CO2Lift and T-Junction Breakdown Rates Evaluation After Breast Reduction Surgery Pilot Trial

N/ANot Yet RecruitingNCT07408960

University of Calgary10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Wound Breakdown Breast Reduction

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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