CO2Lift and T-Junction Breakdown Rates Evaluation After Breast Reduction Surgery Pilot Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carboxygel, Vaseline.
- Who it may be relevant to
- Registry conditions: Wound Breakdown, Breast Reduction, Surgical Wound, Breast Surgery. Basic parameters: 18 years — 85 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Effect of CO2Lift Pro® Carboxy Gel on T-Junction Breakdown Rates After Breast Reduction Surgery: A Feasibility Study
Overview
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.
Interventions
- 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
Primary outcome measures
- Recruitment Rate [Time frame: Through study recruitment completion, an average of 1 year]
- Retention Rate [Time frame: Up to 12 weeks postoperatively.]
- Incidence of Treatment-Related Adverse Events [Time frame: Postoperative days 0-7 days]
- Incidence of Re-operation [Time frame: Up to 12 weeks postoperatively]
Secondary outcome measures (3)
- Incidence of T-Junction Breakdown [Time frame: Up to 12 weeks postoperatively.]
- Time to Wound Healing [Time frame: Up to 12 weeks postoperatively]
- Tissue Oxygen Saturation at the T-Junction [Time frame: Postoperative days 0-6]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07408960 · REB25-0946