NCT06302335 Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection
| NCT ID | NCT06302335 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| Condition | Surgical Site Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2023-01-02 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 228 participants in total. It began in 2023-01-02 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Considering the relatively high incidence of surgical site infection (SSI) in colorectal surgery, this trial will compare rates of SSI in patients undergoing colorectal resections followed by surgical wound irrigation with povidone-iodine versus the group of patients undergoing surgical wound irrigation with saline solution. The trial will be conducted in a large university hospital in Southern Brazil.
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years of age diagnosed with benign or malignant colorectal diseases undergoing elective open or video-assisted colectomy or proctectomy (resection) at the Hospital de Clinicas de Porto Alegre - Division of Coloproctology. Exclusion Criteria: * age under 18; * surgery classified as dirty; * urgent/emergency surgery; * patients undergoing multi-visceral resections (pelvic exenteration or partial resection of any adjacent organ); * known allergy to iodine.
Contact & Investigator
Daniel C Damin, PhD
PRINCIPAL INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Frequently Asked Questions
Who can join the NCT06302335 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgical Site Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06302335 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 228 participants.
Is NCT06302335 currently recruiting?
Yes, NCT06302335 is actively recruiting participants. Contact the research team at damin@terra.com.br for enrollment information.
Where is the NCT06302335 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil.
Who is sponsoring the NCT06302335 clinical trial?
NCT06302335 is sponsored by Hospital de Clinicas de Porto Alegre. The principal investigator is Daniel C Damin, PhD at Hospital de Clínicas de Porto Alegre. The trial plans to enroll 228 participants.