CO2Lift and T-Junction Breakdown Rates Evaluation After Breast Reduction Surgery Pilot Trial (NCT07408960) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
CO2Lift and T-Junction Breakdown Rates Evaluation After Breast Reduction Surgery Pilot Trial
10 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment Rate
Timeframe: Through study recruitment completion, an average of 1 year