Surgical Wound InfectionNCT03001102
Preoperative Bath in Patients Submitted to Hip Arthroplasty
A study testing 4% Chlorhexidine gluconate, 10% PVPI degermante and Soap without antiseptic in people with Surgical Wound Infection, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms which purpose is verify the effects of nursing intervention preoperative bathing with 4% chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the prevention of surgical site infection (SSI) in… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- 4% Chlorhexidine gluconate, 10% PVPI degermante and Soap without antiseptic
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2015to Mar 2018
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be 18 or older;
- Elective procedure of total hip arthroplasty
- No report of infectious focus at the surgical site
- Know to respond to the clinical signs of a surgical infection or having a person responsible with this ability
- Do not be a nasal carrier of Staphylococcus aureus before surgery
- Have access to fixed or mobile phone
Who cannot join
- Patient treating surgical site infection
- Emergency hip prosthesis surgery or orthopedic trauma
- Nasal carriers of Staphylococcus aureus before surgery
- Previous history of allergic reactions to the products used in the bat
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Bath in Patients Submitted to Hip Arthroplasty: Randomized Clinical Trial
Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms which purpose is verify the effects of nursing intervention preoperative bathing with 4% chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.
Read the detailed description
Despite the recommendation in several guidelines of preoperative bathing with 4% chlorhexidine gluconate as a measure for the prevention of SSI, there is no evidence in the literature that support this practice. The objective of this study is to evaluate the effect of nursing intervention: preoperative bath using 4% chlorhexidine gluconate solutions, 10% povidone iodine degermante or soap without antiseptic for the prevention of SSI in patients undergoing elective hip arthroplasty surgery. The specific objectives are to compare the incidence of SSI in the three interventions, to assess the most effective intervention for the prevention of surgical infection and to estimate the frequency of allergic reactions caused by the use of the solutions. Two intervention groups (4% Chlorhexidine gluconate and PVPI10%) and a control group (without antiseptic soap) composed of 52 patients undergoing hip arthroplasty in each group will be randomized to perform the baths in the period from may 2015 to june 2017. Before the intervention, nasal swabs will be collected of patients to investigate colonization by Staphylococcus aureus.
The expected result is lower ISC rate with the proposed measures.
- Conditions
- Surgical Wound Infection
- Being tested
- 4% Chlorhexidine gluconate, 10% PVPI degermante, Soap without antiseptic
- Keywords
- Preoperative Care, Baths, Chlorhexidine, Soaps, Povidone-Iodine, Arthroplasty, Replacement, Hip, Surgical Wound 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.
4% Chlorhexidine gluconateDevice
Also called HiBiScrub, 4% Chlorhexidine degermante
Cationic biguanide - antimicrobial action rubbing in the skin.
10% PVPI degermanteDevice
Also called Betadine, 10% Povidone iodine degermante
Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.
Soap without antisepticDevice
Also called Non-medicated soap, Soap
Liquid soap with glycerin, neutral pH. Skin cleansing
| Study group | Role | What they receive |
|---|---|---|
| Bathing with 4% Chlorhexidine gluconate | Sham comparator | Two baths with chlorhexidine using precise methods, including to scrubb the whole body with 50mL of undiluted solution, at night before surgery and the morning of surgery. Receives: Device: 4% Chlorhexidine gluconate |
| Bathing with10% PVPI degermante | Experimental | Two baths with PVPI using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery. Receives: Device: 10% PVPI degermante |
| Bathing with soap without antiseptic. | Active comparator | Two baths with soap using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery. Receives: Device: Soap without antiseptic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection of Surgical Site (SSI)
The infections that develop after the surgical procedure
Measured: During the first 90 days after surgery
Secondary outcomes (1)
Allergic reactions
Adverse reaction to a given product
Measured: In the first hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startAug 2015
- Primary completionJan 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Lucia Maciel de Castro Franco, Federal University of Minas Gerais
- Investigators
- Lúcia MC Franco, PhD student, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001102
- Sponsor's protocol ID
- EE-UFMG
- Status last verified
- Feb 2019
- First submitted
- 20 Dec 2016
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The study and the information provided will be confidential and used only for purposes of this research. Disclosure of information will be anonymous and in conjunction with the responses of a group of people, never individually.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Bath in Patients Submitted to Hip Arthroplasty: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03001102
- Acronym / sponsor ID
- EE-UFMG
- Conditions
- Surgical Wound Infection
- Keywords
- Preoperative Care, Baths, Chlorhexidine, Soaps, Povidone-Iodine, Arthroplasty, Replacement, Hip, Surgical Wound Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- Aug 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 22 Dec 2016 (estimated)
- 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.
Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms which purpose is verify the effects of nursing intervention preoperative bathing with 4% chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.
Detailed description
Despite the recommendation in several guidelines of preoperative bathing with 4% chlorhexidine gluconate as a measure for the prevention of SSI, there is no evidence in the literature that support this practice. The objective of this study is to evaluate the effect of nursing intervention: preoperative bath using 4% chlorhexidine gluconate solutions, 10% povidone iodine degermante or soap without antiseptic for the prevention of SSI in patients undergoing elective hip arthroplasty surgery. The specific objectives are to compare the incidence of SSI in the three interventions, to assess the most effective intervention for the prevention of surgical infection and to estimate the frequency of allergic reactions caused by the use of the solutions. Two intervention groups (4% Chlorhexidine gluconate and PVPI10%) and a control group (without antiseptic soap) composed of 52 patients undergoing hip arthroplasty in each group will be randomized to perform the baths in the period from may 2015 to june 2017. Before the intervention, nasal swabs will be collected of patients to investigate colonization by Staphylococcus aureus.
The expected result is lower ISC rate with the proposed measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bathing with 4% Chlorhexidine gluconate | Sham comparator | Device: 4% Chlorhexidine gluconateTwo baths with chlorhexidine using precise methods, including to scrubb the whole body with 50mL of undiluted solution, at night before surgery and the morning of surgery. |
| Bathing with10% PVPI degermante | Experimental | Device: 10% PVPI degermanteTwo baths with PVPI using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery. |
| Bathing with soap without antiseptic. | Active comparator | Device: Soap without antisepticTwo baths with soap using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 18 or older;
- Elective procedure of total hip arthroplasty
- No report of infectious focus at the surgical site
- Know to respond to the clinical signs of a surgical infection or having a person responsible with this ability
- Do not be a nasal carrier of Staphylococcus aureus before surgery
Key exclusion criteria (4 listed)
- Patient treating surgical site infection
- Emergency hip prosthesis surgery or orthopedic trauma
- Nasal carriers of Staphylococcus aureus before surgery
- Previous history of allergic reactions to the products used in the bat
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 |
|---|---|---|
| 4% Chlorhexidine gluconateAlso: HiBiScrub, 4% Chlorhexidine degermanteCationic biguanide - antimicrobial action rubbing in the skin. | Device | Bathing with 4% Chlorhexidine gluconate |
| 10% PVPI degermanteAlso: Betadine, 10% Povidone iodine degermantePolymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin. | Device | Bathing with10% PVPI degermante |
| Soap without antisepticAlso: Non-medicated soap, SoapLiquid soap with glycerin, neutral pH. Skin cleansing | Device | Bathing with soap without antiseptic. |
Primary outcome
Infection of Surgical Site (SSI)
Time frame: During the first 90 days after surgery
The infections that develop after the surgical procedure
1 secondary outcome
Allergic reactions
Time frame: In the first hours after procedure
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 28 Feb 2019.
- Individual participant dataSharing planned: No. The study and the information provided will be confidential and used only for purposes of this research. Disclosure of information will be anonymous and in conjunction with the responses of a group of people, never individually.
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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.
Lúcia MC Franco, PhD student principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4% Chlorhexidine gluconate, 10% PVPI degermante and Soap without antiseptic in people with Surgical Wound Infection, run by Federal University of Minas Gerais 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 6 inclusion and 4 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 28 Feb 2019. 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. Some participants in this study may receive a placebo. 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?
Infection of Surgical Site (SSI) (time frame: During the first 90 days after surgery). 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 28 Feb 2019.