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Adhesion Prevention in ASBO Surgery Using 4DryField® PH

NCT07078981 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 189

Last updated 2025-07-22

No results posted yet for this study

Summary

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.

Conditions

  • Adhesive Small Bowel Obstruction
  • Postoperative Abdominal Adhesions
  • Bowel Obstruction
  • Abdominal Surgery Complications

Sponsors & Collaborators

  • PlantTec Medical GmbH

    collaborator UNKNOWN

  • Alessio Giordano

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2026-07-15
Completion
2027-07-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07078981 on ClinicalTrials.gov