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

NCT07408960 | Not Yet Recruiting DMC

• 1 other identifier: REB25-0946
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Wound Breakdown; Breast Reduction; Surgical Wound; Breast Surgery

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Incidence of T-Junction Breakdown

  Up to 12 weeks postoperatively.

• Time to Wound Healing

  Up to 12 weeks postoperatively

• Tissue Oxygen Saturation at the T-Junction

  Postoperative days 0-6

Study Arms (2)

Treated breast

EXPERIMENTAL

CO2 Lift Pro® Carboxygel treated breast

Other: Carboxygel

Placebo breast

PLACEBO COMPARATOR

Vaseline® control breast

Other: Vaseline

Interventions

Carboxygel OTHER

The gel will be applied to cover the entire T-junction after breast reduction surgery, once a day for 7 days.

Also known as: CO2 Lift Pro

Treated breast

Vaseline OTHER

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

Also known as: Petroleum jelly, Petrolatum

Placebo breast

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

MeSH Terms

Conditions

Surgical Wound Dehiscence; Surgical Wound

Interventions

Petrolatum

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Central Study Contacts

Merry Faye Graff, MSc

CONTACT

5876642280; merryfaye.graff1@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized, placebo-controlled, within-subject (split-breast) interventional feasibility pilot study. All participants undergo bilateral breast reduction, with one breast randomized to receive CO2Lift® and the contralateral breast receiving a placebo. Randomization occurs at the breast level, and participants serve as their own control.

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: February 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share