Wounds
Conditions
Keywords
Pediatric, Wounds
Brief summary
The purpose of this study is to evaluate the effectiveness of on-label use of Surgiseal™ Tissue Adhesive, a cyanoacrylate-based Surgical Topical Skin Tissue Adhesive in wound closure of the topical skin in children presenting in the Emergency Department (ED).
Detailed description
Subjects had SurgiSeal™ applied to their topical skin incisions in the ED. Subjects' wounds were evaluated for bleeding and closure of the incision/wound before patient discharge and 48 hours after the procedure. Further follow up wound closure evaluations were conducted via telephone interview at 5-10 days and 14 days after the ED visit.
Interventions
DEVICESurgiseal
surgical glue
Sponsors
Medline Industries
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the ages of 5 and 18 years of age, inclusive * Candidate for use of a topical surgical skin adhesive * Informed consent by a parental guardian
Exclusion criteria
* 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 body fluids or dense natural hair * Subjects with known hypersensitivity to cyanoacrylate or formaldehyde
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Wound Closure | baseline to 14 days | wound closure measured baseline to 14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Related to Wound Closure | 14 days | Adverse events reported |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surgical Glue Surgiseal
Surgiseal: surgical glue | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Surgical Glue |
|---|---|
| Age, Categorical <=18 years | 8 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Number of Participants With Wound Closure
wound closure measured baseline to 14 days
Time frame: baseline to 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wound Closure | Number of Participants With Wound Closure | 8 participants |
Secondary
Adverse Events Related to Wound Closure
Adverse events reported
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Wound Closure | Adverse Events Related to Wound Closure | 0 participants |