Evaluation of Oxygen Delivery with Transcu O2 on Surgically Closed Wounds (H-41361)

Lower extremity surgical interventions such as minor amputations (e.g. toe amputation) and reconstructive foot surgery (e.g. surgical offloading to fix chronic deformities) have become an important component of limb salvage efforts to prevent major amputations (i.e. above ankle) and preserve maximum function in patients with diabetes and loss of protective sensation. Wounds post-lower extremity intervention are mainly closed surgically. However, surgical wound complications such as infection, dehiscence, necrotic tissue, surgical revision, and poor cosmesis are unfortunately highly prevalent in patients undergoing surgical interventions. The study aims to assess the effectiveness of the TransCu O2 oxygen delivery system in reducing the likelihood of wound complications after surgical closure. It also intends to measure changes in skin perfusion in patients treated with TransCu O2 oxygen delivery system, and to evaluate changes in quality of life, anxiety during dressing change, and psychosocial parameters in patients with a surgical wound.

Inclusion Criteria:
Presence of a wound due to surgical closure
18-85 years of age

Exclusion Criteria:
Bilateral major amputation
Gangrene or osteomyelitis