MedDataX Logo

Trial Outcomes & Findings for NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test (NCT NCT03522675)

NCT ID: NCT03522675

Last Updated: 2019-05-31

Results Overview

Wheal formation is defined as a raised, pale, itchy formation (allergic reaction) on the skin's surface. A positive (+) allergic response would be indicated by the NeoMatriXTM Wound Matrix producing a wheal \>3 mm of the positive control (histamine).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

15 minutes

Results posted on

2019-05-31

Participant Flow

Participant milestones

Participant milestones
Measure
NeoMatriX and Two Comparators
NeoMatriX Wound Matrix Collagen Dressing 8mm disc Histamine positive control (0.1mL) Normal saline negative control (0.1mL) NeoMatriX Wound MatriX Collagen Dressing: Collagen wound dressing
Overall Study
STARTED
22
Overall Study
COMPLETED
20
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
NeoMatriX and Two Comparators
NeoMatriX Wound Matrix Collagen Dressing 8mm disc Histamine positive control (0.1mL) Normal saline negative control (0.1mL) NeoMatriX Wound MatriX Collagen Dressing: Collagen wound dressing
Overall Study
Screen fail
1
Overall Study
Non-reactive to histamine
1

Baseline Characteristics

NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
NeoMatriX and Two Comparators
n=20 Participants
NeoMatriX Wound Matrix Collagen Dressing 8mm disc Histamine positive control (0.1mL) Normal saline negative control (0.1mL) NeoMatriX Wound MatriX Collagen Dressing: Collagen wound dressing
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
38.35 years
n=5 Participants
Sex: Female, Male
Female
13 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
20 participants
n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes

Wheal formation is defined as a raised, pale, itchy formation (allergic reaction) on the skin's surface. A positive (+) allergic response would be indicated by the NeoMatriXTM Wound Matrix producing a wheal \>3 mm of the positive control (histamine).

Outcome measures

Outcome measures
Measure
NeoMatriX Alone
n=20 Participants
NeoMatriX Wound Matrix Collagen Dressing 8mm disc NeoMatriX Wound MatriX Collagen Dressing: Collagen wound dressing
Positive Control
n=20 Participants
Histamine positive control (0.1mL)
Negative Control
n=20 Participants
Normal saline negative control (0.1mL)
Wheal Formation
.85 mm
Interval 0.0 to 3.5
6.68 mm
Interval 4.5 to 11.0
.2 mm
Interval 0.0 to 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 hrs

Wheal formation is defined as a raised, pale, itchy formation (allergic reaction) on the skin's surface. A positive (+) allergic response would be indicated by the NeoMatriXTM Wound Matrix producing a wheal \>3 mm of the positive control (histamine).

Outcome measures

Outcome measures
Measure
NeoMatriX Alone
n=20 Participants
NeoMatriX Wound Matrix Collagen Dressing 8mm disc NeoMatriX Wound MatriX Collagen Dressing: Collagen wound dressing
Positive Control
n=20 Participants
Histamine positive control (0.1mL)
Negative Control
n=20 Participants
Normal saline negative control (0.1mL)
Wheal Formation
0 mm
Interval 0.0 to 0.0
0.1 mm
Interval 0.0 to 1.0
0 mm
Interval 0.0 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 days

Wheal formation is defined as a raised, pale, itchy formation (allergic reaction) on the skin's surface. A positive (+) allergic response would be indicated by the NeoMatriXTM Wound Matrix producing a wheal \>3 mm of the positive control (histamine).

Outcome measures

Outcome measures
Measure
NeoMatriX Alone
n=20 Participants
NeoMatriX Wound Matrix Collagen Dressing 8mm disc NeoMatriX Wound MatriX Collagen Dressing: Collagen wound dressing
Positive Control
n=20 Participants
Histamine positive control (0.1mL)
Negative Control
n=20 Participants
Normal saline negative control (0.1mL)
Wheal Formation
0 mm
Interval 0.0 to 0.0
0 mm
Interval 0.0 to 0.0
0 mm
Interval 0.0 to 0.0

Adverse Events

NeoMatriX Alone

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

Histamine + NeoMatriX

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

Saline + NeoMatriX

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

Dayna Healy

NeXtGen Biologics, Inc

Phone: 352-215-9961

Results disclosure agreements

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