Infection, DrainagePhase 1NCT03321799
Comparison of Negative Pressure Wound Therapy vs. Conventional Dressings for Prevention of Wound Complications After Revision THA
A Phase 1 study testing Negative Pressure Wound Therapy (NPWT) and Sterile Antimicrobial Dressings in people with Infection, Drainage, run by Rush University Medical Center at 1 site in United States.
Trial summary
Wound complications and surgical site infections following revision total joint arthroplasty result in significant morbidity and cost. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection, Drainage
- What is being tested?
- Negative Pressure Wound Therapy (NPWT) and Sterile Antimicrobial Dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2017to 11 Jul 2025
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age undergoing a revision total hip arthroplasty procedure to include:
- Conversion of a prior open hip surgery (i.e. open reduction internal fixation of a proximal femur fracture) to a total hip arthroplasty
- Aseptic revision for a diagnosis of component loosening, osteolysis, or revision procedure for periprosthetic fracture that requires revision of a component of the THA prosthesis (excluded isolated open reduction internal fixation of the fracture or initial placement of a hemi- or total hip arthroplasty)
- Septic revision surgery including irrigation and debridement of a postoperative infection or hematoma, one-stage exchange for acute postoperative infection, explantation and placement of an antibiotic cement spacer
- Reimplantation of a THA following placement of an antibiotic-loaded cement spacer
- The incision can be closed primarily without muscle flaps or skin grafting
- Willingness to undergo randomization and return for all scheduled visits
Who cannot join
- Patients requiring a muscle flap or skin grafting for wound closure
- Pregnant or lactating female
- Known sensitivity to the study product components (adhesives, etc.)
- Allergy to silver
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Negative Pressure Wound Therapy Versus Conventional Dressings for the Prevention of Wound Complications Following Revision Total Hip Arthroplasty: A Prospective, Randomized, Controlled Trial
Wound complications and surgical site infections following revision total joint arthroplasty result in significant morbidity and cost. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with negative pressure wound therapy (NPWT) versus sterile dressings. The investigators hypothesize that the rate of wound complications, infections, and subsequent procedures in patients undergoing revision THA treatment will demonstrate a statistically and clinically relevant decrease when using NPWT versus sterile dressing.
Read the detailed description
Wound complications and surgical site infections (SSI) following revision total joint arthroplasty result in significant morbidity and cost. Persistent incisional drainage following total joint arthroplasty (TJA) has been reported to occur in 1% to 3% of patients. Drainage persisting greater than 48 hours has been reported as a risk factor for the development of an acute periprosthetic joint infection (PJI), with each additional day of wound drainage increasing the infection risk by 29-42%. Consequently, continued wound drainage has been shown to potentially increase the economic burden through longer hospital stays and subsequent surgical procedures. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with NPWT versus sterile dressings. The investigators hypothesize that the rate of wound complications, infections, and subsequent procedures in patients undergoing revision THA treatment will demonstrate a statistically and clinically relevant decrease when using NPWT versus sterile dressing. The investigators will utilize a prospective, randomized, controlled study design to assess the efficacy of negative pressure wound therapy (NPWT) on the rate of wound complications, surgical site infections (SSIs), and reoperations after revision total hip arthroplasty (THA). For 90 days after surgery, the wound complications, including wound dehiscence, prolonged drainage for >7 days postoperatively, hematoma formation, surgical site infection, or periprosthetic joint infection that requires postoperative interventions, and reoperation will be tracked.
- Conditions
- Infection, Drainage
- Being tested
- Negative Pressure Wound Therapy (NPWT), Sterile Antimicrobial Dressings
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound Therapy (NPWT)Device
A computer randomization system will be used on the day of surgery to allocate patients to either the conventional or NPWT dressing. Due to the nature of this study, blinding of patients and surgeons to their allocated cohort will not be possible.
Sterile Antimicrobial DressingsDevice
Control group, current hospital standard.
| Study group | Role | What they receive |
|---|---|---|
| Sterile Antimicrobial Dressings | Active comparator | Control group, current hospital standard. AQUACEL is left in place for 7 days unless it becomes saturated over 50%, which requires a premature dressing change. Receives: Device: Sterile Antimicrobial Dressings |
| Negative pressure wound therapy (NPWT) | Experimental | Experimental group. Negative pressure wound therapy bandage applied intra-operatively by a physician on the treatment team.
The dressing will be removed after 7 days postoperatively, or if the battery power stops earlier. Receives: Device: Negative Pressure Wound Therapy (NPWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound complications
Wound complications within 90 days of a revision total hip arthroplasty include: wound dehiscence, prolonged drainage for >7 days postoperatively, hematoma formation, surgical site infection, or periprosthetic joint infection that requires postoperative interventions (i.e. unplanned office visits, topical application of antibiotics or PO antibiotics, in-office wound debridement or removal of suture material, hematoma aspiration and drainage) or a return to the operating room/reoperation.
