CO2Lift and T-Junction Breakdown Rates Evaluation After Breast Reduction Surgery Pilot Trial

Evaluating the Effect of CO2Lift Pro® Carboxy Gel on T-Junction Breakdown Rates After Breast Reduction Surgery: A Feasibility Study

The goal of this pilot study is to determine the feasibility of a larger randomized controlled trial evaluating CO₂Lift® Pro Carboxy Gel to reduce wound breakdown after bilateral breast reduction in adult female patients undergoing elective bilateral breast reduction surgery. The main question it aims to answer is: Is it feasible to recruit, retain, and treat patients while maintaining blinding and monitoring safety?

Exploratory questions include: (1) Does CO₂Lift® reduce the incidence of wound breakdown compared with placebo? (2) Is CO₂Lift® safe and well-tolerated in the postoperative period?

Researchers will compare CO₂Lift® applied to one breast to placebo (Vaseline®) applied to the contralateral breast to see if CO₂Lift® can improve wound healing and tissue oxygenation.

Participants will:

• Undergo bilateral breast reduction surgery.
• Receive CO₂Lift® on one breast and placebo on the other, starting immediately after surgery and daily in clinic from postoperative days 1 to 6.
• Attend weekly postoperative follow-up visits for 12 weeks for wound assessment and monitoring of adverse events.
• Have standardized photographs and near-infrared spectroscopy measurements taken to evaluate tissue oxygenation and healing.

Inclusion Criteria:

• Female patients aged 18 to 85 years
• Undergoing bilateral reduction mammoplasty using an inverted-T (Wise pattern) technique
• American Society of Anesthesiologists (ASA) physical status classification I-III
• Able and willing to provide informed consent
• Willing and able to comply with study procedures and follow-up visits

Exclusion Criteria:

• Prior radiation therapy to either breast
• Prior breast reduction surgery to either breast
• Known allergy or sensitivity to CO2Lift®, Vaseline®, or any of the ingredients
• Pregnant or breastfeeding
• History of immunosuppressive therapy
• History of keloid formation
• Active local or systemic infection at the time of surgery
• Current smoker or history of substance abuse (including alcohol or illicit drugs)
• Use of asymmetrical breast reduction techniques
• Anticipated inability to complete follow-up or loss to follow-up