An interventional study of Carboxygel and Vaseline in Wound Breakdown, Breast Reduction and Surgical Wound, sponsored by University of Calgary. Not yet recruiting. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by University of Calgary · Not applicable, Interventional, and Supportive care
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:
48 studies on the registry are indexed under Surgical Wound Dehiscence; 14 are open to participants now.
This study's planned enrollment of 10 is below the median of 78 across 37 interventional studies indexed under Surgical Wound Dehiscence.
Browse Surgical Wound Dehiscence studies →University of Calgary is the lead sponsor of 703 studies on the registry; 196 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 2 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CO2 Lift Pro® Carboxygel treated breast
Other: Carboxygel
Vaseline® control breast
Other: Vaseline
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
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
Recruitment Rate
Number of participants enrolled per month during the recruitment period.
Time frame: Through study recruitment completion, an average of 1 year
Retention Rate
Proportion of enrolled participants completing the 12-week follow-up period.
Time frame: Up to 12 weeks postoperatively.
Incidence of Treatment-Related Adverse Events
Number of participants experiencing any treatment-related adverse event, including local skin reactions.
Time frame: Postoperative days 0-7 days
Incidence of Re-operation
Number of participants requiring surgical re-intervention related to wound complications.
Time frame: Up to 12 weeks postoperatively
Incidence of T-Junction Breakdown
Presence of wound dehiscence at the T-junction, assessed by blinded adjudication (Proportion of breasts with breakdown (%)).
Time frame: Up to 12 weeks postoperatively.
Time to Wound Healing
Number of days from surgery to complete epithelialization of the T-junction.
Time frame: 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.
Time frame: Postoperative days 0-6
No study locations are listed for this record.
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Dec 2027, 20 months later.
Of 15 interventional studies with no phase under Surgical Wound Dehiscence, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 32. This study's planned 20 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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