CO2Lift and T-Junction Breakdown Rates Evaluation After Breast Reduction Surgery Pilot Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorUniversity of Calgary
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Carboxygel
Other interventionThe gel will be applied to cover the entire T-junction after breast reduction surgery, once a day for 7 days.
Vaseline
Other interventionVaseline will be applied to the entire T-junction after breast reduction surgery once a day for 7 days
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Treated breastExperimental treatment 1 intervention
Group B: Placebo breastPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment Rate
Number of participants enrolled per month during the recruitment period.
Time frame
Through study recruitment completion, an average of 1 year2
Retention Rate
Proportion of enrolled participants completing the 12-week follow-up period.
Time frame
Up to 12 weeks postoperatively.3
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 days4
Incidence of Re-operation
Number of participants requiring surgical re-intervention related to wound complications.
Time frame
Up to 12 weeks postoperativelySecondary outcomes
1
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.2
Time to Wound Healing
Number of days from surgery to complete epithelialization of the T-junction.
Time frame
Up to 12 weeks postoperatively3
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 0-6Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: