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Trial Outcomes & Findings for Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care (NCT NCT00766727)

NCT ID: NCT00766727

Last Updated: 2020-12-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

through 12 months

Results posted on

2020-12-14

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
12
Overall Study
COMPLETED
9
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Participants
n=12 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.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
12 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
39.5 years
n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
Race (NIH/OMB)
Asian
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
5 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
Region of Enrollment
United States
12 Participants
n=5 Participants

PRIMARY outcome

Timeframe: through 12 months

Population: Patient population undergoing elective plastic surgery.

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.

Outcome measures

Outcome measures
Measure
GLYDe Dressing (Treated)
n=9 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.
SoC (Control)
n=9 Participants
Standard of care treatment group, used as the control. 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 on Right Side while another patient wore GLYDe Dressing Right Side, and SoC on Left Side.
Scar Evaluation at End of Treatment Period Comparing Treated to Standard of Care (Control)
18.64 score on a scale
Standard Deviation 10.86
50.52 score on a scale
Standard Deviation 15.17

Adverse Events

GLYDe Dressing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

VP, R&D/OPS

Neodyne

Phone: 5104564128

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place