Protecting Autologous Free Flaps From Ischemia/Reperfusion Damage With Cold Storage.
Launched by UNIVERSITY OF CAGLIARI · Jul 23, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new method to help protect tissue flaps used in reconstructive surgery from damage that can occur when blood flow is temporarily stopped (a condition called ischemia) and then restored (reperfusion). The researchers believe that storing these flaps in a cold solution may reduce the risk of complications after surgery. The study will focus on patients undergoing reconstructions after cancer treatment, such as for the jaw, breast, or soft tissues in the head and neck.
To be eligible for this trial, patients should be undergoing specific types of reconstructive surgery, including those who need flaps from the fibula (a leg bone), ALT (an area of the thigh), or DIEP and PAP (areas used in breast reconstruction). Unfortunately, those with certain health issues, like malnutrition or connective tissue diseases, cannot participate. Participants will have their blood flow monitored during surgery and will be evaluated afterward to see how well they recover, especially in terms of sensation and dental rehabilitation. This study aims to improve outcomes for patients undergoing these important surgeries.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Post-oncological mandible reconstruction through fibula free flap,
- • Post-oncological soft tissue reconstruction through ALT (Anterior Lateral Thigh) free flap in head and neck region
- • Post-oncological breast reconstruction through DIEP (Deep Inferior Epigastric Perforator) and PAP (Profunda femoris Artery Perforator) free flaps.
- Exclusion Criteria:
- • Malnutrition
- • Malabsorption
- • Vasculitis
- • Pathologies of the connective tissue
About University Of Cagliari
The University of Cagliari is a prominent academic institution located in Sardinia, Italy, renowned for its commitment to advancing medical research and education. With a strong emphasis on innovative clinical trials, the university leverages its interdisciplinary expertise and state-of-the-art facilities to drive advancements in healthcare. The institution collaborates with a network of researchers, clinicians, and industry partners to facilitate cutting-edge studies aimed at improving patient outcomes and addressing critical health challenges. Through its rigorous scientific approach and dedication to ethical research practices, the University of Cagliari plays a pivotal role in contributing to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Adriana Cordova, Prof
Principal Investigator
University of Palermo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported