(CR-028) The Effect of Regenerative Debridement Technology (RDT*) on Wound Bed Preparation with Respect to pH Modulation and Normalization

Introduction:
Debridement plays a critical role in wound bed preparation and management. In addition to removing necrotic tissue, debridement can eliminate bacteria that are frequently harbored within the tissue.¹ It is well documented that the alkaline pH of the wound bed is one of the factors that inhibit wound healing.^2,3 The purpose of this study is to examine the effect of RDT, a non-biologic, wound bed debridement agent, on pH in the wound bed of chronic DFUs and VLUs.

Methods:
Twenty-eight patients (13 DFUs and 15 VLUs) were evaluated in conjunction with sharp debridement. A pH meter was used to record wound bed pH data, pre sharp debridement, post sharp debridement, immediately post RDT application, 24 hours, 1 week, and 2 weeks post initial, singular, RDT application. After sharp debridement, RDT was applied to the wound bed for 45 seconds then rinsed with normal sterile saline. The standard of care dressings were used for both wound etiologies. Additionally, DFU continued their offloading protocols and VLUs continued their compression regimens.

Results:
DFU (n=13):

1. Initial, median pH of the wound bed: 8.50 (range, 8.24 – 9.14)

2. Post sharp debridement, median pH: 8.56 (range, 8.20 – 9.12)

3. Post RDT debridement, median pH: 5.36 (range, 5.11 – 5.73)

4. 24-hour post RDT debridement, median pH: 5.45 (range, 5.14 – 5.89)

5. 1-week post RDT debridement, median pH 5.64 (range, 5.20 – 5.95)

6. 2-week post RDT debridement, median pH 8.10 (range, 7.69 – 8.66)





VLU (n=15):

1. Initial, median pH of the wound bed: 8.92 (range, 8.42 – 9.40)

2. Post sharp debridement, median pH: 8.54 (range, 8.35 – 9.34)

3. Post RDT debridement, median pH: 5.41 (range, 5.14 – 5.76)

4. 24-hour post RDT debridement, median pH: 5.49 (range, 5.24 – 5.87)

5. 1-week post RDT debridement, median pH 5.57 (range, 5.30 – 5.89)

6. 2-week post RDT debridement, median pH 8.84 (range, 7.34 – 9.12)

Discussion:
RDT demonstrates the ability to return the chronic, alkaline wound bed to normal physiologic dermal pH for at least a week’s duration. This initial study demonstrates the positive effect of RDT on the pH of the wound bed from initial application as a debridement agent for a two-week period. RDT functioning as a primary or adjunctive debridement method may allow for an improved pathway in chronic wound healing by modulating and normalizing the wound bed pH environment. Further investigations are warranted to study this non-biologic breakthrough technology.