Double-blind Pilot Study on the Effect of Anionic Exposome Enrichment (Biow) on Recovery and Sleep Quality in Postoperative Patients
Recruiting
Phase 1
Phase 2
Interventional Study
Inflammatory Response After Surgery
Postoperative Recovery
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Supportive Care
- Participants needed
- 150 (estimated)
- Sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Other
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About This Trial
Airborne nanoparticle exposure is increasingly recognized as a significant contributor to oxidative stress, mitochondrial dysfunction, and low-grade systemic inflammation-factors that impair postoperative recovery. The World Health Organization and European initiatives such as the Human Exposome Project have highlighted the clinical importance of the exposome, defined as the totality of environmen…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adults aged ≥18 years, regardless of sex.
* Undergoing elective general surgery, preferably hepatobiliary procedures.
* Hospitalized for at least 4 days postoperatively in Unit 69 (HUFJD).
* Able to provide written informed consent.
* Considered to have medium or high risk of …
Contacts
No contact information available.