Surgical Wound InfectionPhase 4NCT05276687
Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection
A Phase 4 study testing Betadine and Vancomycin in people with Surgical Wound Infection, run by Assiut University.
Trial summary
1. Infection control and health-care-associated infections and Safety of medical service providers 2. Evidence based management of common medical and surgical problems Read more about this study
- Who is it for?
- Ages 1 year to 65 years
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Betadine and Vancomycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Apr 2024
- Phase
- Phase 4
- 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 1 year to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age from 1 to 65 years, primary or redo cases
Who cannot join
- diabetic patients
Trial locations and contacts
No sites are listed yet.
About this study
- Infection control and health-care-associated infections and Safety of medical service providers
- Evidence based management of common medical and surgical problems
Read the detailed description
Surgical wound infection is the presence of replicating micro-organisms within a wound of a surgery leading to host injury. Superficial sternal wound infection (SSWI) is the infection that affects the skin and subcutaneous tissues and the pectoralis fascia(1,2). Deep sternal wound infection (DSWI) is the infection affecting muscle layer and the bony sternum, it is one of the most complex and potentially devastating complications following median sternotomy in cardiac surgery with a significant impact on both patient prognosis and hospital budgets, despite of many advances in prevention, it is still remaining significant, and ranges between 0.5% and 6.8%(2), with in-hospital mortality between 7% and 35%. moreover, mid- and long- term survival is significantly reduced in patients that have experienced DSWI(3). Sternal dehiscence is the process of separation of bony sternum which is often accompanied by mediastinits(4). Although prevention of infection following arthroplasty requires a multifaceted approach, the use of intraoperative irrigation is an important component of any protocol. Recent clinical practice guidelines from the Centers for Disease Control, World Health Organization, and International Consensus Meeting on Musculoskeletal Infection advocate the use of a dilute povidone-iodine solution prior to wound closure. This experience suggests that this practice is safe, inexpensive, and easily implemented(5). The present study is going to discuss the effect of dilute povidone-iodine irrigation vs vancomycine irrigation intraoperative in prevention of postoperative infection after cardiac surgery.
- Conditions
- Surgical Wound Infection
- Being tested
- Betadine, Vancomycin
- 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.
BetadineDrug
Wound irrigation
VancomycinDrug
instillation in the wound
| Study group | Role | What they receive |
|---|---|---|
| Diluted betadine | Experimental | Not described Receives: Drug: Betadine |
| Powdered vancomycin | Experimental | Not described Receives: Drug: Vancomycin |
| No intervention | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superficial wound infection
Measured: Within 20 days
Deep wound infection
Measured: Within 20 days
Secondary outcomes (1)
Healing of sternum ( within 2 months)
Measured: 20 days to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2022
- Study startSep 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Hamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05276687
- Sponsor's protocol ID
- diluted betadine vs antibiotic
- Status last verified
- Mar 2022
- First submitted
- 3 Mar 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cotogni P, Barbero C, Rinaldi M. Deep sternal wound infection after cardiac surgery: Evidences and controversies. World J Crit Care Med. 2015 Nov 4;4(4):265-73. doi: 10.5492/wjccm.v4.i4.265. eCollection 2015 Nov 4.
PubMed 26557476Singh K, Anderson E, Harper JG. Overview and management of sternal wound infection. Semin Plast Surg. 2011 Feb;25(1):25-33. doi: 10.1055/s-0031-1275168.
PubMed 22294940Kotnis-Gaska A, Mazur P, Olechowska-Jarzab A, Stanisz A, Bulanda M, Undas A. Sternal wound infections following cardiac surgery and their management: a single-centre study from the years 2016-2017. Kardiochir Torakochirurgia Pol. 2018 Jun;15(2):79-85. doi: 10.5114/kitp.2018.76472. Epub 2018 Jun 25.
PubMed 30069187Asghar A, Talha KM, Amanullah M, Shahabuddin S. Comparison of figure of eight and traditional simple wire closure method to prevent dehiscence after sternal closure. J Pak Med Assoc. 2020 Nov;70(11):2001-2006. doi: 10.5455/JPMA.20135.
PubMed 33341848Goswami K, Austin MS. Intraoperative povidone-iodine irrigation for infection prevention. Arthroplast Today. 2019 May 22;5(3):306-308. doi: 10.1016/j.artd.2019.04.004. eCollection 2019 Sep.
