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

Efficacy of TRIONIC after electrocautery vs electrocautery alone in controlling haemorrhagic oozing from the deep inferior epigastric perforator flap donor site - a multicenter randomized clinical investigation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18170773

Enrollment

148

Registered

2023-04-18

Start date

2023-04-27

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female adult patients having breast reconstruction with deep inferior epigastric perforator (DIEP) flap Surgery

Interventions

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.

Eligibility

Sex/Gender

Female

Inclusion criteria

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”)

Exclusion criteria

Exclusion criteria: 1. Patients with hemophilia, with Willebrand or Rendu-Osler disease or on long-term anticoagulant/antiplatelet treatment 2. Known to be allergic to the components of TRIONIC 3. End of hospitalization planned before the end of abdominal drainage 4. Might not return for the end-of-study visit 5. Under legal protection and/or unable to give written informed consent herself 6. Participating or going to participate or having taken part simultaneously in another trial which could have an impact on haemorrhagic oozing in the abdominal layer

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026