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

Alejandro Zulbaran-Rojas; Rasha O Bara; Myeounggon Lee; Areli Flores-Camargo; Ramkinker Mishra; Sebastian Winocour; Alastair Thompson; Bijan Najafi

doi:10.1016/j.jss.2023.07.035

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

J Surg Res. 2023 Dec:292:113-122. doi: 10.1016/j.jss.2023.07.035. Epub 2023 Aug 21.

Authors

Alejandro Zulbaran-Rojas¹, Rasha O Bara¹, Myeounggon Lee¹, Areli Flores-Camargo¹, Ramkinker Mishra¹, Sebastian Winocour², Alastair Thompson³, Bijan Najafi⁴

Affiliations

¹ Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
² Division of Adult Plastic Surgery, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
³ Section of Breast Surgery, Division of Surgical Oncology, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas.
⁴ Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, Texas. Electronic address: bijan.najafi@bcm.edu.

PMID: 37611440
DOI: 10.1016/j.jss.2023.07.035

Abstract

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.

Keywords: Bilateral reduction mammoplasty; Continuous diffusion of oxygen; Deoxyhemoglobin; T-junction; Tissue oxygen saturation; Wound breakdown.