Post Surgical Incisions From Abdominoplasty Procedures
Conditions
Keywords
incision, abdominoplasty
Brief summary
This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients. The hypothesis is that this dressing will minimize scar formation.
Detailed description
This study will evaluate a new dressing in up to 30 patients who have undergone an abdominoplasty procedure. They will wear the dressing through 8 weeks post surgery and the scar will be evaluated at 3 months post surgery.
Interventions
DEVICEGLYDe Dressing
Wound dressing intended to minimize scar formation
Sponsors
Neodyne Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* subjects who have undergone an abdominoplasty 1 week prior to study participation
Exclusion criteria
* subjects with a history of collagen vascular disease or scleroderma * subjects with known adverse reactions to steri-strips, medical tapes or adhesives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control) | through 12 months | Professional photographs were taken 12 months postsurgery and evaluated by lay and professional panels. A 100 point Visual Analog Scale (VAS), ranging from a score of 0 for a better outcome to a score of 100 for worse outcome, will be used to assess both the Treated and Control scars at the same timepoint. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants The interventions provided consisted of a GLYDe dressing which was randomly assigned to the left or right side of the patient's abdomen. The opposite side of the intervention received the standard of care (SoC).
For example, one patient wore a GLYDe Dressing on Left Side, and SoC Right Side while another patient wore GLYDe Dressing Right Side, and SoC Left Side. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age, Continuous | 39.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 12 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control)
Professional photographs were taken 12 months postsurgery and evaluated by lay and professional panels. A 100 point Visual Analog Scale (VAS), ranging from a score of 0 for a better outcome to a score of 100 for worse outcome, will be used to assess both the Treated and Control scars at the same timepoint.
Time frame: through 12 months
Population: Patient population undergoing elective plastic surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GLYDe Dressing (Treated) | Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control) | 18.64 score on a scale | Standard Deviation 10.86 |
| SoC (Control) | Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control) | 50.52 score on a scale | Standard Deviation 15.17 |
Wilcoxon (Mann-Whitney)