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

Not Applicable

Active, not recruiting

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

• Registration Number: ISRCTN18170773
• Lead Sponsor: Brothier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-18
• Last Update Posted: 13 June 2023
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 148

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified