NCT07408960

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: Female
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Wound Breakdown
• Breast Reduction
• Surgical Wound
• Breast Surgery

Interventions

Type	Name	Description
OTHER	Carboxygel	The gel will be applied to cover the entire T-junction after breast reduction surgery, once a day for 7 days.
OTHER	Vaseline	Vaseline will be applied to the entire T-junction after breast reduction surgery once a day for 7 days

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2026-02-13
• Last updated: 2026-02-13