WoundNCT06667089
Povidone-Iodine Versus Chlorhexidine in Surgical Wound Care
A study testing Povidone-Iodine and Chlorhexidine in people with Wound, run by University of Jaén at 1 site in Spain.
Trial summary
This comparison examines the effectiveness of povidone-iodine and chlorhexidine in managing iatrogenic wounds in surgical patients. Both antiseptics are commonly used to prevent postoperative infections, but they differ in mechanism, efficacy, and safety profiles. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Wound
- What is being tested?
- Povidone-Iodine and Chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteSpain
- Study dates
- 7 Jan 2025to 4 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Elderly patients undergoing surgical procedures resulting in iatrogenic wounds (surgical wounds of various specialties, such as abdominal, orthopedic, cardiovascular, etc.).
- Availability for follow-up during the postoperative period, ensuring attendance at medical check-ups for the evaluation of healing and prevention of infections.
- Ability to provide informed consent, understanding the objectives, risks and benefits of the study.
- Absence of previous infections at the surgical site, ensuring that the wounds are recent and derived from the current surgical procedure.
Who cannot join
- Known allergies or hypersensitivity to povidone iodine or chlorhexidine, to avoid risks of serious adverse reactions.
- Immunocompromised patients, such as those with advanced HIV, on immunosuppressant treatment, or with decompensated chronic diseases (poorly controlled diabetes, kidney failure, etc.), due to increased susceptibility to infections and altered healing.
- Patients with active infections or infected wounds prior to surgery, to avoid biasing the results by pre-existing infections.
- Pregnancy or breastfeeding, due to safety considerations and the possible alteration of healing and immunity processes during these stages.
- Use of other antiseptics or topical treatments at the wound site that may interfere with the efficacy of povidone iodine or chlorhexidine.
- Patients with known wound healing disorders (such as autoimmune diseases or hematological disorders), which may affect the results in terms of healing time and quality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Povidone-Iodine and Chlorhexidine in the Management of Iatrogenic Wounds in Surgical Patients
This comparison examines the effectiveness of povidone-iodine and chlorhexidine in managing iatrogenic wounds in surgical patients. Both antiseptics are commonly used to prevent postoperative infections, but they differ in mechanism, efficacy, and safety profiles. Povidone-iodine releases iodine, which acts broadly against bacteria, viruses, and fungi, while chlorhexidine disrupts cell membranes, providing rapid bactericidal action. Studies suggest that chlorhexidine may offer longer-lasting antibacterial effects, but povidone-iodine has a wider antimicrobial range. Optimal choice depends on patient needs, wound type, and potential for adverse reactions, emphasizing the need for tailored antiseptic strategies in wound care.
- Conditions
- Wound
- Being tested
- Povidone-Iodine, Chlorhexidine
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-IodineOther
The povidone-iodine group will receive a 10% povidone-iodine solution or gel applied directly to the wound after gentle cleaning, with the treatment applied according to a set frequency, typically twice daily. This antiseptic will be left on the wound for a brief period to enhance its antimicrobial action.
ChlorhexidineOther
The chlorhexidine group will receive a chlorhexidine solution, usually at a concentration of 0.5% to 2%, applied similarly after cleaning the wound. This solution will remain on the wound according to protocol guidelines, also typically applied twice daily. Both groups will be monitored for adverse reactions, signs of infection, and the overall effectiveness of wound healing throughout the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Povidone-Iodine Group | Experimental | The povidone-iodine group will receive applications of 10% povidone-iodine solution or gel directly on the wound area involving a gentle cleaning of the wound followed by the application of povidone-iodine left on for a brief period to maximize its antimicrobial action with treatment applied according to protocol frequency, such as twice daily or as clinically indicated, with close monitoring for any adverse reactions or signs of infection Receives: Other: Povidone-Iodine |
| Chlorhexidine Group | Experimental | The chlorhexidine group will receive applications of chlorhexidine solution, typically at a concentration of 0.5% to 2%, also following a gentle cleaning of the wound area before applying chlorhexidine, which will remain on the wound according to protocol guidelines with a similar frequency and monitoring approach to assess for antimicrobial effectiveness, wound healing progress, and potential skin irritation Receives: Other: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS)
The Numerical Rating Scale is a pain assessment tool where patients rate their pain intensity on a scale from 0 to 10, with 0 indicating "no pain" and 10 representing "the worst possible pain." The interpretation of the scores is categorized into levels of pain severity: a score of 0-3 denotes mild pain, 4-6 indicates moderate pain, and 7-10 reflects severe pain. This categorization allows healthcare providers to gauge the patient's pain experience effectively, guiding treatment decisions and evaluating the efficacy of pain management strategies.
