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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Wound Therapy | Active Comparator | Single-Use Negative Pressure Wound Therapy (NPWT) |
|
| Standard dressings | Active Comparator | Standard postsurgical dressings |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-Use Negative Pressure Wound Therapy | Device | Application of PICO Single-Use Negative Pressure Wound Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 35 days (+/- 14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Drainage Amount | Incision Drainage:
| 35 days (+/- 14 days) |
| User-friendliness for Patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James P Stannard, MD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri Health System | Columbia | Missouri | 65212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Negative Pressure Wound Therapy | Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy |
| FG001 | Standard Dressings | Standard postsurgical dressings Standard postsurgical dressings: Use of Standard postsurgical dressings |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Negative Pressure Wound Therapy | Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy |
| BG001 | Standard Dressings |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 35 days (+/- 14 days) |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Negative Pressure Wound Therapy | Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deep Infection Requiring Additional Surgery | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stacee Clawson, Research Manager | University of Missouri, Department of Orthopaedic Surgery | 5738849017 | clawsons@health.missouri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 27, 2017 | Mar 8, 2018 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2016 | Mar 8, 2018 | Prot_SAP_001.pdf |
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| Standard postsurgical dressings | Device | Use of Standard postsurgical dressings |
|
User-Friendliness of PICO device:
| 7 days |
| Number of Participants With Complications | Complications experienced by the subject within the study period time-frame will be recorded. | 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. | 35 days (+/- 14 days) |
| Need for Antibiotics | The need for additional antibiotics will be recorded. | 35 days (+/- 14 days) |
Standard postsurgical dressings
Standard postsurgical dressings: Use of Standard postsurgical dressings
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
Standard postsurgical dressings
Standard postsurgical dressings: Use of Standard postsurgical dressings
|
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| Secondary | Drainage Amount | Incision Drainage:
| Posted | Count of Participants | Participants | 35 days (+/- 14 days) |
|
|
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| Secondary | User-friendliness for Patient | User-Friendliness of PICO device:
| Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Number of Participants With Complications | Complications experienced by the subject within the study period time-frame will be recorded. | Posted | Number | participants | 35 days (+/- 14 days) |
|
|
|
| Secondary | Return to the Operating Room | Information regarding the subject returning to the operating room within the research study time-frame will be recorded. | Posted | Count of Participants | Participants | 35 days (+/- 14 days) |
|
|
|
| Secondary | Need for Antibiotics | The need for additional antibiotics will be recorded. | Posted | Count of Participants | Participants | 35 days (+/- 14 days) |
|
|
|
| 0 |
| 201 |
| 5 |
| 201 |
| 3 |
| 201 |
| EG001 | Standard Dressings | Standard postsurgical dressings Standard postsurgical dressings: Use of Standard postsurgical dressings | 0 | 231 | 6 | 231 | 5 | 231 |
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| Moderate (significant amount, but did not have to |
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| Extensive (had to change dressing) |
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| Difficult |
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