Wound of KneePICONCT02064270
Study to Compare Negative Pressure Wound Therapy or Standard Dressings After Orthopedic Surgery
A study testing Single-Use Negative Pressure Wound Therapy and Standard postsurgical dressings in people with Wound of Knee and Wound of Hip, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The aim of this study is to assess the prevention of incision healing complications in patients undergoing Total Knee Arthroscopy (TKA) and Total Hip Arthroscopy (THA) treated with either Single-Use Incisional NPWT (Negative Pressure Wound Therapy), or standard of care dressings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound of Knee, Wound of Hip
- What is being tested?
- Single-Use Negative Pressure Wound Therapy and Standard postsurgical dressings
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 526 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 7 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Patient ≥18 years old
- - Male or non-pregnant females
- - Patient is scheduled to have a surgical procedure for Total Knee Arthroplasty or Total Hip Arthroplasty (Primary or Revision Procedure)
- - The patient is able to understand the trial and is willing to consent to the trial
Who cannot join
- - Patients who in the opinion of the investigator may not complete the study for any reason
- - Patients with a known history of poor compliance with medical treatment
- - Patients who have participated in this trial previously and who were withdrawn
- - Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
- - Patients not capable of obtaining a standardized digital picture at day 7 (1 week from surgery), and submitting it to the site.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Health System
Columbia, Missouri, 65212
About this study
Official title: Prospective Randomized, Controlled Study to Assess Prevention of Incision Healing Complications in Patients Undergoing Total Knee or Hip Arthroplasty, Treated With Either Negative Pressure Wound Therapy or Standard Dressings.
The aim of this study is to assess the prevention of incision healing complications in patients undergoing Total Knee Arthroscopy (TKA) and Total Hip Arthroscopy (THA) treated with either Single-Use Incisional NPWT (Negative Pressure Wound Therapy), or standard of care dressings.
Read the detailed description
Most surgical wounds heal by primary intention, meaning the wound edges are brought together, or approximated, by some sort of mechanical means (sutures, staples, paper tape, surgical glue or adhesive strips) to heal with minimal scar formation. National clinical guidelines recommend that incisions are covered with a postsurgical cover dressing, for up to a period of 48 hours, to help control postoperative bleeding, absorb exudate, provide mechanical protection, help to reduce edema and provide protection from exogenous sources. Multiple patient comorbidities, environmental factors and the type and length of surgery may elevate certain groups of patients into a higher level of risk of developing a post-surgical complication: calling for a higher degree of vigilance and postsurgical intervention. Surgical complications include; wound dehiscence, infection (deep or superficial), hematomas, seromas, tissue necrosis and delayed incision healing. Complication rates can range from 19% in patients requiring open reduction and internal fixation (ORIF) of tibial plateau, pilon and calcaneus fractures up to 50% in high energy trauma wounds. These complications can have a high degree of morbidity for the patient and further sequelae may result in additional surgical procedures or revisions, a lower functional status for the patient, an increased in length of hospital stay (LOS) and a higher cost for the healthcare provider.
Traditional NPWT has been shown to be an effective adjunct therapy in the treatment of acute and chronic wounds, but the emergence of incisional NPWT (iNPWT) and supporting evidence is growing momentum. In vitro studies have shown that iNPWT may help to improve the stimulation of blood flow, help manage exudate, help to reduce edema, provide a mechanical and "splinting" effect on the incision and provide mechanical protection from the environment. Its impact on the prevention or reduction of post-surgical incision complications is still in its infancy, but recent studies have been encouraging and have demonstrated a statistically significant reduction in infection and dehiscence in patients considered as high-risk following severe skeletal trauma.
The aim of this study is to assess the prevention of incision healing complications in patients undergoing TKA and THA treated with either Single-Use Incisional NPWT compared to standard of care dressings.
- Conditions
- Wound of Knee, Wound of Hip
- Being tested
- Single-Use Negative Pressure Wound Therapy, Standard postsurgical dressings
- Keywords
- incision care, Total Hip Arthroplasty, Total Knee Arthroplasty, Knee surgery, Hip surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Use Negative Pressure Wound TherapyDevice
Also called NPWT, PICO
Application of PICO Single-Use Negative Pressure Wound Therapy
Standard postsurgical dressingsDevice
Use of Standard postsurgical dressings
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Active comparator | Single-Use Negative Pressure Wound Therapy (NPWT) Receives: Device: Single-Use Negative Pressure Wound Therapy |
| Standard dressings | Active comparator | Standard postsurgical dressings Receives: Device: Standard postsurgical dressings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incision Appearance Based on VAS (Incision Healing Assessment Form)
Visual Analog Pain Scale (VAS): PICO Study Incision Healing Assessment Form. Used to represent the assessment of incision healing based on in-person visual appearance, or appearance based on standard digital photograph. This number is reported as a total score on a 0-100 scale, with 0 being poor incision healing and 100 being excellent incision healing.
Measured: 35 days (+/- 14 days)
Secondary outcomes (5)
Drainage Amount
Incision Drainage:
- None
- Slight (barely noticed)
- Moderate (significant amount, but did not have to change dressing)
- Extensive (had to change dressing)
Measured: 35 days (+/- 14 days)
User-friendliness for Patient
User-Friendliness of PICO device:
- Easy to use (no difficulties, no instruction needed)
- Slightly difficult (needed instruction)
- Minor difficulties (but able to use effectively)
- Difficult (not able to use effectively)
Measured: 7 days
Number of Participants With Complications
Complications experienced by the subject within the study period time-frame will be recorded.
Measured: 35 days (+/- 14 days)
Return to the Operating Room
Information regarding the subject returning to the operating room within the research study time-frame will be recorded.
