Trials / Completed
CompletedNCT03522675
NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test
Skin Prick Test in Healthy Volunteers of Any Sex, to Investigate the Potential Allergy to NeoMatriXTM Wound Matrix
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- NeXtGen Biologics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study is to investigate the potential of NeoMatriXTM Wound Matrix to cause an allergic response to healthy volunteers using a skin prick test.
Detailed description
Using a minimally invasive skin prick test, the test material, positive control, and negative control are applied to the forearm using a prick test. The test area is observed after 15 minutes, 6 hours, and again at 1-2 days after the initial prick test. The skin will be examined for a reaction such as a wheal and/or a flare, a flare alone is not clinically significant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NeoMatriX Wound MatriX Collagen Dressing | Collagen wound dressing |
Timeline
- Start date
- 2018-04-11
- Primary completion
- 2018-04-26
- Completion
- 2018-04-28
- First posted
- 2018-05-11
- Last updated
- 2019-05-31
- Results posted
- 2019-05-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03522675. Inclusion in this directory is not an endorsement.