About this 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Carboxygel
- Vaseline