Wounds
Conditions
Keywords
SkinAffix
Brief summary
Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.
Detailed description
Subjects were approached for recruitment in the ED when discussing closure options by the physician. Only subjects deemed appropriate for skin glue closures by their treating physician were approached.Subjects were followed at 48 hours post-procedure, 5-10 days, and at 14 days following the ED visit.
Interventions
PROCEDURESkin Affix
Sponsors
Medline Industries
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than 5 years of age * Requires the use of a surgical skin adhesive * Informed consent signed
Exclusion criteria
* Sensitivity to topical adhesive products or formaldehyde * Hx keloid formation, hypotension, diabetes, blood clotting disorders * Wound infections * mucosal surfaces or skin exposed to body fluids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Closure at Discharge | 14 days | Wounds remained closed following application of Skin Affix |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Following Application | 15 minutes Post Application | Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Skin Affix Surgical adhesive
Skin Affix | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Skin Affix |
|---|---|
| Age, Continuous | 33.1 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 9 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Wound Closure at Discharge
Wounds remained closed following application of Skin Affix
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Skin Affix | Wound Closure at Discharge | 100 percent of participants |
Secondary
Change in Pain Following Application
Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain.
Time frame: 15 minutes Post Application
Population: Participants were asked 15 min after application to rate any change in pain as decreased, increased or no change.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Skin Affix | Change in Pain Following Application | Increase in Pain | 8.6 percent of participants |
| Skin Affix | Change in Pain Following Application | Decrease in Pain | 22.9 percent of participants |
| Skin Affix | Change in Pain Following Application | No change in Pain | 57.1 percent of participants |