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NCT Number: NCT07078981

Adhesion Prevention in ASBO Surgery Using 4DryField® PH

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.

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Key information

About this study

Post-surgical adhesions are a common complication of abdominal surgery, with an occurrence rate of approximately 79-90%, leading to significant morbidity such as adhesive small bowel obstruction (ASBO) and chronic pain (1,2). These adhesions result from increased extracellular matrix production, reduced fibrinolytic activity, and the influence of growth factors like TGF-beta and VEGF, along with fibroblast proliferation(1). Genetic predispositions-affecting pathways such as TGF-β, VEGF, PAI-1, MMPs, and various pro-inflammatory cytokines-may increase the risk of adhesion formation(2-5).

Surgical management of ASBO resolves acute symptoms but often exacerbates the underlying issue by inducing further peritoneal trauma. Recurrence rates remain high-reported in up to 40% of patients-and complications from repeated adhesiolysis include increased operative time, bowel injury, and postoperative morbidity(6).

Various strategies have been explored in different surgical fields to prevent adhesion formation, including the use of physical antiadhesion barriers(7-9). Among these, 4DryField® PH, a plant-derived starch powder, has been shown to be safe and effective in clinical and experimental studies(8,10). When hydrated with saline, the powder forms a biocompatible gel that acts as a temporary barrier to physically separate traumatized serosal surfaces and allow for proper mesothelial regeneration.

Although the use of 4DryField® PH has been studied in different settings, there is limited prospective evidence evaluating its role in preventing recurrence of ASBO.

The present study aims to fill this gap by assessing whether intraoperative application of 4DryField® PH during surgery for ASBO reduces the recurrence rate during a 12-month follow-up, and by comparing perioperative outcomes between treated and untreated patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years

  • Undergoing surgical treatment for adhesive small bowel obstruction (ASBO)
  • Ability and willingness to provide informed consent
  • Willingness to adhere to follow-up visits

Exclusion criteria

  • Presence of peritonitis
  • Intra-abdominal active malignancy
  • Pregnancy or breastfeeding

Treatment and study plan

Primary outcomes

  1. Recurrence rate of adhesive small bowel obstruction (ASBO) within 12 months

    Time frame: 12 months post-surgery

    Percentage of patients who experience a recurrence of adhesive small bowel obstruction (ASBO), based on clinical symptoms and imaging findings, during the 12-month follow-up period. Recurrence is defined by standardized clinical criteria (e.g. intermittent pain, nausea, vomiting, bowel obstruction symptoms) with or without radiological confirmation.

Secondary outcomes

  1. Postoperative complications within 90 days

    Time frame: 90 days post-surgery

    Incidence and type of postoperative complications occurring within 90 days after surgery, classified according to Clavien-Dindo classification.

Study contacts

Contact information is provided by the study sponsor or research team.

carlo bergamini, MD, General Surgeon

CONTACT

[email protected]

+393476360711

Sponsors and collaborators

Lead sponsor

Alessio Giordano

Other

Collaborators

  • PlantTec Medical GmbH

Registry information

Official study title

Assessing Determinants of Headway in Evaluating Risk of Adhesion: the ADHERE Study

Acronym: ADHERE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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