About this trial
Post-surgical adhesions occur in up to 90% of abdominal surgeries, often leading to complications like adhesive small bowel obstruction (ASBO) and chronic pain. They result from imbalanced healing processes influenced by growth factors, fibroblast activity, and genetic predispositions. While surgery can relieve ASBO, it frequently causes new adhesions, with recurrence rates up to 40%. Anti-adhesion barriers, such as the starch-based 4DryField® PH, form a temporary gel barrier to support healing. Though promising, its role in preventing ASBO recurrence is not well studied. This study evaluates whether intra-operative use of 4DryField® PH reduces ASBO recurrence over 12 months and compares perioperative outcomes in treated vs. untreated patients.
Eligibility criteria
Qualifiers
Undergoing surgical treatment for adhesive small bowel obstruction (ASBO)
Ability and willingness to provide informed consent
Willingness to adhere to follow-up visits
Disqualifiers
Presence of peritonitis
Intra-abdominal active malignancy
Pregnancy or breastfeeding
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
Sponsors and collaborators
Alessio Giordano
Lead sponsor
Azienda Sanitaria di Firenze
Sponsor institution
PlantTec Medical GmbH
Collaborator