MedTrace Logo

Wound Healing of Incisional Wounds for Bilateral Hernia Repair

NCT01008111 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-11-06

No results posted yet for this study

Summary

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.

Conditions

  • Wound Healing

Interventions

DRUG

Dermabond

On Day 0 patients will undergo bilateral inguinal surgery. One side will be dressed using a standard surgical dressing, while the other will use a combination hydrogen peroxide/baking soda gel placed over the wound and covered with a sealing dressing. The study team will determine which side gets assigned standard surgical dressing by the flip of a coin.

DRUG

Hydrogen Peroxide Oxygen producing gel

On Day 0 patients will undergo bilateral inguinal surgery. One side will be dressed using a standard surgical dressing, while the other will use a combination hydrogen peroxide/baking soda gel placed over the wound and covered with a sealing dressing. The study team will determine which side gets assigned standard surgical dressing by the flip of a coin.

Sponsors & Collaborators

  • Wake Forest University

    lead OTHER

Principal Investigators

  • Steve Hodges, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01008111 on ClinicalTrials.gov