Wound Healing of Incisional Wounds for Bilateral Hernia Repair

Conditions:Hospital, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Age Range:Any - 5
Start Date:October 2009
End Date:April 2013

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The Effect of a Sodium Bicarbonate and Hydrogen Peroxide Gel on Wound Healing of Incisional Wounds for Bilateral Hernia Repair

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.

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.

Inclusion Criteria:

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

Exclusion Criteria:
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Winston-Salem, North Carolina 27157
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Winston-Salem, NC
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