NeoMatriX Wound Matrix Collagen Dressing Skin Prick Test

Study Overview
=================
Brief 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.

Official Title
-----------------
Skin Prick Test in Healthy Volunteers of Any Sex, to Investigate the Potential Allergy to NeoMatriXTM Wound Matrix

Conditions
-----------------
Allergy Skin, Allergy, Dermatitis, Allergic Contact

Intervention / Treatment
-----------------
* Device: NeoMatriX Wound MatriX Collagen Dressing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers aged at least 18 years. Completed written informed consent and receive a copy of their executed ICF. Volunteers must be capable of understanding and following directions in English. Exclusion Criteria: Pregnancy or lactation; Inadequate or non-existent contraception (women of child bearing potential only); A current skin disease; Heavy alcohol consumption; Current use or history of repeated use of recreational drugs; Recent illness prior to test; Significant past medical history of diseases to potentially effect study results; Current treatment of allergy; A history of multiple drug hypersensitivity; Concurrent medication likely to affect the response to the test articles or confuse the results of the study; Known sensitivity to the test articles; Participation in a repeat insult patch test (RIPT), skin prick test (SPT) or follow-up work within the last month; Sensitization or questionable sensitization in a skin test; Recent immunization.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NeoMatriX and Two Comparators<br>NeoMatriX Wound Matrix Collagen Dressing 8mm disc Histamine positive control (0.1mL) Normal saline negative control (0.1mL) | Device: NeoMatriX Wound MatriX Collagen Dressing<br>* Collagen wound dressing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wheal Formation | 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). | 15 minutes |