Measured: 90 days
Secondary outcomes (2)
Reoperation
Reoperation for a wound complication, surgical site infection, or periprosthetic joint infection within 90 days of the revision THA
Measured: 90 days
Cost comparison
Cost comparison between the NPWT and routine dressing changes within 90 days to include the potential costs of postoperative interventions and reoperation
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start28 Apr 2017
- Primary completion14 Mar 2024
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, DrainageStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Denis Nam, MD, MSc, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321799
- Sponsor's protocol ID
- 16111608
- Status last verified
- Aug 2025
- First submitted
- 23 Oct 2017
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Currently there is no plan to share IPD and if that is decided in the future, that information will be de-identified and in compliant with HIPAA regulations
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Negative Pressure Wound Therapy Versus Conventional Dressings for the Prevention of Wound Complications Following Revision Total Hip Arthroplasty: A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT03321799
- Acronym / sponsor ID
- 16111608
- Conditions
- Infection, Drainage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- 3M
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 26 Oct 2017 (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.
Wound complications and surgical site infections following revision total joint arthroplasty result in significant morbidity and cost. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with negative pressure wound therapy (NPWT) versus sterile dressings. The investigators hypothesize that the rate of wound complications, infections, and subsequent procedures in patients undergoing revision THA treatment will demonstrate a statistically and clinically relevant decrease when using NPWT versus sterile dressing.
Detailed description
Wound complications and surgical site infections (SSI) following revision total joint arthroplasty result in significant morbidity and cost. Persistent incisional drainage following total joint arthroplasty (TJA) has been reported to occur in 1% to 3% of patients. Drainage persisting greater than 48 hours has been reported as a risk factor for the development of an acute periprosthetic joint infection (PJI), with each additional day of wound drainage increasing the infection risk by 29-42%. Consequently, continued wound drainage has been shown to potentially increase the economic burden through longer hospital stays and subsequent surgical procedures. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with NPWT versus sterile dressings. The investigators hypothesize that the rate of wound complications, infections, and subsequent procedures in patients undergoing revision THA treatment will demonstrate a statistically and clinically relevant decrease when using NPWT versus sterile dressing. The investigators will utilize a prospective, randomized, controlled study design to assess the efficacy of negative pressure wound therapy (NPWT) on the rate of wound complications, surgical site infections (SSIs), and reoperations after revision total hip arthroplasty (THA). For 90 days after surgery, the wound complications, including wound dehiscence, prolonged drainage for >7 days postoperatively, hematoma formation, surgical site infection, or periprosthetic joint infection that requires postoperative interventions, and reoperation will be tracked.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sterile Antimicrobial Dressings | Active comparator | Device: Sterile Antimicrobial DressingsControl group, current hospital standard. AQUACEL is left in place for 7 days unless it becomes saturated over 50%, which requires a premature dressing change. |
| Negative pressure wound therapy (NPWT) | Experimental | Device: Negative Pressure Wound Therapy (NPWT)Experimental group. Negative pressure wound therapy bandage applied intra-operatively by a physician on the treatment team. The dressing will be removed after 7 days postoperatively, or if the battery power stops earlier. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients > 18 years of age undergoing a revision total hip arthroplasty procedure to include:
- Conversion of a prior open hip surgery (i.e. open reduction internal fixation of a proximal femur fracture) to a total hip arthroplasty
- Aseptic revision for a diagnosis of component loosening, osteolysis, or revision procedure for periprosthetic fracture that requires revision of a component of the THA prosthesis (excluded isolated open reduction internal fixation of the fracture or initial placement of a hemi- or total hip arthroplasty)
- Septic revision surgery including irrigation and debridement of a postoperative infection or hematoma, one-stage exchange for acute postoperative infection, explantation and placement of an antibiotic cement spacer
- Reimplantation of a THA following placement of an antibiotic-loaded cement spacer
Key exclusion criteria (4 listed)
- Patients requiring a muscle flap or skin grafting for wound closure
- Pregnant or lactating female
- Known sensitivity to the study product components (adhesives, etc.)
- Allergy to silver
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 |
|---|---|---|
| Negative Pressure Wound Therapy (NPWT)A computer randomization system will be used on the day of surgery to allocate patients to either the conventional or NPWT dressing. Due to the nature of this study, blinding of patients and surgeons to their allocated cohort will not be possible. | Device | Negative pressure wound therapy (NPWT) |
| Sterile Antimicrobial DressingsControl group, current hospital standard. | Device | Sterile Antimicrobial Dressings |
Primary outcome
Wound complications
Time frame: 90 days
Wound complications within 90 days of a revision total hip arthroplasty include: wound dehiscence, prolonged drainage for >7 days postoperatively, hematoma formation, surgical site infection, or periprosthetic joint infection that requires postoperative interventions (i.e. unplanned office visits, topical application of antibiotics or PO antibiotics, in-office wound debridement or removal of suture material, hematoma aspiration and drainage) or a return to the operating room/reoperation.
2 secondary outcomes
Reoperation
Time frame: 90 days
Cost comparison
Time frame: 90 days
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 6 Aug 2025.
- Individual participant dataSharing planned: Undecided. Currently there is no plan to share IPD and if that is decided in the future, that information will be de-identified and in compliant with HIPAA regulations
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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.
Denis Nam, MD, MSc principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Negative Pressure Wound Therapy (NPWT) and Sterile Antimicrobial Dressings in people with Infection, Drainage, run by Rush University Medical Center 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 7 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 6 Aug 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Wound complications (time frame: 90 days). 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 6 Aug 2025.