Wound Healing of Incisional Wounds for Bilateral Hernia Repair

NCT01008111 | Withdrawn Phase 1

• 1 other identifier: IRB00009521
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

regeneration; tissue survival; biological processes; connective tissue; tissue

Outcome Measures

Primary Outcomes (1)

• Wound infection, wound dehiscence, allergic reaction to gel components, width, elevation, color, marks and general appearance measured at clinic visits.

  days7 and day 14

Study Arms (2)

Hydrogen Peroxide Oxygen producing gel

ACTIVE COMPARATOR

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

Dermabond-Placebo Comparator

PLACEBO COMPARATOR

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: Dermabond

Interventions

Dermabond DRUG

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.

Dermabond-Placebo Comparator

Hydrogen Peroxide Oxygen producing gel DRUG

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.

Hydrogen Peroxide Oxygen producing gel

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with surgery requiring bilateral similar inguinal incisions (i.e. bilateral orchidopexy, bilateral hernia repair).

You may not qualify if:

• None.

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

octyl 2-cyanoacrylate

Study Officials

• Steve Hodges, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2009
• First Posted: November 5, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 6, 2017

Record last verified: 2017-01

Locations

US (1)