Effectiveness of Continuous Diffusion of Oxygen Adjunct Therapy to Improve Success Rate of Lower Extremity Surgically Closed Wounds – A Randomized Controlled Trial Study

Lower-extremity surgically closed wounds in patients with diabetes could be severely affected by poor tissue oxygenation (1-2). Adverse events (AE) such as necrosis, dehiscence, or re-operation are among the most common complications (3). In this study, we tested a continuous diffusion of oxygen (CDO) novel dressing* as supplement to reduce the likelihood of AE.

Nineteen diabetic patients who underwent minor amputation requiring surgical wound closure were randomized to either control (CG: n=7) or intervention (IG: n=12) groups. The IG received CDO using a portable O2 delivery system* for a 4-week period or until successfully wound closure. The CG group received standard of care dressing for the same period. Primary outcomes were incident of AE and changes in wound length at 4-week. For those successfully healed wounds, percentage of wound reduction (%WR) was considered as 100%. For those with wound dehiscence, %WR was noted as 0%. For other cases, %WR was objectively measured using an imaging system†. General linear model was used for analysis. The study was registered in Clinicaltrials.gov-Identifier: NCT03960463.

Three cases (43%) among CG had AE which required re-operation. Two IG cases (16.6%) reported saturated dressing and excessive bleeding which were excluded before completing the study. This led to modification in dressing to accommodate absorbing excessive saturation. No AE was reported for IG after dressing modification. At 4-week, the incision length reduction was 70% higher in IG compared to control. This trend did not achieve statistical significant level in our sample (p=0.059).

To our knowledge this is the first study reporting potential effectiveness of CDO to improve surgically closed wound outcomes. The results, while preliminary, support proof of concept feasibility, acceptability and noticeable trend in favor of CDO to accelerate healing in surgical closed wounds and reduce the likelihood of AE.

Trademarked Items (if applicable): * TransCu O2®, EO2 Concepts, SA, TX, USA
† Snapshot NIR, KENT Imaging Inc., Calgary, AB, CAN

References (if applicable): 1. Chandan K. Sen, et al. Wound healing essentials: let there be oxygen. Wound Repair Regan. 2009; 17(1): 1-18.
2. Brian Wernick, et al. Impaired Wound Healing. StatPearls Publishing; 2020.
3. Zegers, M. The incidence, root-causes, and outcomes of adverse events in surgical units: implication for potential prevention strategies. Patient Sat Surg. 2011;5:13.