Prosthetic Joint InfectionNCT00829556
Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing Total Joint Replacement
A study testing Integuseal in people with Prosthetic Joint Infection and Surgical Skin Infection, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
This study is being conducted to investigate the potential benefits of using a special type of fluid that can be applied to the skin (Integuseal) in addition to standard surgical skin preparation in patients undergoing total hip replacement (THA) or total knee replacement (TKA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Prosthetic Joint Infection, Surgical Skin Infection
- What is being tested?
- Integuseal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Sep 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are able and willing to provide informed consent;
- Male and non-pregnant, non-lactating, female subjects who are willing to practice effective means of contraception or postmenopausal/surgically sterilized female subjects, between the ages of 18-80 years old, of any ethnic origin.
- Subjects deemed able to comply with study schedule visits, procedures and medications as specified by the protocol.
- Subjects undergoing elective THA or TKA procedures.
- Subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination.
Who cannot join
- Subjects undergoing revision, hemiarthroplasty, or bilateral THA or TKA
- Subjects undergoing non-elective THA or TKA procedures.
- Pregnant or lactating females or females of childbearing potential not practicing an effective method of contraception.
- Subjects with known allergies to iodine and/or chlorhexidine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Center, Randomized Trial to Study the Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing
This study is being conducted to investigate the potential benefits of using a special type of fluid that can be applied to the skin (Integuseal) in addition to standard surgical skin preparation in patients undergoing total hip replacement (THA) or total knee replacement (TKA). Integuseal is supposed to lock down the skin bacteria and reduce skin infection and other problems. This study will investigate whether Integuseal is effective in reducing persistent wound drainage when used in addition to standard surgical skin preparation for total hip arthroplasty (THA) or total knee replacement (TKA).
- Being tested
- Integuseal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntegusealDevice
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: Integuseal |
| 2 | No intervention | Standard Surgical skin preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study will be to determine the incidence of postoperative wound drainage during hospital stay when adding Integuseal to the normal surgical skin preparation.
Measured: Total joint replacement to discharge from hospital
Secondary outcomes (3)
To evaluate the effect of using Integuseal on the length of hospital stay after THA or TKA.
Measured: Total joint replacement to discharge from hospital
To evaluate the effect of using Integuseal on the incidence of surgical site infection (SSI).
Measured: 6 weeks
To evaluate the effect of using Integuseal on the incidence of revision or re-admission after undergoing THA or TKA
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Joint 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Collaborators
- Kimberly-Clark Corporation
- Investigators
- Javad Parvizi, MD, FRCS, Principal investigator, Rothman Institute Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829556
- Sponsor's protocol ID
- RIFJPAR 08-01
- Status last verified
- Dec 2009
- First submitted
- 26 Jan 2009
- Last updated
- 21 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center, Randomized Trial to Study the Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing
- ClinicalTrials.gov ID
- NCT00829556
- Acronym / sponsor ID
- RIFJPAR 08-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Collaborators
- Kimberly-Clark Corporation
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Jan 2009 (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.
This study is being conducted to investigate the potential benefits of using a special type of fluid that can be applied to the skin (Integuseal) in addition to standard surgical skin preparation in patients undergoing total hip replacement (THA) or total knee replacement (TKA). Integuseal is supposed to lock down the skin bacteria and reduce skin infection and other problems. This study will investigate whether Integuseal is effective in reducing persistent wound drainage when used in addition to standard surgical skin preparation for total hip arthroplasty (THA) or total knee replacement (TKA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Integuseal |
| 2 | No intervention | –Standard Surgical skin preparation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects who are able and willing to provide informed consent;
- Male and non-pregnant, non-lactating, female subjects who are willing to practice effective means of contraception or postmenopausal/surgically sterilized female subjects, between the ages of 18-80 years old, of any ethnic origin.
- Subjects deemed able to comply with study schedule visits, procedures and medications as specified by the protocol.
- Subjects undergoing elective THA or TKA procedures.
- Subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination.
Key exclusion criteria (4 listed)
- Subjects undergoing revision, hemiarthroplasty, or bilateral THA or TKA
- Subjects undergoing non-elective THA or TKA procedures.
- Pregnant or lactating females or females of childbearing potential not practicing an effective method of contraception.
- Subjects with known allergies to iodine and/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 |
|---|---|---|
| Integuseal | Device | 1 |
Primary outcome
The primary endpoint of the study will be to determine the incidence of postoperative wound drainage during hospital stay when adding Integuseal to the normal surgical skin preparation.
Time frame: Total joint replacement to discharge from hospital
3 secondary outcomes
To evaluate the effect of using Integuseal on the length of hospital stay after THA or TKA.
Time frame: Total joint replacement to discharge from hospital
To evaluate the effect of using Integuseal on the incidence of surgical site infection (SSI).
Time frame: 6 weeks
To evaluate the effect of using Integuseal on the incidence of revision or re-admission after undergoing THA or TKA
Time frame: 6 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 21 Dec 2009.
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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.
Javad Parvizi, MD, FRCS principal investigator
Rothman Institute Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integuseal in people with Prosthetic Joint Infection and Surgical Skin Infection, run by Rothman Institute Orthopaedics at 1 site in United States.
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 5 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 21 Dec 2009. 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 United States. 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?
The primary endpoint of the study will be to determine the incidence of postoperative wound drainage during hospital stay when adding Integuseal to the normal surgical skin preparation. (time frame: Total joint replacement to discharge from hospital). 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 21 Dec 2009.