Drain Output After Breast Reduction Surgery, Breast Reductions
Conditions
Keywords
TXA, Tranexamic Acid, Breast Reduction, Postoperative Drainaige, Plastic Surgery, Randomized Controlled Trial, RCT
Brief summary
This study aims to evaluate whether tranexamic acid (TXA), a medication that helps reduce bleeding, can decrease fluid drainage after breast reduction surgery. Participants will be randomly assigned to receive either intravenous TXA or no TXA during surgery. Additionally, one breast will receive TXA through the surgical drain, while the other will receive saline. This approach allows to compare the effects of TXA on fluid buildup and healing. The goal is to improve recovery and reduce complications after breast reduction surgery.
Detailed description
This single-center, prospective, randomized controlled trial investigates the effect of tranexamic acid (TXA) on postoperative drain output and recovery following bilateral reduction mammaplasty. While TXA is widely utilized to minimize intraoperative blood loss, its role in optimizing postoperative wound healing and fluid management in plastic surgery remains underexplored. Participants undergoing bilateral breast reduction will be randomized to receive either intravenous TXA or no TXA at the time of surgery. In addition, each breast will be independently randomized to receive TXA or saline via the closed-suction drain after skin closure. This split-body design enables a controlled intra-individual comparison of local TXA effects, while concurrently assessing systemic administration in a parallel fashion. Primary outcomes include total drain output per breast and time to drain removal. Secondary endpoints include the incidence of postoperative hematoma and patient reported outcomes. All outcome measures will be recorded using standardized protocols and assessed by blinded evaluators where applicable. Participants will be followed until 30 days postoperatively. Given the established safety profile of TXA and the relatively low-risk nature of the intervention, no independent data monitoring committee has been appointed. The study has been approved by the local IRB and will adhere to institutional standards for adverse event monitoring and reporting.
Interventions
DRUGIV TXA
Patients randomized to the IV TXA group will receive intravenous Tranexamic acid during the procedure. The dose will be 1g IV infused over approx. 10 minutes prior to skin closure (dosing of approx. 15 mg/kg, capped at 1 g, which is within safe limits).
DRUGTopical TXA
Before wound closure, one 15mm round Jackson-Pratt (JP) drain is placed in each breast pocket, exiting through a lateral chest wall stab incision. The randomized topical TXA intervention is then applied through the drain into the breast after skin closure. The drains will then be temporarily clamped for 20 minutes to allow the TXA to dwell in the tissue and exert local effect. After this the clamp is released, the excess fluid sucked off and the drain connected to a drainage bottle.
DRUGTopical saline
Before wound closure, one 15mm round Jackson-Pratt (JP) drain is placed in each breast pocket, exiting through a lateral chest wall stab incision. The randomized saline intervention is then applied through the drain into the breast after skin closure. The drains will then be temporarily clamped for 20 minutes to allow the saline to dwell in the tissue and exert local effect. After this the clamp is released, the excess fluid sucked off and the drain connected to a drainage bottle.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Participants are randomized to either receive intravenous tranexamic acid (TXA) or no TXA during bilateral breast reduction surgery. Within each participant, a split-breast design is applied: one breast is treated with topical TXA through the surgical drain, while the contralateral breast receives saline
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older * Elective bilateral breast reduction * Patient understands and is willing to participate in the study * Patient willing to and capable of providing informed consent
Exclusion criteria
* Age less than 18 years old * Prior radiation to the breast * Secondary/Revision breast reduction * Known coagulopathy or bleeding disorders * Intraoperative coagulopathy * History of seizures * Active smokers * Allergy or contraindication to TXA * Pregnant or breastfeeding patients * Patient is unable or unwilling to complete the anticipated study follow-up * Inability to understand the aims and objectives of the study * Inability to or unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total drain output per breast per 24 hours post-surgery (mL) until drain removal | From date of operation until drain removal up to 4 weeks. | Drain outputs will be recorded separately for each breast twice daily until removal. |
| Time to drain removal (days) | From date of operation until drain removal up to 4 weeks. | Drains will be removed per standard protocol by trained staff if the output is ≤30 mL in a 24-hour period for two consecutive days. The time to drain removal will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection Rate | From date of surgery until end of study (30 days postoperative). | Rate of surgical site infections (superficial or deep) diagnosed based on CDC criteria during the postoperative period. |
| Hematoma Rate | From date of surgery until end of study (30 days postoperative). | Rate of postoperative hematoma formation. Diagnosis will be based on physical examination and/or via imaging, if clinically indicated. |
| Wound Dehiscence Rate | From date of surgery until end of study (30 days postoperative). | Rate of postoperative wound dehiscence identified clinically, including any spontaneous reopening of the surgical incision. |
| Change in drain fluid color from bloody to serous until drain removal assessed by daily observation | From postoperative Day 1 until drain removal, up to 4 weeks after surgery | Qualitative change in drain fluid from bloody to serous. Measured by daily observation by clinical staff until drain removal. Change will be recorded as transition from bloody to serous. |
| 30-Day Readmission Rate | From date of surgery until end of study (30 days postoperative) | Rate of patients readmitted to the hospital within 30 days of the index surgery, regardless of cause. |
| 30-Day Revision Rate | From date of surgery until end of study (30 days postoperative). | Rate of reoperation or revision procedures performed within 30 days postoperatively due to complications. |
| Patient-Reported Outcomes (BREAST-Q Breast Reduction Module) | Preoperative before surgery, 7 days after and 30 days after surgery. | The BREAST-Q Breast Reduction Module is a validated patient-reported outcome measure assessing satisfaction and quality of life following breast reduction surgery. Each subscale is scored from 0 to 100, with higher scores indicating greater satisfaction and/or better quality of life. |
| Length of Hospital Stay | From date of surgery until discharge from the hospital up to 4 weeks. | Duration of inpatient stay postoperatively, measured in days from the date of surgery to the date of discharge. |
| Seroma Rate | From date of surgery until end of study (30 days postoperative). | Rate of clinically evident seromas in the postoperative follow-up period. Diagnosis will be based on physical examination and/or ultrasound when clinically indicated. |
Countries
United States
Outcome results
None listed