Wound Healing Clinical Trial
Official title:
The Effect of a Sodium Bicarbonate and Hydrogen Peroxide Gel on Wound Healing of Incisional Wounds for Bilateral Hernia Repair
Verified date | January 2017 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research study is to test the safety of an oxygen producing gel (produced
by combining baking soda and hydrogen peroxide) and see what effects (good and bad) it has on
skin incisions in children.
Baking soda and hydrogen peroxide have been approved by the US Food and Drug Administration
(FDA), but have not been approved for use in this manner.
It is hypothesized that a combination of sodium bicarbonate and hydrogen peroxide may enhance
wound healing of incisional wounds for bilateral hernia repair.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 5 Years |
Eligibility |
Inclusion Criteria: - Children with surgery requiring bilateral similar inguinal incisions (i.e. bilateral orchidopexy, bilateral hernia repair). Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound infection, wound dehiscence, allergic reaction to gel components, width, elevation, color, marks and general appearance measured at clinic visits. | days7 and day 14 |
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