Adhesion Prevention in ASBO Surgery Using 4DryField® PH

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAlessio Giordano

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

189 Participants
are grouped into 2 trial groups

Locations

This trial has no locations

Sponsors and collaborators

Alessio Giordano

Lead sponsor

Azienda Sanitaria di Firenze

Sponsor institution

PlantTec Medical GmbH

Collaborator