Measured: Up to twelve weeks
EuroQol-5D (EQ-5D)
The EuroQol-5D is a standardized instrument for measuring health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The results yield a single index score that typically ranges from -0.594 (worse than death) to 1 (optimal health). Scores are interpreted as follows: 0.0 signifies an average quality of life, 0.5 to 0.8 indicates moderate impairment, and 0.9 to 1.0 reflects high quality of life. These scores are essential for assessing the impact of interventions on patient quality of life.
Measured: Up to twelve weeks
Patient Satisfaction Questionnaire (PSQ)
The Patient Satisfaction Questionnaire assesses patient satisfaction with healthcare services, using a scale from 1 to 5, where 1 represents "very dissatisfied" and 5 indicates "very satisfied." Interpretation of the scores categorizes satisfaction levels: 1-2 denotes low satisfaction, 3 represents average satisfaction, and 4-5 indicates high satisfaction. Higher scores suggest improvements in service quality and patient care, providing valuable feedback for healthcare providers to enhance their practices.
Measured: Up to twelve weeks
Wound Healing Assessment Tool
This tool encompasses various metrics for evaluating wound characteristics, such as size, depth, and signs of infection. Interpretation of the results varies depending on the specific metrics used, but generally, a decrease in wound size and the absence of infection signs signify effective healing. Conversely, the presence of necrosis or an increase in wound size may indicate complications. Higher scores typically correlate with better healing outcomes, guiding clinicians in treatment decisions and monitoring progress.
Measured: Up to twelve weeks
Adverse Event Reporting Form
This form is used to document any adverse reactions or events experienced by patients during treatment. The results are analyzed to calculate the incidence rate of adverse events, with lower rates suggesting that the treatment is safe and well-tolerated. Conversely, a higher frequency of adverse events may indicate safety concerns, prompting further investigation and potential modifications in treatment protocols. These findings are critical for evaluating the safety profile of interventions and informing clinical practice.
Measured: Up to twelve weeks
Secondary outcomes (2)
Hospital Anxiety and Depression Scale (HADS)
Assesses symptoms of anxiety and depression using 14 items (7 for each subscale), each scored from 0 to 3. Scores range from 0 to 21 for anxiety and for depression, where 0-7 is normal, 8-10 indicates possible symptoms, and 11 or higher suggests a clinical disorder.
Measured: Up to twelve weeks
Pittsburgh Sleep Quality Index (PSQI)
A simple and valid assessment of both sleep quality and disturbance that might affect. They consist of 10 questions divided into four subscales: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep discomfort, medication use and daytime dysfunctions, adding up to a total score. The higher value represents a worse result. Higher scores indicate poorer sleep.
Measured: Up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start7 Jan 2025
- Primary completion1 Apr 2025
- Study completion4 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agustín Aibar Almazán, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667089
- Sponsor's protocol ID
- University of Jaén¨
- Status last verified
- Apr 2025
- First submitted
- 29 Oct 2024
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Povidone-Iodine and Chlorhexidine in the Management of Iatrogenic Wounds in Surgical Patients
- ClinicalTrials.gov ID
- NCT06667089
- Acronym / sponsor ID
- University of Jaén¨
- Conditions
- Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 31 Oct 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.
This comparison examines the effectiveness of povidone-iodine and chlorhexidine in managing iatrogenic wounds in surgical patients. Both antiseptics are commonly used to prevent postoperative infections, but they differ in mechanism, efficacy, and safety profiles. Povidone-iodine releases iodine, which acts broadly against bacteria, viruses, and fungi, while chlorhexidine disrupts cell membranes, providing rapid bactericidal action. Studies suggest that chlorhexidine may offer longer-lasting antibacterial effects, but povidone-iodine has a wider antimicrobial range. Optimal choice depends on patient needs, wound type, and potential for adverse reactions, emphasizing the need for tailored antiseptic strategies in wound care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Povidone-Iodine Group | Experimental | Other: Povidone-IodineThe povidone-iodine group will receive applications of 10% povidone-iodine solution or gel directly on the wound area involving a gentle cleaning of the wound followed by the application of povidone-iodine left on for a brief period to maximize its antimicrobial action with treatment applied according to protocol frequency, such as twice daily or as clinically indicated, with close monitoring for any adverse reactions or signs of infection |
| Chlorhexidine Group | Experimental | Other: ChlorhexidineThe chlorhexidine group will receive applications of chlorhexidine solution, typically at a concentration of 0.5% to 2%, also following a gentle cleaning of the wound area before applying chlorhexidine, which will remain on the wound according to protocol guidelines with a similar frequency and monitoring approach to assess for antimicrobial effectiveness, wound healing progress, and potential skin irritation |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Elderly patients undergoing surgical procedures resulting in iatrogenic wounds (surgical wounds of various specialties, such as abdominal, orthopedic, cardiovascular, etc.).
