Comparing Povidone-iodine and Saline for Preventing Infections in Colorectal Surgery
Intraoperative Irrigation of the Surgical Incision With Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection
This study is testing whether using povidone-iodine or saline to clean surgical cuts can help prevent infections in patients having colorectal surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 228 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande do Sul) |
| Trial ID | NCT06302335 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of povidone-iodine versus saline solution in reducing surgical site infections (SSI) in patients undergoing colorectal resections. Participants will be randomly assigned to receive either povidone-iodine or saline for irrigation of their surgical incisions during the procedure. The study will take place at a large university hospital in Southern Brazil, where standard care routines will remain unchanged. The outcomes of both groups will be compared to determine which irrigation method is more effective in preventing SSI.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with benign or malignant colorectal diseases scheduled for elective colectomy or proctectomy.
Not a fit: Patients who may not benefit include those under 18, those undergoing emergency surgeries, or those with known allergies to iodine.
Why it matters
Potential benefit: If successful, this study could lead to improved infection prevention strategies in colorectal surgeries, enhancing patient recovery and outcomes.
How similar studies have performed: Previous studies have shown varying results regarding the effectiveness of povidone-iodine in surgical settings, making this approach both relevant and necessary to explore further.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Porto Alegre, Rio Grande do Sul
- Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)
Study contacts
- Principal investigator: Daniel C Damin, PhD — Hospital de Clínicas de Porto Alegre
- Study coordinator: Daniel C Damin, PhD
- Email: damin@terra.com.br
- Phone: +5551996020442
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.