Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated breast | Experimental | CO2 Lift Pro® Carboxygel treated breast |
|
| Placebo breast | Placebo Comparator | Vaseline® control breast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboxygel | Other | The gel will be applied to cover the entire T-junction after breast reduction surgery, once a day for 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of T-Junction Breakdown | Presence of wound dehiscence at the T-junction, assessed by blinded adjudication (Proportion of breasts with breakdown (%)). | Up to 12 weeks postoperatively. |
| Time to Wound Healing |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merry Faye Graff, MSc | Contact | 5876642280 | merryfaye.graff1@ucalgary.ca |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013529 | Surgical Wound Dehiscence |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
| Vaseline | Other | Vaseline will be applied to the entire T-junction after breast reduction surgery once a day for 7 days |
|
|
Number of days from surgery to complete epithelialization of the T-junction.
| 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. | Postoperative days 0-6 |