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

NCT07408960 — Not applicable, Not yet recruiting, 10 participants, University of Calgary

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Evaluating the Effect of CO2Lift Pro® Carboxy Gel on T-Junction Breakdown Rates After Breast Reduction Surgery: A Feasibility Study

Registry	NCT07408960, acronym CO2-BREAST
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, supportive care
Enrollment	10 (Estimated)
Sponsor	University of Calgary (Other)
Conditions	Wound Breakdown, Breast Reduction, Surgical Wound, Breast Surgery
Interventions	Carboxygel, Vaseline (Other)
Dates	start 2026-04-01 (estimated), primary completion 2027-12-31 (estimated), completion 2027-12-31 (estimated), first posted 2026-02-13, last updated 2026-02-13

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Treated breast	Experimental	Other: Carboxygel	CO2 Lift Pro® Carboxygel treated breast
Placebo breast	Placebo comparator	Other: Vaseline	Vaseline® control breast

Carboxygel (Other), also known as CO2 Lift Pro: The gel will be applied to cover the entire T-junction after breast reduction surgery, once a day for 7 days.
Vaseline (Other), also known as Petroleum jelly, Petrolatum: Vaseline will be applied to the entire T-junction after breast reduction surgery once a day for 7 days

+Outcome measures

Primary outcomes

Recruitment Rate [Through study recruitment completion, an average of 1 year]: Number of participants enrolled per month during the recruitment period.
Retention Rate [Up to 12 weeks postoperatively.]: Proportion of enrolled participants completing the 12-week follow-up period.
Incidence of Treatment-Related Adverse Events [Postoperative days 0-7 days]: Number of participants experiencing any treatment-related adverse event, including local skin reactions.
Incidence of Re-operation [Up to 12 weeks postoperatively]: Number of participants requiring surgical re-intervention related to wound complications.

Secondary outcomes

Incidence of T-Junction Breakdown [Up to 12 weeks postoperatively.]: Presence of wound dehiscence at the T-junction, assessed by blinded adjudication (Proportion of breasts with breakdown (%)).
Time to Wound Healing [Up to 12 weeks postoperatively]: Number of days from surgery to complete epithelialization of the T-junction.
Tissue Oxygen Saturation at the T-Junction [Postoperative days 0-6]: Change in tissue oxygen saturation (StO₂) measured using near-infrared spectroscopy before and after treatment application.

+Eligibility

Sex: Female, ages: 18 Years to 85 Years

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