Wounds
Conditions
Keywords
wounds
Brief summary
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.
Interventions
DEVICECyanoacrylate (Octylseal )
surgical adhesive
Sponsors
Medline Industries
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Candidate for use of a topical surgical skin adhesive
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Length Closure | During Surgery | Primary incision wound length treatment in adult and pediatric general surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Score of 0 (No Hurt) on the Pain Rating Scale | At Surgery | Pain was assessed using the Wong-Baker FACES™ Pain Rating Scale, with 0 =No Hurt to 10=Hurts Worst |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Octylseal | 34 |
| Total | 34 |
Baseline characteristics
| Characteristic | Octylseal |
|---|---|
| Age, Continuous Adult | 47.5 years STANDARD_DEVIATION 17.5 |
| Age, Continuous Pediatric | 11.3 years STANDARD_DEVIATION 2.8 |
| Region of Enrollment United States | 34 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 1 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
Primary
Wound Length Closure
Primary incision wound length treatment in adult and pediatric general surgery
Time frame: During Surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wound Length Closure of Paticipants Treated With Octylseal | Wound Length Closure | Adult | 28.97 milimeters | Standard Deviation 24.68 |
| Wound Length Closure of Paticipants Treated With Octylseal | Wound Length Closure | Pediatric | 21.00 milimeters | Standard Deviation 10.98 |
Secondary
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
Time frame: At Surgery
Population: All 34 participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wound Length Closure of Paticipants Treated With Octylseal | Number of Participants With a Score of 0 (No Hurt) on the Pain Rating Scale | 34 Participants |