin closure.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture | Closure Time | 8.6 minutes | Standard Deviation 3.7 |
| Octylcyanoacrylate | Closure Time | 1.6 minutes | Standard Deviation 0.8 |
Secondary
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.
Time frame: 3 months
Population: Only participants who completed the Healing-incision cosmesis score by Visual Analogue Scale were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Suture | Healing-incision Cosmesis Score by Visual Analogue Scale | 4.46 units on a scale | Standard Deviation 2.4 |
| Octylcyanoacrylate | Healing-incision Cosmesis Score by Visual Analogue Scale | 4.4 units on a scale | Standard Deviation 2.6 |