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Wound Healing of Incisional Wounds for Bilateral Hernia Repair

Primary Purpose

Wound Healing

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dermabond
Hydrogen Peroxide Oxygen producing gel
Sponsored by
Wake Forest University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Wound Healing focused on measuring regeneration, tissue survival, biological processes, connective tissue, tissue

Eligibility Criteria

undefined - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

None.

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hydrogen Peroxide Oxygen producing gel

Dermabond-Placebo Comparator

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 4, 2009
Last Updated
November 2, 2017
Sponsor
Wake Forest University
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1. Study Identification

Unique Protocol Identification Number
NCT01008111
Brief Title
Wound Healing of Incisional Wounds for Bilateral Hernia Repair
Official Title
The Effect of a Sodium Bicarbonate and Hydrogen Peroxide Gel on Wound Healing of Incisional Wounds for Bilateral Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Withdrawn
Why Stopped
study never initiated
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Wound healing is a complex regeneration process, which is characterized by degradation and re-assembly of connective tissue and epidermal layer. The pH value within the wound-milieu influences indirectly and directly all biochemical reactions taking place in this process of healing. Interestingly, it is so far a neglected parameter for the overall outcome. For more than three decades the common assumption amongst physicians was that a low pH value, such as it is found on normal skin, is favorable for wound healing. However, investigations have shown that in fact some healing processes such as the take-rate of skin-grafts require an alkaline milieu. The matter is thus much more complicated than it was assumed. One review drew the conclusion that wound pH is potent influential factor for the healing process and that different pH ranges are required for certain distinct phases of wound healing. Further systematic data needs to be collected for a better understanding of the pH requirements under specific circumstances. This is important as it will help to develop new pH targeted therapeutic strategies. Such shifts in the pH can be accomplished through the use of sodium biocarbonate (baking soda) Another common agent used in wound treatments is hydrogen peroxide. It has been hypothesized that hydrogen peroxide would accelerate reepithelization and/or have a positive effect on infection. However, the results of using hydrogen peroxide alone do not appear to support this hypothesis. (Table 1) However, one report using a combination of baking soda and hydrogen peroxide on post-surgical wound healing showed a significant increase in wound healing from oral surgery. A randomized, double-blind crossover study involving 25 patients requiring bilateral maxillary gingival flap surgery was completed. The effects of twice daily brushing with a baking soda-hydrogen peroxide dentifrice or a placebo dentifrice were observed over a 28-day post-surgical period. At days 7 and 14, soft tissue appearance/wound healing (STA) was assessed based on color and edema,. Post-surgical wound healing was statistically significantly improved at day 7 with the trend continuing to day 14 when sodium bicarbonate-hydrogen peroxide was used as compared to a control. Such materials were shown to be a possibly effective aid in the early phase of healing following gingival flap surgery. It has been determined that this combination of products may increase oxygen content to the wound sites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing
Keywords
regeneration, tissue survival, biological processes, connective tissue, tissue

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hydrogen Peroxide Oxygen producing gel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Dermabond-Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dermabond
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Hydrogen Peroxide Oxygen producing gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound infection, wound dehiscence, allergic reaction to gel components, width, elevation, color, marks and general appearance measured at clinic visits.
Time Frame
days7 and day 14

10. Eligibility

Sex
All
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with surgery requiring bilateral similar inguinal incisions (i.e. bilateral orchidopexy, bilateral hernia repair). Exclusion Criteria: None.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Hodges, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Wound Healing of Incisional Wounds for Bilateral Hernia Repair

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