Measured: 35 days (+/- 14 days)
Need for Antibiotics
The need for additional antibiotics will be recorded.
Measured: 35 days (+/- 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startMar 2014
- Primary completion7 Sep 2017
- Study completion7 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wound of KneeStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Masking
- None (open label)
- Enrolment
- 526 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Principal investigator, James Stannard, University of Missouri-Columbia
- Investigators
- James P Stannard, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02064270
- Sponsor's protocol ID
- 1208434
- Acronym
- PICO
- Status last verified
- Apr 2018
- First submitted
- 6 Feb 2014
- Last updated
- 17 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized, Controlled Study to Assess Prevention of Incision Healing Complications in Patients Undergoing Total Knee or Hip Arthroplasty, Treated With Either Negative Pressure Wound Therapy or Standard Dressings.
- ClinicalTrials.gov ID
- NCT02064270
- Acronym / sponsor ID
- PICO / 1208434
- Conditions
- Wound of Knee, Wound of Hip
- Keywords
- incision care, Total Hip Arthroplasty, Total Knee Arthroplasty, Knee surgery, Hip surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 526 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- Mar 2014
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Posted 17 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the prevention of incision healing complications in patients undergoing Total Knee Arthroscopy (TKA) and Total Hip Arthroscopy (THA) treated with either Single-Use Incisional NPWT (Negative Pressure Wound Therapy), or standard of care dressings.
Detailed description
Most surgical wounds heal by primary intention, meaning the wound edges are brought together, or approximated, by some sort of mechanical means (sutures, staples, paper tape, surgical glue or adhesive strips) to heal with minimal scar formation. National clinical guidelines recommend that incisions are covered with a postsurgical cover dressing, for up to a period of 48 hours, to help control postoperative bleeding, absorb exudate, provide mechanical protection, help to reduce edema and provide protection from exogenous sources. Multiple patient comorbidities, environmental factors and the type and length of surgery may elevate certain groups of patients into a higher level of risk of developing a post-surgical complication: calling for a higher degree of vigilance and postsurgical intervention. Surgical complications include; wound dehiscence, infection (deep or superficial), hematomas, seromas, tissue necrosis and delayed incision healing. Complication rates can range from 19% in patients requiring open reduction and internal fixation (ORIF) of tibial plateau, pilon and calcaneus fractures up to 50% in high energy trauma wounds. These complications can have a high degree of morbidity for the patient and further sequelae may result in additional surgical procedures or revisions, a lower functional status for the patient, an increased in length of hospital stay (LOS) and a higher cost for the healthcare provider.
Traditional NPWT has been shown to be an effective adjunct therapy in the treatment of acute and chronic wounds, but the emergence of incisional NPWT (iNPWT) and supporting evidence is growing momentum. In vitro studies have shown that iNPWT may help to improve the stimulation of blood flow, help manage exudate, help to reduce edema, provide a mechanical and "splinting" effect on the incision and provide mechanical protection from the environment. Its impact on the prevention or reduction of post-surgical incision complications is still in its infancy, but recent studies have been encouraging and have demonstrated a statistically significant reduction in infection and dehiscence in patients considered as high-risk following severe skeletal trauma.
The aim of this study is to assess the prevention of incision healing complications in patients undergoing TKA and THA treated with either Single-Use Incisional NPWT compared to standard of care dressings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Active comparator | Device: Single-Use Negative Pressure Wound TherapySingle-Use Negative Pressure Wound Therapy (NPWT) |
| Standard dressings | Active comparator | Device: Standard postsurgical dressingsStandard postsurgical dressings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - Patient ≥18 years old
- - Male or non-pregnant females
- - Patient is scheduled to have a surgical procedure for Total Knee Arthroplasty or Total Hip Arthroplasty (Primary or Revision Procedure)
- - The patient is able to understand the trial and is willing to consent to the trial
Key exclusion criteria (5 listed)
- - Patients who in the opinion of the investigator may not complete the study for any reason
- - Patients with a known history of poor compliance with medical treatment
- - Patients who have participated in this trial previously and who were withdrawn
- - Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
- - Patients not capable of obtaining a standardized digital picture at day 7 (1 week from surgery), and submitting it to the site.
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 |
|---|---|---|
| Single-Use Negative Pressure Wound TherapyAlso: NPWT, PICOApplication of PICO Single-Use Negative Pressure Wound Therapy | Device | Negative Pressure Wound Therapy |
| Standard postsurgical dressingsUse of Standard postsurgical dressings | Device | Standard dressings |
Primary outcome
Incision Appearance Based on VAS (Incision Healing Assessment Form)
Time frame: 35 days (+/- 14 days)
Visual Analog Pain Scale (VAS): PICO Study Incision Healing Assessment Form. Used to represent the assessment of incision healing based on in-person visual appearance, or appearance based on standard digital photograph. This number is reported as a total score on a 0-100 scale, with 0 being poor incision healing and 100 being excellent incision healing.
5 secondary outcomes
Drainage Amount
Time frame: 35 days (+/- 14 days)
User-friendliness for Patient
Time frame: 7 days
Number of Participants With Complications
Time frame: 35 days (+/- 14 days)
Return to the Operating Room
Time frame: 35 days (+/- 14 days)
Need for Antibiotics
Time frame: 35 days (+/- 14 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
James P Stannard, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Use Negative Pressure Wound Therapy and Standard postsurgical dressings in people with Wound of Knee and Wound of Hip, run by University of Missouri-Columbia 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 5 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 Apr 2018. 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?
Yes. Results are posted in the registry (first posted 17 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incision Appearance Based on VAS (Incision Healing Assessment Form) (time frame: 35 days (+/- 14 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 17 Apr 2018.