NOT YET RECRUITING
NCT07408960
CO2Lift and T-Junction Breakdown Rates Evaluation After Breast Reduction Surgery Pilot Trial
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.
Gender: FEMALE
Ages: 18 Years - 85 Years
Wound Breakdown
Breast Reduction
Surgical Wound
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