Surgical Site InfectionPhase 3NCT06302335
Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection
A Phase 3 study testing Povidone-iodine and Saline solution in people with Surgical Site Infection, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Povidone-iodine and Saline solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2023to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90.035-903
Daniel C Damin, +5551996020442, damin@terra.com.br
About this study
Official title: Intraoperative Irrigation of the Surgical Incision With Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection
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.
Read the detailed description
Patients will be randomized to one of the following intervention groups:
Group 1: intraoperative irrigation/washing of the surgical incision with povidone-iodine (PVP-I); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of povidone-iodine solution (PVP-I). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues. " Group 2: intraoperative irrigation/washing of the surgical incision with saline solution (NaCl 0.9%); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of saline solution (NaCl 0.9%). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues.
NOTE: other care routines for participating patients will not be changed by this study. Patients will receive mechanical colon preparation and antibiotic prophylaxis according to routines already in place by the assistant team.
Randomization: the block randomization method will be used (blocks of 4 patients each).
Groups 1 and 2 will be compared with each other regarding the outcomes.
- Conditions
- Surgical Site Infection
- Being tested
- Povidone-iodine, Saline solution
- Keywords
- surgical site infection, colorectal surgey
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-iodineDrug
Application of Povidone-iodine to the surgical wound of patients submitted to colorectal resections.
Saline solutionDrug
Application of saline solution to the surgical wound of patients submitted to colorectal resections.
| Study group | Role | What they receive |
|---|---|---|
| Povidone-iodine arm | Experimental | Patients submitted to colorectal resections using Povidone-iodine in the surgical wound. Receives: Drug: Povidone-iodine |
| Saline solution arm. | Active comparator | Patients submitted to colorectal resections using saline solution in the surgical wound. Receives: Drug: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Surgical site infection within 30 days from the surgical procedure
Measured: 30 days
Secondary outcomes (1)
Intracavitary surgical infection
Infections within the abdominal cavity
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start2 Jan 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This a randomized clinical trial involving patients undergoing colorectal surgeries who will submitted to the application of povidone-iodine versus saline solution in their surgical sites.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel C Damin, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302335
- Sponsor's protocol ID
- 2022-0442
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Irrigation of the Surgical Incision With Povidone-iodine vs Saline Solution in Colorectal Surgeries and Its Effects on the Surgical Site Infection
- ClinicalTrials.gov ID
- NCT06302335
- Acronym / sponsor ID
- 2022-0442
- Conditions
- Surgical Site Infection
- Keywords
- surgical site infection, colorectal surgey
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be randomized to one of the following intervention groups:
Group 1: intraoperative irrigation/washing of the surgical incision with povidone-iodine (PVP-I); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of povidone-iodine solution (PVP-I). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues. " Group 2: intraoperative irrigation/washing of the surgical incision with saline solution (NaCl 0.9%); Detail: after aponeurotic synthesis and immediately before cutaneous synthesis, the skin and subcutaneous tissue of the surgical incision will be irrigated and washed abundantly with approximately 500ml (depending on the size of the incision) of saline solution (NaCl 0.9%). The exact volume to be used will be the minimum volume necessary for abundant and efficient washing of the incision tissues.
NOTE: other care routines for participating patients will not be changed by this study. Patients will receive mechanical colon preparation and antibiotic prophylaxis according to routines already in place by the assistant team.
Randomization: the block randomization method will be used (blocks of 4 patients each).
Groups 1 and 2 will be compared with each other regarding the outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This a randomized clinical trial involving patients undergoing colorectal surgeries who will submitted to the application of povidone-iodine versus saline solution in their surgical sites.
| Arm | Type | Receives |
|---|---|---|
| Povidone-iodine arm | Experimental | Drug: Povidone-iodinePatients submitted to colorectal resections using Povidone-iodine in the surgical wound. |
| Saline solution arm. | Active comparator | Drug: Saline solutionPatients submitted to colorectal resections using saline solution in the surgical wound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Povidone-iodineApplication of Povidone-iodine to the surgical wound of patients submitted to colorectal resections. | Drug | Povidone-iodine arm |
| Saline solutionApplication of saline solution to the surgical wound of patients submitted to colorectal resections. | Drug | Saline solution arm. |
Primary outcome
Surgical site infection
Time frame: 30 days
Surgical site infection within 30 days from the surgical procedure
1 secondary outcome
Intracavitary surgical infection
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel C Damin, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Povidone-iodine and Saline solution in people with Surgical Site Infection, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel C Damin, PhD (+5551996020442, damin@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical site infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.