The Management of Critically Colonized and Locally Infected Leg Ulcers with an Acid-Oxidizing Solution: A Pilot Study

Abstract

Objective: Critical colonization or local infection is very common in chronic wounds, but clinically problematic. Because therapeutic options for these conditions are limited in number and efficacy, the study authors tested a new acid-oxidizing solution (AOS [Nexodyn]; APR Applied Pharma Research S.A., Balerna, Switzerland) to determine its ancillary antimicrobial properties and potential support for wound healing.

Design and setting: This open-label clinical case series was conducted with a prospective, single-arm design at the Federal County Hospital in Bregenz, Austria.

Patients: In the study, 30 patients with critically colonized or locally infected chronic leg ulcers of any origin were included.

Interventions: The AOS was applied on each leg ulcer at every dressing change for 35 days.

Main outcome measures: The tolerability and performance of the AOS were assessed by evaluating the ulcer characteristics and comparing them with those at baseline. The clinical course of wounds was analyzed using standard measures for bioburden, local infection, pain, pH, and wound healing.

Main results: Application of the solution was well tolerated, and no adverse events were recorded. In all patients, local infection was overcome, and wound bed pH and wound area decreased significantly. In addition, patient pain levels decreased to a level where interventions were not required after study day 7. In 37% of all patients, a complete resolution of chronic ulcers was achieved by the end of the study period.

Conclusion: According to these results, the AOS seems to be a valid and highly tolerable treatment to support wound healing in locally infected ulcers. Nevertheless, larger controlled cohort studies are needed to substantiate these findings.

Figure 1.

COURSE OF HEALING IN 2 REPRESENTATIVE STUDY PATIENTS RECEIVING TREATMENT INCLUDING THE AOS

Figure 2.

CHANGE IN LOCAL INFECTION SCORE Data are presented in box plots where the lower and upper borders of the box represent lower and upper quartiles of the data distribution, respectively. Diamonds represent mean values, and the bars in the box, the median of the data. Over time, the local infection score decreased steadily and significantly (P < .0001, Friedman test). Between day 21 (visit 4) and 35 (visit 6), chronic ulcers had healed in 37% of patients.

Figure 3.

CHANGE IN BIOBURDEN Data are presented by box plots where the lower and upper borders of the box represent lower and upper quartiles of the data distribution, respectively. Diamonds represent mean values, and the bars in the box, the median of the data. Over time, the percentage of bioburden covering the wound decreased steadily and significantly (P = .0009, Friedman test).

Figure 4.

CHANGE IN PH VALUE Data are presented by box plots where the lower and upper borders of the box represent lower and upper quartiles of the data distribution, respectively. Diamonds represent mean values, and the bars in the box, the median of the data. Over time, the pH values measured on the wound beds decreased steadily and significantly (P < .0001, Friedman test).

Figure 5.

CHANGE IN WOUND SIZE Data are presented by box plots where the lower and upper borders of the box represent lower and upper quartiles of the data distribution, respectively. Diamonds represent mean values, and the bars in the box, the median of the data. Over time, wound area decreased steadily and significantly (P < .0001, Friedman test).

Figure 6.

CHANGE IN WOUND-ASSOCIATED PAIN Data are presented by box plots where the lower and upper borders of the box represent lower and upper quartiles of the data distribution, respectively. Diamonds represent mean values, and the bars in the box, the median of the data. Over time, the wound-associated pain decreased steeply and significantly (P < .0001, Friedman test).