Trial Outcomes & Findings for Closure After Total Shoulder Arthroplasty: Prineo vs Dermabond (NCT NCT03899753)
NCT ID: NCT03899753
Last Updated: 2023-07-03
Results Overview
A stopwatch will be used to measure the time it takes for the incision to be closed. When the surgical implants are in place and irrigation is complete, the surgeon will announce that he will start the closure and a nurse will start the stopwatch to measure how long it takes for the surgeon to close the incision.
TERMINATED
NA
1 participants
During surgery (approximately 40 minutes)
2023-07-03
Participant Flow
Participant milestones
| Measure |
2-Octyl Cyanoacrylate and Mesh
The wound will be closed with 2-Octyl Cyanoacrylate and a mesh
2-Octyl Cyanoacrylate and Mesh: 2-Octyl Cyanoacrylate and a mesh will be applied to final closure of wounds after undergoing a Total Shoulder Arthroplasty
|
2-Octyl Cyanoacrylate
The wound will be closed with just 2-Octyl Cyanoacrylate
2-Octyl Cyanoacrylate: Incisions will be closed with 2-Octyl Cyanoacrylate after undergoing a Total shoulder arthroplasty
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Only 1 participant was enrolled into the study. In the interest of safeguarding the identity of this individual, participant age is not being disclosed.
Baseline characteristics by cohort
| Measure |
2-Octyl Cyanoacrylate and Mesh
n=1 Participants
The wound will be closed with 2-Octyl Cyanoacrylate and a mesh
2-Octyl Cyanoacrylate and Mesh: 2-Octyl Cyanoacrylate and a mesh will be applied to final closure of wounds after undergoing a Total Shoulder Arthroplasty
|
2-Octyl Cyanoacrylate
The wound will be closed with just 2-Octyl Cyanoacrylate
2-Octyl Cyanoacrylate: Incisions will be closed with 2-Octyl Cyanoacrylate after undergoing a Total shoulder arthroplasty
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
Only 1 participant was enrolled into the study. In the interest of safeguarding the identity of this individual, participant age is not being disclosed.
|
—
|
0 Participants
Only 1 participant was enrolled into the study. In the interest of safeguarding the identity of this individual, participant age is not being disclosed.
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
Only 1 participant was enrolled into the study. In the interest of safeguarding the identity of this individual, participant age is not being disclosed.
|
—
|
0 Participants
Only 1 participant was enrolled into the study. In the interest of safeguarding the identity of this individual, participant age is not being disclosed.
|
|
Age, Categorical
>=65 years
|
0 Participants
Only 1 participant was enrolled into the study. In the interest of safeguarding the identity of this individual, participant age is not being disclosed.
|
—
|
0 Participants
Only 1 participant was enrolled into the study. In the interest of safeguarding the identity of this individual, participant age is not being disclosed.
|
|
Sex: Female, Male
Female
|
—
|
—
|
0 Participants
Only 1 participant was enrolled into the study. In the interest of safeguarding the identity of this individual, gender is not being disclosed.
|
|
Sex: Female, Male
Male
|
—
|
—
|
0 Participants
Only 1 participant was enrolled into the study. In the interest of safeguarding the identity of this individual, gender is not being disclosed.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
1 participants
n=1 Participants
|
—
|
1 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: During surgery (approximately 40 minutes)Population: Data was not collected/aggregated and therefore not analyzed.
A stopwatch will be used to measure the time it takes for the incision to be closed. When the surgical implants are in place and irrigation is complete, the surgeon will announce that he will start the closure and a nurse will start the stopwatch to measure how long it takes for the surgeon to close the incision.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediately post surgeryPopulation: Data was not collected/aggregated and therefore not analyzed.
Cost of closure will be assessed by the cost of the time in the operating room and the cost of materials used to close the incision
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At each follow up visit up to 3 months after surgeryPopulation: Data was not collected/aggregated and therefore not analyzed.
The surgeon and participant will fill out the Patient and Observer Scar Assessment Scale (POSAS). This is a survey used to assess the participant and the surgeons opinion of the appearance of the wound. The Patient and Observer Scar Assessment Scale (POSAS) is a questionnaire that was developed to assess scar quality. It consists of two separate six-item scales (Observer Scale and Patient Scale), both of which are scored on a 10-point rating scale. Each questionnaire consists of 7 questions, each graded 1 through 10. The minimum score is 7 (most like normal skin) and the maximum score is 70 (very different from normal skin). The observer is the surgeon. The observer and patient scores can then be added together to determine the collective score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At each follow up visit up to 3 months after surgeryPopulation: Data was not collected/aggregated and therefore not analyzed.
The wound will be assessed for dehiscence (incision opening) which will be recorded as a "yes or no". A dehiscence is defined as exposure of the underlying subcutaneous fat secondary to failure of the epidermal healing and may be accompanied by persistent wound drainage. It will be assessed by the length of the opening in centimeters and then normalized against the length of the entire incision. Furthermore, the number of wounds that open will be reported
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At first post operative visitPopulation: Data was not collected/aggregated and therefore not analyzed.
Dressing for each participant after surgery will be regulated and changed by the surgeon at the first post op visit. Drainage will be measured by outlining the drainage on gauze onto graph paper and measuring the area as previously validated in prior studies
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At each follow up visit up to 3 months after surgeryPopulation: Data was not collected/aggregated and therefore not analyzed.
Number of wounds with superficial skin infections will be reported
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At each follow up visit up to 3 months after surgeryPopulation: Data was not collected/aggregated and therefore not analyzed.
Number of deep wound infections found will be reported
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At each follow up visit up to 3 months after surgeryPopulation: Data was not collected/aggregated and therefore not analyzed.
Will report the number of wounds that require post operative intervention
Outcome measures
Outcome data not reported
Adverse Events
2-Octyl Cyanoacrylate and Mesh
2-Octyl Cyanoacrylate
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place