Efficacy Povidone Soaked Suture in Reducing Surgical Site InfectionNCT05090176
Title: Povidone-soaked Sutures Versus Ordinary Sutures for Reducing Surgical Site Infection
A study testing povidone-soaked suture and ordinary suture in people with Efficacy Povidone Soaked Suture in Reducing Surgical Site Infection, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
To determine efficacy of using 3 minutes povidone-soaked suture in reducing surgical site infection during wound closure in elective surgery. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Efficacy Povidone Soaked Suture in Reducing Surgical Site Infection
- What is being tested?
- povidone-soaked suture and ordinary suture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteMalaysia
- Study dates
- 2 Nov 2020to 2 Nov 2021
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age more than 12 years old
- Clean surgery or Clean- contaminated surgery
- Elective surgery
Who cannot join
- Age less than 12 years old
- Contaminated wound
- Dirty wound
- Allergy to povidone-iodine
- Pregnant
- Laparoscopic
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Title: Povidone-soaked Sutures Versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia
To determine efficacy of using 3 minutes povidone-soaked suture in reducing surgical site infection during wound closure in elective surgery.
Read the detailed description
Participant recruitment and randomisation based on eligibility based on CONSORT.
Patient will get either package A or B which determine whether they are getting povidone-soaked suture or ordinary suture during wound closure.
Postoperative, follow up on D10 and D30 of patient well being and signs and symptoms of surgical site infection
- Being tested
- povidone-soaked suture, ordinary suture
- Keywords
- suture, povidone, surgical site infection
- 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-soaked sutureOther
suture soak with povidone solution for 3 mins
ordinary sutureOther
suture no need to soak with povidone solution
| Study group | Role | What they receive |
|---|---|---|
| povidone-soaked suture | Experimental | The patient is randomized, those with povidone-soaked suture group will be prepared for povidone-soaked suture during wound closure.
The absorbable suture will be soaked into povidone for 3 mins before the wound closure. Receives: Other: povidone-soaked suture |
| ordinary suture | Active comparator | the patient is randomized, those with ordinary suture group will proceed with wound closure as usual manner following the standard practice. Receives: Other: ordinary suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia
There is difference of outcome using povidone-soaked suture and ordinary suture. In this study, our hypothesis the suture with povidone-soaked will reduce the SSIs rate during closure and it will be assessed on day 10 and day 30 post-operative.
Few measurement are used in detection of SSI based on clinical and biochemical measurement such as signs of inflammation and total white cell count.
Measured: 6 months
Secondary outcomes (2)
Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia
There is association between povidone-soaked suture and ordinary suture in reducing surgical site infection. There is difference of outcome using povidone-soaked suture and ordinary suture. In this study, our hypothesis the suture with povidone-soaked will reduce the SSIs rate during closure and it will be assessed on day 10 and day 30 post-operative.
Few measurement are used in detection of SSI based on clinical and biochemical measurement such as signs of inflammation and total white cell count.
Measured: 6 months
Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia
There is difference in the extent of intervention needed to manage SSIs in wounds closed with povidone-soaked suture and ordinary suture.
This hypothesis measure how far that the management of SSIs whether non-operative or operative treatment is needed.
This is base on antibiotic use, dressing and surgical intervention such as debridement.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start2 Nov 2020
- Primary completion30 May 2021
- Study completion2 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy Povidone Soaked Suture in Reducing Surgical Site InfectionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- randomized control trial, double blind
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SITI HAFZAN, Universiti Sains Malaysia
- Investigators
- SITI HAFZAN ABD KARIM, MD, Principal investigator, UNIVERSITI SAINS MALAYSIA- HEALTH CAMPUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090176
- Sponsor's protocol ID
- fz03
- Status last verified
- Oct 2021
- First submitted
- 14 Sep 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: Povidone-soaked Sutures Versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia
- ClinicalTrials.gov ID
- NCT05090176
- Acronym / sponsor ID
- fz03
- Keywords
- suture, povidone, surgical site infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 2 Nov 2021 (estimated)
- First posted
- 22 Oct 2021 (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.
To determine efficacy of using 3 minutes povidone-soaked suture in reducing surgical site infection during wound closure in elective surgery.
Detailed description
Participant recruitment and randomisation based on eligibility based on CONSORT.
Patient will get either package A or B which determine whether they are getting povidone-soaked suture or ordinary suture during wound closure.
Postoperative, follow up on D10 and D30 of patient well being and signs and symptoms of surgical site infection
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized control trial, double blind
| Arm | Type | Receives |
|---|---|---|
| povidone-soaked suture | Experimental | Other: povidone-soaked sutureThe patient is randomized, those with povidone-soaked suture group will be prepared for povidone-soaked suture during wound closure. The absorbable suture will be soaked into povidone for 3 mins before the wound closure. |
| ordinary suture | Active comparator | Other: ordinary suturethe patient is randomized, those with ordinary suture group will proceed with wound closure as usual manner following the standard practice. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than 12 years old
- Clean surgery or Clean- contaminated surgery
- Elective surgery
Key exclusion criteria (7 listed)
- Age less than 12 years old
- Contaminated wound
- Dirty wound
- Allergy to povidone-iodine
- Pregnant
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-soaked suturesuture soak with povidone solution for 3 mins | Other | povidone-soaked suture |
| ordinary suturesuture no need to soak with povidone solution | Other | ordinary suture |
Primary outcome
Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia
Time frame: 6 months
There is difference of outcome using povidone-soaked suture and ordinary suture. In this study, our hypothesis the suture with povidone-soaked will reduce the SSIs rate during closure and it will be assessed on day 10 and day 30 post-operative. Few measurement are used in detection of SSI based on clinical and biochemical measurement such as signs of inflammation and total white cell count.
2 secondary outcomes
Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia
Time frame: 6 months
Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
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.
SITI HAFZAN ABD KARIM, MD principal investigator
UNIVERSITI SAINS MALAYSIA- HEALTH CAMPUS
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-soaked suture and ordinary suture in people with Efficacy Povidone Soaked Suture in Reducing Surgical Site Infection, run by Universiti Sains Malaysia at 1 site in Malaysia.
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 3 inclusion and 7 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 22 Oct 2021. 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 Malaysia. 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?
Results are not available in the source record.
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?
Povidone-soaked Sutures versus Ordinary Sutures for Reducing Surgical Site Infection: Randomize Control Trial Study in General Surgery Cases of Hospital Universiti Sains Malaysia (time frame: 6 months). 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 Oct 2021.