Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:18 AM
Study NCT ID:
NCT07408960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-13
First Post:
2025-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CO2Lift and T-Junction Breakdown Rates Evaluation After Breast Reduction Surgery Pilot Trial
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Evaluating the Effect of CO2Lift Pro® Carboxy Gel on T-Junction Breakdown Rates After Breast Reduction Surgery: A Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CO2-BREAST
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: