Wound Breakdown, Breast Reduction, Surgical Wound, Breast Surgery
Conditions
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.
Interventions
OTHERCarboxygel
The gel will be applied to cover the entire T-junction after breast reduction surgery, once a day for 7 days.
OTHERVaseline
Vaseline will be applied to the entire T-junction after breast reduction surgery once a day for 7 days
Sponsors
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | Through study recruitment completion, an average of 1 year | Number of participants enrolled per month during the recruitment period. |
| Retention Rate | Up to 12 weeks postoperatively. | Proportion of enrolled participants completing the 12-week follow-up period. |
| Incidence of Treatment-Related Adverse Events | Postoperative days 0-7 days | Number of participants experiencing any treatment-related adverse event, including local skin reactions. |
| Incidence of Re-operation | Up to 12 weeks postoperatively | Number of participants requiring surgical re-intervention related to wound complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of T-Junction Breakdown | Up to 12 weeks postoperatively. | Presence of wound dehiscence at the T-junction, assessed by blinded adjudication (Proportion of breasts with breakdown (%)). |
| Time to Wound Healing | Up to 12 weeks postoperatively | Number of days from surgery to complete epithelialization of the T-junction. |
| Tissue Oxygen Saturation at the T-Junction | Postoperative days 0-6 | Change in tissue oxygen saturation (StO₂) measured using near-infrared spectroscopy before and after treatment application. |
Contacts
CONTACTMerry Faye Graff, MSc
Outcome results
None listed