Clinical Trial

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

Study acronym: CO2-BREAST
Not Yet Recruiting
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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.
Trial Details
NCT Number NCT07408960
Lead Sponsor University of Calgary
Conditions Wound Breakdown, Breast Reduction, Surgical Wound, Breast Surgery
Enrollment 10 participants
Start Date 2026-04-01
Primary Completion 2027-12-31 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-13