- Availability for follow-up during the postoperative period, ensuring attendance at medical check-ups for the evaluation of healing and prevention of infections.
- Ability to provide informed consent, understanding the objectives, risks and benefits of the study.
- Absence of previous infections at the surgical site, ensuring that the wounds are recent and derived from the current surgical procedure.
Key exclusion criteria (6 listed)
- Known allergies or hypersensitivity to povidone iodine or chlorhexidine, to avoid risks of serious adverse reactions.
- Immunocompromised patients, such as those with advanced HIV, on immunosuppressant treatment, or with decompensated chronic diseases (poorly controlled diabetes, kidney failure, etc.), due to increased susceptibility to infections and altered healing.
- Patients with active infections or infected wounds prior to surgery, to avoid biasing the results by pre-existing infections.
- Pregnancy or breastfeeding, due to safety considerations and the possible alteration of healing and immunity processes during these stages.
- Use of other antiseptics or topical treatments at the wound site that may interfere with the efficacy of povidone iodine or chlorhexidine.
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-IodineThe povidone-iodine group will receive a 10% povidone-iodine solution or gel applied directly to the wound after gentle cleaning, with the treatment applied according to a set frequency, typically twice daily. This antiseptic will be left on the wound for a brief period to enhance its antimicrobial action. | Other | Povidone-Iodine Group |
| ChlorhexidineThe chlorhexidine group will receive a chlorhexidine solution, usually at a concentration of 0.5% to 2%, applied similarly after cleaning the wound. This solution will remain on the wound according to protocol guidelines, also typically applied twice daily. Both groups will be monitored for adverse reactions, signs of infection, and the overall effectiveness of wound healing throughout the treatment period. | Other | Chlorhexidine Group |
Primary outcome
Numerical Rating Scale (NRS)
Time frame: Up to twelve weeks
The Numerical Rating Scale is a pain assessment tool where patients rate their pain intensity on a scale from 0 to 10, with 0 indicating "no pain" and 10 representing "the worst possible pain." The interpretation of the scores is categorized into levels of pain severity: a score of 0-3 denotes mild pain, 4-6 indicates moderate pain, and 7-10 reflects severe pain. This categorization allows healthcare providers to gauge the patient's pain experience effectively, guiding treatment decisions and evaluating the efficacy of pain management strategies.
EuroQol-5D (EQ-5D)
Time frame: Up to twelve weeks
The EuroQol-5D is a standardized instrument for measuring health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The results yield a single index score that typically ranges from -0.594 (worse than death) to 1 (optimal health). Scores are interpreted as follows: 0.0 signifies an average quality of life, 0.5 to 0.8 indicates moderate impairment, and 0.9 to 1.0 reflects high quality of life. These scores are essential for assessing the impact of interventions on patient quality of life.
Patient Satisfaction Questionnaire (PSQ)
Time frame: Up to twelve weeks
The Patient Satisfaction Questionnaire assesses patient satisfaction with healthcare services, using a scale from 1 to 5, where 1 represents "very dissatisfied" and 5 indicates "very satisfied." Interpretation of the scores categorizes satisfaction levels: 1-2 denotes low satisfaction, 3 represents average satisfaction, and 4-5 indicates high satisfaction. Higher scores suggest improvements in service quality and patient care, providing valuable feedback for healthcare providers to enhance their practices.
Wound Healing Assessment Tool
Time frame: Up to twelve weeks
This tool encompasses various metrics for evaluating wound characteristics, such as size, depth, and signs of infection. Interpretation of the results varies depending on the specific metrics used, but generally, a decrease in wound size and the absence of infection signs signify effective healing. Conversely, the presence of necrosis or an increase in wound size may indicate complications. Higher scores typically correlate with better healing outcomes, guiding clinicians in treatment decisions and monitoring progress.
Adverse Event Reporting Form
Time frame: Up to twelve weeks
This form is used to document any adverse reactions or events experienced by patients during treatment. The results are analyzed to calculate the incidence rate of adverse events, with lower rates suggesting that the treatment is safe and well-tolerated. Conversely, a higher frequency of adverse events may indicate safety concerns, prompting further investigation and potential modifications in treatment protocols. These findings are critical for evaluating the safety profile of interventions and informing clinical practice.
2 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: Up to twelve weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Up to twelve weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Povidone-Iodine and Chlorhexidine in people with Wound, run by University of Jaén at 1 site in Spain.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Apr 2025. 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 Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) (time frame: Up to twelve weeks). The study lists 5 primary outcomes in all. 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 22 Apr 2025.