Evaluating the Effect of CO2Lift Pro® Carboxy Gel on T-Junction Breakdown Rates After Breast Reduction Surgery: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treated breast
CO2 Lift Pro® Carboxygel treated breast
干预措施: Carboxygel (Other)
Placebo breast
Vaseline® control breast
干预措施: Vaseline (Other)
结局指标
主要结局
Recruitment Rate
时间窗: Through study recruitment completion, an average of 1 year
Number of participants enrolled per month during the recruitment period.
Retention Rate
时间窗: Up to 12 weeks postoperatively.
Proportion of enrolled participants completing the 12-week follow-up period.
Incidence of Treatment-Related Adverse Events
时间窗: Postoperative days 0-7 days
Number of participants experiencing any treatment-related adverse event, including local skin reactions.
Incidence of Re-operation
时间窗: Up to 12 weeks postoperatively
Number of participants requiring surgical re-intervention related to wound complications.
次要结局
- Incidence of T-Junction Breakdown(Up to 12 weeks postoperatively.)
- Time to Wound Healing(Up to 12 weeks postoperatively)
- Tissue Oxygen Saturation at the T-Junction(Postoperative days 0-6)
研究者
Justin Yeung
Principal Investigator
University of Calgary