Arthroplasty, Hip ReplacementNCT03393819
Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery
A study testing DuraPrep and ChloraPrep in people with Arthroplasty, Hip Replacement and Infection, Postoperative Wound, run by Lakehead University.
Trial summary
This study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep (iodine-alcohol) at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Hip Replacement, Infection, Postoperative Wound
- What is being tested?
- DuraPrep and ChloraPrep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 29 Oct 2014to 6 Apr 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has consented for primary total hip arthroplasty by any of the following orthopaedic surgeons: Drs. Kurt Droll, Dave Puskas or Claude Cullinan
- Are capable of providing their own consent
- Are able to adequately communicate in English to undergo informed consent
- Has provided written, informed consent for the study
Who cannot join
- Previous hip arthroplasty
- Evidence of an open wound at the incision site
- Evidence of an abrasion in the vicinity of the planned incision
- Evidence of an active infection at or near the surgical site
- Evidence of an active infection elsewhere in the body
- Are chronically immunosuppressed e.g. transplant
- Is deemed not suitable for the study in the opinion of an investigator
About this study
This study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep (iodine-alcohol) at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation.
Read the detailed description
Post-operative infections, although rare, can lead to significant patient morbidity and cost. A potential risk factor for the development of post-operative wound infection is the amount of bacterial skin flora present at the operative site at the time of surgery. Therefore, the use of an effective anti-microbial preoperative skin-preparation solution is essential in preventing the contamination of the surgical site and in turn the surgical wound.
Several different types of anti-microbial skin preparation solutions are presently used pre-operatively. However, there is currently no consensus on which solution is superior. Previous studies have investigated the efficacy of commonly used solutions in the shoulder, foot and spine, however the bacterial flora from these areas are likely different from the hip region. Thus the findings in the literature are not necessarily applicable to surgery involving the hip.
Because of the potentially devastating consequences of a surgical wound infection, ensuring effective skin preparation prior to surgery is critical. Therefore the identification of a superior skin-preparation solution for the elimination of bacterial pathogens, specific to the hip region, could potentially have considerable impact on the clinical care of patients undergoing hip arthroplasty surgery.
This study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep (iodine-alcohol), at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation.The primary outcome is as follows: positive culture rates of residual bacteria following surgical skin preparation. Secondary outcomes that will be evaluated is culture rates post-surgery (following skin closure) and acute (within 3 months) post-operative wound complications.
- Being tested
- DuraPrep, ChloraPrep
- Keywords
- antimicrobial skin solution, skin preparation
- 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.
DuraPrepDrug
Also called Iodine Povacrylex and Isopropyl Alcohol
DuraPrep surgical solution
ChloraPrepDrug
Also called chlorhexidine-alcohol
ChloraPrep surgical solution
| Study group | Role | What they receive |
|---|---|---|
| Duraprep Surgical Solution | Experimental | Surgical site (hip) is prepared with Duraprep (iodine-alcohol) prior to surgery according to package instructions. Receives: Drug: DuraPrep |
| Chloraprep Surgical Solution | Experimental | Surgical site (hip) is prepared with Chloraprep (chlorhexidine-alcohol) prior to surgery according to package instructions. Receives: Drug: ChloraPrep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-preparation skin swab
bacterial culture rates following surgical skin preparation
Measured: 4 minutes post-skin preparation
Secondary outcomes (2)
Post-operative skin swab
bacterial culture rates following surgery
Measured: immediately after closure of the incision, before drape is removed from operative site
Post-operative wound complications
wound complications at follow-up
Measured: 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start29 Oct 2014
- Primary completion7 Jan 2016
- Study completion6 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Hip ReplacementStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakehead University
- Sponsor type
- University, hospital or other
- Collaborators
- Thunder Bay Regional Health Sciences Centre
- Responsible party
- Principal investigator, Kurt Droll, Lakehead University
- Investigators
- Kurt Droll, MD, Principal investigator, TBRHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393819
- Sponsor's protocol ID
- RP-002-01072013
- Status last verified
- Jun 2019
- First submitted
- 3 Jan 2018
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- 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 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Surgical Skin Preparation Solutions in Hip Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT03393819
- Acronym / sponsor ID
- RP-002-01072013
- Keywords
- antimicrobial skin solution, skin preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Lakehead UniversityUniversity, hospital or other
- Collaborators
- Thunder Bay Regional Health Sciences Centre
- Study start
- 29 Oct 2014 (actual)
- Primary completion
- 7 Jan 2016 (actual)
- Study completion
- 6 Apr 2016 (actual)
- First posted
- 9 Jan 2018 (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 study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep (iodine-alcohol) at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation.
