Wound BreakdownCO2-BREASTNCT07408960
CO2Lift and T-Junction Breakdown Rates Evaluation After Breast Reduction Surgery Pilot Trial
A study testing Carboxygel and Vaseline in people with Wound Breakdown and Breast Reduction, run by University of Calgary.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Wound Breakdown, Breast Reduction, Surgical Wound
- What is being tested?
- Carboxygel and Vaseline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read more
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
- Being tested
- Carboxygel, Vaseline
- Medical subject headings
- Surgical Wound Dehiscence, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboxygelOther
Also called CO2 Lift Pro
The gel will be applied to cover the entire T-junction after breast reduction surgery, once a day for 7 days.
VaselineOther
Also called Petroleum jelly, Petrolatum
Vaseline will be applied to the entire T-junction after breast reduction surgery once a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Treated breast | Experimental | CO2 Lift Pro® Carboxygel treated breast Receives: Other: Carboxygel |
| Placebo breast | Placebo comparator | Vaseline® control breast Receives: Other: Vaseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Number of participants enrolled per month during the recruitment period.
Measured: Through study recruitment completion, an average of 1 year
Retention Rate
Proportion of enrolled participants completing the 12-week follow-up period.
Measured: Up to 12 weeks postoperatively.
Incidence of Treatment-Related Adverse Events
Number of participants experiencing any treatment-related adverse event, including local skin reactions.
Measured: Postoperative days 0-7 days
Incidence of Re-operation
Number of participants requiring surgical re-intervention related to wound complications.
Measured: Up to 12 weeks postoperatively
Secondary outcomes (3)
Incidence of T-Junction Breakdown
Presence of wound dehiscence at the T-junction, assessed by blinded adjudication (Proportion of breasts with breakdown (%)).
Measured: Up to 12 weeks postoperatively.
Time to Wound Healing
Number of days from surgery to complete epithelialization of the T-junction.
Measured: 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.
Measured: Postoperative days 0-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound BreakdownStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Yeung, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408960
- Sponsor's protocol ID
- REB25-0946
- Acronym
- CO2-BREAST
- Status last verified
- Feb 2026
- First submitted
- 28 Nov 2025
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of CO2Lift Pro® Carboxy Gel on T-Junction Breakdown Rates After Breast Reduction Surgery: A Feasibility Study
- ClinicalTrials.gov ID
- NCT07408960
- Acronym / sponsor ID
- CO2-BREAST / REB25-0946
- Conditions
- Wound Breakdown, Breast Reduction, Surgical Wound, Breast Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treated breast | Experimental | Other: CarboxygelCO2 Lift Pro® Carboxygel treated breast |
| Placebo breast | Placebo comparator | Other: VaselineVaseline® control breast |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboxygelAlso: CO2 Lift ProThe gel will be applied to cover the entire T-junction after breast reduction surgery, once a day for 7 days. | Other | Treated breast |
| VaselineAlso: Petroleum jelly, PetrolatumVaseline will be applied to the entire T-junction after breast reduction surgery once a day for 7 days | Other | Placebo breast |
Primary outcome
Recruitment Rate
Time frame: Through study recruitment completion, an average of 1 year
Number of participants enrolled per month during the recruitment period.
Retention Rate
Time frame: Up to 12 weeks postoperatively.
Proportion of enrolled participants completing the 12-week follow-up period.
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.
Incidence of Re-operation
Time frame: Up to 12 weeks postoperatively
Number of participants requiring surgical re-intervention related to wound complications.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Carboxygel and Vaseline in people with Wound Breakdown and Breast Reduction, run by University of Calgary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merry Faye Graff, MSc (5876642280, merryfaye.graff1@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: Through study recruitment completion, an average of 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.