Optimizing Tissue Oxygenation in Reduction Mammoplasty: The Role of Continuous Diffusion of Oxygen: A Feasibility Pilot Randomized Controlled Trial.

INTRODUCTION: Bilateral reduction mammoplasty (BRM) aims to alleviate macromastia-related symptoms in women. This procedure involves a T-Junction suture at the medial inframammary fold that encompasses 12%-39% of wound breakdowns mainly due to reduced perfusion. Continuous diffusion of oxygen (CDO) may enhance breast tissue oxygenation to prevent such complication. We explored the feasibility of this therapy. METHODS: A 4-wk feasibility-pilot randomized controlled trial of women undergoing BRM was conducted. By internal randomization (left/right side), participants received standard of care (SOC) in one breast using topical skin adhesive, while their other breast received SOC + CDO at the T-junction covered by a silicon sheet (sCDO), or CDO directly to the T-Junction skin (dCDO). Feasibility outcomes included protocol delivery, outcome measurement, device-related adverse events, and device acceptability. Exploratory outcomes were T-Junction SatO2 and deoxyhemoglobin assessed with near-infrared spectroscopy and wound dehiscence. RESULTS: Sixteen participants (age = 33 ± 8 y; body mass index = 34.34 ± 5.85 kg/m2) were recruited, conforming n = 32 breasts (SOC, n = 16; dCDO, n = 10, sCDO, n = 6). At 4 wk, protocol delivery was 93.7%, outcome measuring 100%, and device-related adverse events 0%. Device acceptability showed an 85.4% strong agreement for attitude toward use, 78.2% perceived ease of use, and 77.7% perceived usefulness. Breasts undergoing sCDO showed higher SatO2 (P < 0.001), whereas lower deoxyhemoglobin (P < 0.001) compared to all other breast groups. However, wound dehiscence was not different between groups (P = 0.66). CONCLUSIONS: Self-applied CDO to the T-Junction is feasible, safe, and acceptable, in patients undergoing BRM. In a proper wound environment, CDO may enhance breast tissue oxygenation. However, it is unclear whether CDO leads to decreased wound dehiscence. This study showed reproducibility for larger randomized trials.