CO2Lift and T-Junction Breakdown Rates Evaluation After Breast Reduction Surgery Pilot Trial (CO2-BREAST)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Surgery; Surgical Wound; Wound Breakdown; Breast Reduction
• Intervention / Treatment: Other: Carboxygel; Other: Vaseline

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merry Faye Graff, MSc; Phone Number: 5876642280; Email: merryfaye.graff1@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated breast; CO2 Lift Pro® Carboxygel treated breast	Other: Carboxygel; The gel will be applied to cover the entire T-junction after breast reduction surgery, once a day for 7 days.; Other Names: CO2 Lift Pro
Placebo Comparator: Placebo breast; Vaseline® control breast	Other: Vaseline; Vaseline will be applied to the entire T-junction after breast reduction surgery once a day for 7 days; Other Names: Petrolatum; Petroleum jelly

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Surgical Wound; Surgical Wound Dehiscence; Organic Chemicals; Hydrocarbons; Petrolatum
• Other Study ID Numbers: REB25-0946

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data will not be shared outside the study team due to the small sample size and the potential risk of participant re-identification. Aggregate study results will be reported in publications and presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No