DrainageNCT01097135
Evaluating the Effectiveness of 2 Surgical Skin Preparation Methods in Reducing Surgical Wound Drainage After Total Hip or Knee Replacement
A study testing Duraprep Surgical Solution in people with Drainage, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Surgical skin complications can be costly and could contribute to extended in-patient stay following total joint replacement or even the need for re-admission. If efficacy in reducing the incidence of post-operative wound drainage and, in turn, surgical wound complications can be demonstrated, it may also reduce the… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Drainage
- What is being tested?
- Duraprep Surgical Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2012
- 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, postmenopausal or surgically sterilized female subjects between the ages of 18-80 years old.
- Subjects deemed able to comply with study visit schedule and procedures.
- Subjects undergoing elective total hip arthroplasty or elective total knee arthroplasty.
Who cannot join
- Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or bilateral total hip arthroplasty.
- Subjects undergoing non-elective total joint procedures.
- Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception.
- Subjects with known allergies or previous skin reaction to iodine povacrylex
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized Clinical Study to Evaluate the Efficacy of 2 Surgical Skin Preparations in Reducing Wound Drainage Following Total Joint Arthroplasty
Surgical skin complications can be costly and could contribute to extended in-patient stay following total joint replacement or even the need for re-admission. If efficacy in reducing the incidence of post-operative wound drainage and, in turn, surgical wound complications can be demonstrated, it may also reduce the length of hospital stay and the need for revision surgery or readmission. The aim of this research is to investigate the incidence of post-operative wound drainage following elective total joint arthroplasty using two surgical skin preparation protocols.
- Conditions
- Drainage
- Being tested
- Duraprep Surgical Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duraprep Surgical SolutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Standard surgical skin preparation | No intervention | Not described |
| Standard Surgical Skin Preparation with Duraprep | Active comparator | standard surgical skin prep Receives: Drug: Duraprep Surgical Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to determine the rate of wound drainage following total joint arthroplasty (TJA) until discharge in both treatment groups
Starting on post operative day 1 (the first day following surgery), at the time of the surgical dressings are removed and changed, assessments will be made to determine level of post-operative wound drainage following TJA.
Measured: Up to one year following surgery
Secondary outcomes (6)
The secondary objectives will focus on wound assessment and signs and symptoms of infection from TJA until discharge.
Measured: until hospital discharge
Length of hospital stay
Measured: until hospital discharge
Need for readmission or reoperation for up to 6 weeks following TJA
Measured: 6 weeks post-op
Incidence of surgical skin infection at the first post-operative visit (6 weeks following surgery)
Measured: 6 weeks post-op
Incidence of skin blistering.
Measured: up to one year post-op
Scar cosmesis at the first post-operative visit.
Measured: up to 6 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DrainageStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Principal investigator, Tiffany Morrison, MS, Rothman Institute Orthopaedics
- Investigators
- Javad Parvizi, MD, FRCS, Principal investigator, Rothman Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097135
- Sponsor's protocol ID
- RIFJPAR-10-02
- Status last verified
- Sep 2013
- First submitted
- 30 Mar 2010
- Last updated
- 17 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Clinical Study to Evaluate the Efficacy of 2 Surgical Skin Preparations in Reducing Wound Drainage Following Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT01097135
- Acronym / sponsor ID
- RIFJPAR-10-02
- Conditions
- Drainage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Collaborators
- 3M
- Study start
- Mar 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Apr 2010 (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.
Surgical skin complications can be costly and could contribute to extended in-patient stay following total joint replacement or even the need for re-admission. If efficacy in reducing the incidence of post-operative wound drainage and, in turn, surgical wound complications can be demonstrated, it may also reduce the length of hospital stay and the need for revision surgery or readmission. The aim of this research is to investigate the incidence of post-operative wound drainage following elective total joint arthroplasty using two surgical skin preparation protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard surgical skin preparation | No intervention | – |
| Standard Surgical Skin Preparation with Duraprep | Active comparator | Drug: Duraprep Surgical Solutionstandard surgical skin prep |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who are able and willing to provide informed consent
- Male and non-pregnant, non-lactating, postmenopausal or surgically sterilized female subjects between the ages of 18-80 years old.
- Subjects deemed able to comply with study visit schedule and procedures.
- Subjects undergoing elective total hip arthroplasty or elective total knee arthroplasty.
Key exclusion criteria (4 listed)
- Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or bilateral total hip arthroplasty.
- Subjects undergoing non-elective total joint procedures.
- Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception.
- Subjects with known allergies or previous skin reaction to iodine povacrylex
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 |
|---|---|---|
| Duraprep Surgical Solution | Drug | Standard Surgical Skin Preparation with Duraprep |
Primary outcome
The primary objective of this study is to determine the rate of wound drainage following total joint arthroplasty (TJA) until discharge in both treatment groups
Time frame: Up to one year following surgery
Starting on post operative day 1 (the first day following surgery), at the time of the surgical dressings are removed and changed, assessments will be made to determine level of post-operative wound drainage following TJA.
6 secondary outcomes
The secondary objectives will focus on wound assessment and signs and symptoms of infection from TJA until discharge.
Time frame: until hospital discharge
Length of hospital stay
Time frame: until hospital discharge
Need for readmission or reoperation for up to 6 weeks following TJA
Time frame: 6 weeks post-op
Incidence of surgical skin infection at the first post-operative visit (6 weeks following surgery)
Time frame: 6 weeks post-op
Incidence of skin blistering.
Time frame: up to one year post-op
Scar cosmesis at the first post-operative visit.
Time frame: up to 6 weeks post-op
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 17 Sep 2013.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duraprep Surgical Solution in people with Drainage, 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 4 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 17 Sep 2013. 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 objective of this study is to determine the rate of wound drainage following total joint arthroplasty (TJA) until discharge in both treatment groups (time frame: Up to one year following 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 17 Sep 2013.