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NCT Number: NCT07408960

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

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.

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Key information

Conditions

Wound Breakdown Breast Reduction Breast Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Surgical Wound Dehiscence Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carboxygel

Other

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

Vaseline

Other

Vaseline will be applied to the entire T-junction after breast reduction surgery once a day for 7 days

Other names: Petroleum jelly, Petrolatum

Primary outcomes

  1. Recruitment Rate

    Time frame: Through study recruitment completion, an average of 1 year

    Number of participants enrolled per month during the recruitment period.

  2. Retention Rate

    Time frame: Up to 12 weeks postoperatively.

    Proportion of enrolled participants completing the 12-week follow-up period.

  3. Incidence of Treatment-Related Adverse Events

    Time frame: Postoperative days 0-7 days

    Number of participants experiencing any treatment-related adverse event, including local skin reactions.

  4. Incidence of Re-operation

    Time frame: Up to 12 weeks postoperatively

    Number of participants requiring surgical re-intervention related to wound complications.

Secondary outcomes

  1. Incidence of T-Junction Breakdown

    Time frame: Up to 12 weeks postoperatively.

    Presence of wound dehiscence at the T-junction, assessed by blinded adjudication (Proportion of breasts with breakdown (%)).

  2. Time to Wound Healing

    Time frame: Up to 12 weeks postoperatively

    Number of days from surgery to complete epithelialization of the T-junction.

  3. Tissue Oxygen Saturation at the T-Junction

    Time frame: Postoperative days 0-6

    Change in tissue oxygen saturation (StO₂) measured using near-infrared spectroscopy before and after treatment application.

Study contacts

Contact information is provided by the study sponsor or research team.

Merry Faye Graff, MSc

CONTACT

[email protected]

5876642280

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Acronym: CO2-BREAST

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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