Knee ArthropathyNCT06181097
Routine Use of Negative Pressure Wound Therapy THR TKR RCT
A study testing negative pressure wound therapy and standard dressing in people with Knee Arthropathy and Hip Arthropathy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Negative pressure wound therapy (NPWT) for post total joint arthroplasty incisions has demonstrated benefits in reducing wound complications. A prospective randomized trial will be conducted including 40 patients who will undergo total knee and total hip arthroplasty. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Arthropathy, Hip Arthropathy, Negative Pressure Wound Therapy
- What is being tested?
- negative pressure wound therapy and standard dressing
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteHong Kong
- Study dates
- 11 Dec 2023to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing total knee or total hip arthroplasty at Prince of Wales Hospital, Hong Kong.
Who cannot join
- Patients using steroid, or other immune modulators that is known to affect wound healing, prior surgery to the knee or hip, skin condition such as eczema that would result in poor healing or widen scars, patients with a known significant history of hypertrophic scarring or keloid.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong
Hong Kong
Michael Tim-yun Ong, 26364171, michael.ong@cuhk.edu.hk
About this study
Official title: Routine Use of Negative Pressure Wound Therapy in Primary Hip and Knee Arthroplasties; a Randomized Controlled Trial
Negative pressure wound therapy (NPWT) for post total joint arthroplasty incisions has demonstrated benefits in reducing wound complications. A prospective randomized trial will be conducted including 40 patients who will undergo total knee and total hip arthroplasty. The number of wound complications within 21 days will be recorded. As well, the aesthetic appearance and quality of scarring of the scar will be assessed.
- Being tested
- negative pressure wound therapy, standard dressing
- Keywords
- Knee Arthropathy, Hip Arthropathy, TKR, THR, Wound therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
negative pressure wound therapyDevice
The intervention group will have layered closure with a 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and a 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. The Smith \& Nephew PICO dressing will be chosen as it is versatile with various size options, and the small suction pump is would not causing much problems to patient mobility.
standard dressingOther
The standard dressing group will have layered closure with a 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and a 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. The same PICO dressing will be applied, but without the suction.
| Study group | Role | What they receive |
|---|---|---|
| negative pressure wound therapy | Experimental | Both groups will have layered closure with 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. For the NPWT group, the Smith \& Nephew PICO dressing will be chosen as it is versatile with various size options, and the small suction pump is would not causing much problems to patient mobility. For the standard dressing group, the same PICO dressing will be applied, but without the suction. Receives: Device: negative pressure wound therapy |
| standard dressing | Active comparator | Both groups will have layered closure with 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. For the NPWT group, the Smith \& Nephew PICO dressing will be chosen as it is versatile with various size options, and the small suction pump is would not causing much problems to patient mobility. For the standard dressing group, the same PICO dressing will be applied, but without the suction. Receives: Other: standard dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound-related complications
Recurrence of wound exudate, surgical site infections, dressing-related issues, readmission to hospital and any further surgical interventions will be documented by the research personnel status at 21 days after the index operation.
Measured: 21 days after surgery
Secondary outcomes (2)
Patient Scale and Observer Scale (POSAS)
The POSAS has category boxes to core nominal parameters, for example colour of the scar. Each item of both scales have a 10-point score, with 10 indicating the worse imaginable scar or sensation and 1 corresponding to normal scar or skin (normal pigmentation, no itching, etc.). The total score of both scale is calculated by summing up the score of each of the six items and ranges from 6 to 60.
Measured: 21 days after surgery
Multi-category visual analogue scale
The multi-category visual analogue scale (VAS) is a photograph based scale derived from evaluating standardised digital photographs in four categories (pigmentation, vascularity, acceptability and patient comfort) plus contour. The individual scores are added to give a single overall score ranging from "excellent" to "poor"
Measured: 21 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start11 Dec 2023
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be recruited and randomized to either NPWT and standard dressing.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Tim-Yun Michael ONG, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181097
- Sponsor's protocol ID
- 2023.208
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Use of Negative Pressure Wound Therapy in Primary Hip and Knee Arthroplasties; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06181097
- Acronym / sponsor ID
- 2023.208
- Keywords
- Knee Arthropathy, Hip Arthropathy, TKR, THR, Wound therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 26 Dec 2023 (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.
Negative pressure wound therapy (NPWT) for post total joint arthroplasty incisions has demonstrated benefits in reducing wound complications. A prospective randomized trial will be conducted including 40 patients who will undergo total knee and total hip arthroplasty. The number of wound complications within 21 days will be recorded. As well, the aesthetic appearance and quality of scarring of the scar will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible patients will be recruited and randomized to either NPWT and standard dressing.
| Arm | Type | Receives |
|---|---|---|
| negative pressure wound therapy | Experimental | Device: negative pressure wound therapyBoth groups will have layered closure with 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. For the NPWT group, the Smith \& Nephew PICO dressing will be chosen as it is versatile with various size options, and the small suction pump is would not causing much problems to patient mobility. For the standard dressing group, the same PICO dressing will be applied, but without the suction. |
| standard dressing | Active comparator | Other: standard dressingBoth groups will have layered closure with 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. For the NPWT group, the Smith \& Nephew PICO dressing will be chosen as it is versatile with various size options, and the small suction pump is would not causing much problems to patient mobility. For the standard dressing group, the same PICO dressing will be applied, but without the suction. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing total knee or total hip arthroplasty at Prince of Wales Hospital, Hong Kong.
Key exclusion criteria (1 listed)
- Patients using steroid, or other immune modulators that is known to affect wound healing, prior surgery to the knee or hip, skin condition such as eczema that would result in poor healing or widen scars, patients with a known significant history of hypertrophic scarring or keloid.
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 therapyThe intervention group will have layered closure with a 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and a 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. The Smith \& Nephew PICO dressing will be chosen as it is versatile with various size options, and the small suction pump is would not causing much problems to patient mobility. | Device | negative pressure wound therapy |
| standard dressingThe standard dressing group will have layered closure with a 2-O Vicryl (polyglactin 910) braided suture for the subcutaneous layers and a 3-O Stratafix knotless barbed suture for the subcuticular layer. Fixation strips (STERI-Strip, 3M) would then be applied to the entire length of the wound. The same PICO dressing will be applied, but without the suction. | Other | standard dressing |
Primary outcome
Wound-related complications
Time frame: 21 days after surgery
Recurrence of wound exudate, surgical site infections, dressing-related issues, readmission to hospital and any further surgical interventions will be documented by the research personnel status at 21 days after the index operation.
2 secondary outcomes
Patient Scale and Observer Scale (POSAS)
Time frame: 21 days after surgery
Multi-category visual analogue scale
Time frame: 21 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing negative pressure wound therapy and standard dressing in people with Knee Arthropathy and Hip Arthropathy, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Dec 2023. 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 Hong Kong. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Tim-Yun Ong (26364171, michael.ong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound-related complications (time frame: 21 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 29 Dec 2023.