PubMed 31516971
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diluted Betadine vs Antibiotic Installation Before Surgical Wound Closure in Prevention of Post Cardiac Surgery Wound Infection
- ClinicalTrials.gov ID
- NCT05276687
- Acronym / sponsor ID
- diluted betadine vs antibiotic
- Conditions
- Surgical Wound Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 11 Mar 2022 (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.
- Infection control and health-care-associated infections and Safety of medical service providers
- Evidence based management of common medical and surgical problems
Detailed description
Surgical wound infection is the presence of replicating micro-organisms within a wound of a surgery leading to host injury. Superficial sternal wound infection (SSWI) is the infection that affects the skin and subcutaneous tissues and the pectoralis fascia(1,2). Deep sternal wound infection (DSWI) is the infection affecting muscle layer and the bony sternum, it is one of the most complex and potentially devastating complications following median sternotomy in cardiac surgery with a significant impact on both patient prognosis and hospital budgets, despite of many advances in prevention, it is still remaining significant, and ranges between 0.5% and 6.8%(2), with in-hospital mortality between 7% and 35%. moreover, mid- and long- term survival is significantly reduced in patients that have experienced DSWI(3). Sternal dehiscence is the process of separation of bony sternum which is often accompanied by mediastinits(4). Although prevention of infection following arthroplasty requires a multifaceted approach, the use of intraoperative irrigation is an important component of any protocol. Recent clinical practice guidelines from the Centers for Disease Control, World Health Organization, and International Consensus Meeting on Musculoskeletal Infection advocate the use of a dilute povidone-iodine solution prior to wound closure. This experience suggests that this practice is safe, inexpensive, and easily implemented(5). The present study is going to discuss the effect of dilute povidone-iodine irrigation vs vancomycine irrigation intraoperative in prevention of postoperative infection after cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diluted betadine | Experimental | Drug: Betadine |
| Powdered vancomycin | Experimental | Drug: Vancomycin |
| No intervention | No intervention | – |
Who may qualify
- Ages
- 1 year to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- age from 1 to 65 years, primary or redo cases
Key exclusion criteria (1 listed)
- diabetic patients
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 |
|---|---|---|
| BetadineWound irrigation | Drug | Diluted betadine |
| Vancomycininstillation in the wound | Drug | Powdered vancomycin |
Primary outcome
Superficial wound infection
Time frame: Within 20 days
Deep wound infection
Time frame: Within 20 days
1 secondary outcome
Healing of sternum ( within 2 months)
Time frame: 20 days to 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Background: PubMed 26557476Cotogni P, Barbero C, Rinaldi M. Deep sternal wound infection after cardiac surgery: Evidences and controversies. World J Crit Care Med. 2015 Nov 4;4(4):265-73. doi: 10.5492/wjccm.v4.i4.265. eCollection 2015 Nov 4.
- Background: PubMed 22294940Singh K, Anderson E, Harper JG. Overview and management of sternal wound infection. Semin Plast Surg. 2011 Feb;25(1):25-33. doi: 10.1055/s-0031-1275168.
- Background: PubMed 30069187Kotnis-Gaska A, Mazur P, Olechowska-Jarzab A, Stanisz A, Bulanda M, Undas A. Sternal wound infections following cardiac surgery and their management: a single-centre study from the years 2016-2017. Kardiochir Torakochirurgia Pol. 2018 Jun;15(2):79-85. doi: 10.5114/kitp.2018.76472. Epub 2018 Jun 25.
- Background: PubMed 33341848Asghar A, Talha KM, Amanullah M, Shahabuddin S. Comparison of figure of eight and traditional simple wire closure method to prevent dehiscence after sternal closure. J Pak Med Assoc. 2020 Nov;70(11):2001-2006. doi: 10.5455/JPMA.20135.
- Background: PubMed 31516971Goswami K, Austin MS. Intraoperative povidone-iodine irrigation for infection prevention. Arthroplast Today. 2019 May 22;5(3):306-308. doi: 10.1016/j.artd.2019.04.004. eCollection 2019 Sep.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Betadine and Vancomycin in people with Surgical Wound Infection, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelrahman Hamed Ahmed (00201060048430, Abdelrahman.hamed.ed@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Superficial wound infection (time frame: Within 20 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05276687, which also lists 5 linked publications.
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 11 Mar 2022.