Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01008111
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Withdrawn
Phase Phase 1
Start date October 2009
Completion date April 2013

See also
  Status Clinical Trial Phase
Completed NCT05045183 - A Study to Assess Wound Healing Efficacies of Different Clean, Treat, and Protect Wound Care Regimens Compared to Standard of Care and Untreated N/A
Enrolling by invitation NCT04613336 - Efficacy of Topical Heparin Spray on Donor Site Wound Healing Time Compared to Conventional Dressing Among Patients Undergoing Split Thickness Skin Grafting
Recruiting NCT02241811 - Wound Treatment With 3% Sodium Pentaborate Pentahydrate Phase 1
Completed NCT02797899 - Effect of PRF Palatal Bandage on Pain Scores and Wound Healing After Free Gingival Graft N/A
Completed NCT01227759 - Tyrosur® Gel-Investigation on Wound Healing Efficacy Phase 2
Completed NCT01061502 - Efficacy Study of a Bioelectric Dressing to Treat Skin Graft Donor Site Wounds Phase 1/Phase 2
Completed NCT00736593 - A Study Evaluating Nexagon™ in the Treatment of Skin Wounds. Phase 1
Completed NCT00977951 - Genomic Changes Associated With the Use of Intradermal Avotermin (Juvista) in Small Wounds in Healthy Male Subjects Phase 1/Phase 2
Not yet recruiting NCT03872544 - Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Enrolling by invitation NCT03880188 - Long Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds
Recruiting NCT05191082 - Manufacturing, Characterization and Evaluation of the Effect of Silk Fibroin Membranes, Loaded or Not With Neurotensins on Open Wounds in the Palate N/A
Enrolling by invitation NCT05942235 - The Use of Microlearning in Nursing Education
Completed NCT03433820 - Wound Healing in Healthy Volunteers N/A
Withdrawn NCT02383992 - Postoperative Care of Sutured Wounds N/A
Recruiting NCT02034539 - VADOplex Critical Limb Ischemia Study Phase 2/Phase 3
Recruiting NCT01680042 - Clinical Effect of Phenytoin Mucoadhesive Paste on Wound Healing After Oral Biopsy Phase 1
Completed NCT01734317 - An Open Single-centre Investigation Evaluating Efficacy in Second Degree Partial Thickness Burns Using a Silicone Contact Layer Containing Silver. N/A
Completed NCT01115218 - The Influence of Anterior Chamber Fluid Mediators on the Success Rate of Trabeculectomy
Completed NCT00984503 - Investigation of the Accelerated Healing and Anti-scarring Potential of Avotermin (Juvista) in Split Skin Graft Donor Sites Phase 2
Terminated NCT00177060 - Topical Hydromorphone for Wound Healing Phase 1/Phase 2