(CR-039) The effect of Continuous Diffusion of Oxygen on breast tissue – Updated results from a Pilot Randomized Clinical Trial

Alejandro Zulbaran-Rojas, MD – Baylor College of Medicine; Rasha Bara, BS – Baylor College of Medicine; Miguel Bargas-Ochoa, MD – Baylor College of Medicine; Myeounggon Lee, PhD – Baylor College of Medicine; Sebastian Winocour, MD – Michael E. DeBakey Department of Surgery – Baylor College of Medicine; Alastair Thompson, MD – Michael E. DeBakey Department of Surgery – Baylor College of Medicine; Bijan Najafi, PhD, MSc – Baylor College of Medicine

Introduction: Bilateral Reduction Mammoplasty (BRM)^{1, 2} requires the removal of breast tissue in women with macromastia. This procedure often requires an upside down “T”, high-tension incision (T-Junction)³ with known successful wound healing rates. However, cases with high tissue removal ( >750 gr) are susceptible to wound dehiscence at 1-month post-operative follow-up mostly due to low perfusion to the “T” junction⁴. Continuous Diffusion of Oxygen (CDO) has shown to improve surgically closed wound outcomes in patients undergoing lower neck surgery.⁵ This study examines the CDO effectiveness to improve tissue oxygenation and reduce wound dehiscence at the T-junction in women undergoing BRM.

Methods: A 4-week pilot randomized controlled trial in women undergoing BRM was conducted. The groups were internally randomized (left or right breast) to either receive standard of care (SOC) at the T-junction, SOC + CDO covered by a silicon sheet (sCDO), or CDO directly to the T-Junction skin (dCDO) for a  4-week duration. The primary outcome included T-junction wound dehiscence compared between the breast groups using Chi-square test. The secondary outcome included T-junction tissue saturation of oxygen (SatO₂) assessed with Near-Infrared Spectroscopy (NIRS) and further analyzed with generalized linear model normalized to percentage change. 

Results: Forty breasts (SOC, n=10; sCDO, n=10; dCDO, n=10) in twenty women (age= 35 ± 10 years, BMI= 34 ± 5 kg/m2) were included. The total breast tissue removal was 0.96±0.38 kg (p=0.75). At 4-week follow-up, breasts under sCDO showed a lower trend for T-Junction wound dehiscence compared to breasts undergoing SOC (0% vs 15%, p=0.19). In addition, breasts under sCDO showed a higher T-Junction SatO₂ compared to breasts undergoing SOC (p=0.006, d=1.2) and dCDO (p< 0.001, d=1.6). Breasts under SOC and cDCO showed a significant decline in SatO₂ from baseline to 4-week (p< 0.001, d=1.3; p< 0.001, d=2.7, respectively). However, breasts under sCDO did not show decline in SatO₂ (p >0.05).



Discussion: CDO with an adjunctive silicon sheet resulted in significant increase of T-Junction SatO₂ at 4 weeks. This modality showed a lesser wound dehiscence trend; however, it was not statistically significant. These findings should be explored in a higher sample size.