Effectiveness of TRIONIC compresses to stop abdominal oozing after deep inferior epigastric perforator breast reconstruction surgery

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2023
INTERVENTION: Patients are randomized (Interactive Web Response System [IWRS]) during surgery after electrocautery of the abdominal area. According to the randomization, patient will be treated with TRIONIC or not. TRIONIC will be applied and maintained in place until the bleeding stops. TRIONIC will be removed before closing the surgical site. Duration of follow‐up: 21 days (+/‐ 3 days). CONDITION: Female adult patients having breast reconstruction with deep inferior epigastric perforator (DIEP) flap ; Surgery PRIMARY OUTCOME: Number of days of abdominal drainage from placement of the abdominal drains until a volume of 20 ml/24 h is in each of the two drainage bottles SECONDARY OUTCOME: ; 1. Total volume of abdominal drainage fluid collected in the two drainage bottles from placement of the drains until a drainage volume =20 ml/24 h is achieved in each of the two bottles; 2. Postoperative abdominal complications:; 2.1. Percentage of patients with seroma and % of patients with haematoma during 21 days of follow‐up; 2.2. Percentage of patients with unhealed abdominal suture at 21 days after surgery; 3. Tolerance: nature and frequency of TRIONIC‐related incidents and adverse events (AEs) related to the investigation procedure; INCLUSION CRITERIA: 1. Women aged 18 years or over 2. Undergoing unilateral or bilateral DIEP flap breast reconstruction 3. Having read and understood the patient information sheet and signed a written informed consent 4. Affiliated to the French social security system (“Sécurité sociale”)
Epistemonikos ID: e91e558654d2d29fce11bdb9034b3944cf6acc74
First added on: Feb 20, 2024