Detailed description
Post-operative infections, although rare, can lead to significant patient morbidity and cost. A potential risk factor for the development of post-operative wound infection is the amount of bacterial skin flora present at the operative site at the time of surgery. Therefore, the use of an effective anti-microbial preoperative skin-preparation solution is essential in preventing the contamination of the surgical site and in turn the surgical wound.
Several different types of anti-microbial skin preparation solutions are presently used pre-operatively. However, there is currently no consensus on which solution is superior. Previous studies have investigated the efficacy of commonly used solutions in the shoulder, foot and spine, however the bacterial flora from these areas are likely different from the hip region. Thus the findings in the literature are not necessarily applicable to surgery involving the hip.
Because of the potentially devastating consequences of a surgical wound infection, ensuring effective skin preparation prior to surgery is critical. Therefore the identification of a superior skin-preparation solution for the elimination of bacterial pathogens, specific to the hip region, could potentially have considerable impact on the clinical care of patients undergoing hip arthroplasty surgery.
This study will assess the efficacy of two of the most commonly used surgical skin-preparation solutions: Chloraprep (chlorhexidine-alcohol) and Duraprep (iodine-alcohol), at eliminating bacteria from the hip site by evaluating the residual bacteria present following surgical skin-preparation.The primary outcome is as follows: positive culture rates of residual bacteria following surgical skin preparation. Secondary outcomes that will be evaluated is culture rates post-surgery (following skin closure) and acute (within 3 months) post-operative wound complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Duraprep Surgical Solution | Experimental | Drug: DuraPrepSurgical site (hip) is prepared with Duraprep (iodine-alcohol) prior to surgery according to package instructions. |
| Chloraprep Surgical Solution | Experimental | Drug: ChloraPrepSurgical site (hip) is prepared with Chloraprep (chlorhexidine-alcohol) prior to surgery according to package instructions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Has consented for primary total hip arthroplasty by any of the following orthopaedic surgeons: Drs. Kurt Droll, Dave Puskas or Claude Cullinan
- Are capable of providing their own consent
- Are able to adequately communicate in English to undergo informed consent
- Has provided written, informed consent for the study
Key exclusion criteria (7 listed)
- Previous hip arthroplasty
- Evidence of an open wound at the incision site
- Evidence of an abrasion in the vicinity of the planned incision
- Evidence of an active infection at or near the surgical site
- Evidence of an active infection elsewhere in the body
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 |
|---|---|---|
| DuraPrepAlso: Iodine Povacrylex and Isopropyl AlcoholDuraPrep surgical solution | Drug | Duraprep Surgical Solution |
| ChloraPrepAlso: chlorhexidine-alcoholChloraPrep surgical solution | Drug | Chloraprep Surgical Solution |
Primary outcome
Post-preparation skin swab
Time frame: 4 minutes post-skin preparation
bacterial culture rates following surgical skin preparation
2 secondary outcomes
Post-operative skin swab
Time frame: immediately after closure of the incision, before drape is removed from operative site
Post-operative wound complications
Time frame: 3 months post-surgery
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 1 Jul 2019.
- Individual participant dataSharing planned: No
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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.
Kurt Droll, MD principal investigator
TBRHSC
Questions about this trial
What is this clinical trial studying?
A study testing DuraPrep and ChloraPrep in people with Arthroplasty, Hip Replacement and Infection, Postoperative Wound, run by Lakehead 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 4 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: finished, as of the sponsor's last update on 1 Jul 2019. 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.
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?
Post-preparation skin swab (time frame: 4 minutes post-skin preparation). 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 1 Jul 2019.