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Smith & Nephew are assessing a new investigational single use NPWT system.
Smith & Nephew are assessing a new investigational single use NPWT system. There is a significant amount of clinical evidence to show that NPWT may reduce oedema, increase healing and reduce chance of infection, through maintenance of pressure therapy, in closed incisions. Subjects with abdominal incisions and knee incisions following knee surgery will be recruited to the study and receive NPWT for 7 days. The performance of the system will be logged by the device and acceptability of the device will be assessed by patient and clinician. Safety will be assessed with a 30 day follow up to assess complications and device related events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal | Other | Abdominal surgery type with investigational single use NPWT dressing |
|
| Knee | Other | Knee surgery type with investigational single use NPWT dressing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Negative-Pressure Wound Therapy (NPWT) | Device | Investigational single use disposable negative pressure system. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Negative Pressure Maintenance at Nominal 80 mmHg | Negative pressure maintenance at nominal 80 mmHg assessed as the average of the negative pressure values recorded by the device for Abdominal and Knee surgery types. This data was summarized to show an average negative pressure provided over the treatment duration. | 30 days post-op |
| Dressing Wear Time | Dressing wear time in days as assessed of any unplanned dressing change by Abdominal and Knee surgery type. | 7 days |
| Exudate Management (Occurrence of Exudate Leaks) | Number of participants with occurrence of exudate leaks. Leakage classified as 'Any Leak' (Yes/No) by Abdominal and Knee surgery type. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Surgical Site Infection (SSI) | Number of participants with incidence of Surgical Site Infection (SSI) within 30 days of surgery classified using Centers for Decease Control (CDC) criteria of:
| 30 days |
| Incidence of Surgical Site Complications (SSC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Jeffery | Queen Elizabeth Hospital, Birmingham, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Worthing Hospital | Worthing | West Sussex | BN11 2DH | United Kingdom | ||
| Queen Elizabeth Hospital |
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Enrollment began 12 July 2019 to 01 February 2022 across 8 investigative sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abdominal | Abdominal surgery type with investigational single use NPWT dressing |
| FG001 | Knee | Knee surgery type with investigational single use NPWT dressing |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Full Analysis Set (FAS) population utilized. Participants with Intent-to-Treat (ITT) that included all enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Abdominal | Abdominal surgery type with investigational single use NPWT dressing |
| BG001 | Knee | Knee surgery type with investigational single use NPWT dressing |
| 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 | Negative Pressure Maintenance at Nominal 80 mmHg | Negative pressure maintenance at nominal 80 mmHg assessed as the average of the negative pressure values recorded by the device for Abdominal and Knee surgery types. This data was summarized to show an average negative pressure provided over the treatment duration. | Full Analysis Set (FAS) population included enrolled participants with available data for the surgery type specified. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | 30 days post-op |
|
Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
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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 | Abdominal | Abdominal surgery type with investigational single use NPWT dressing |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peripheral swelling | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
The investigational single use NPWT dressing under investigation within this clinical study has not been submitted for approval and clearance as a medical device within any country
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager Clinical Compliance | Smith+Nephew, Inc | +44 7811 407089 | datasharing.gcs@smith-nephew.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 4, 2021 | Oct 23, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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|
|
Number of participants with incidence of Surgical Site Complications (SSC) within 30 days of surgery categorized as:
|
| 30 days |
| Condition of Peri-Wound Skin Assessed Through Visual Inspection | Condition of peri-wound skin assessed through visual inspection by the investigator at baseline, 7, 14, and 30 days. Number of participants by Abdominal and Knee surgery type where skin was categorized with any condition that applied (i.e., multiple selections possible) from the following criteria:
| Baseline, 7 days, 14 days, and 30 days |
| Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Condition of skin under investigative single use Negative-Pressure Wound Therapy (NPWT) dressing assessed through visual inspection by the investigator at baseline, 7, 14, and 30 days. Number of participants by Abdominal and Knee surgery type where skin was categorized with any condition that applied (i.e., multiple selections possible) from the following criteria:
| Baseline, 7 days, 14 days, and 30 days |
| Wound and Skin Visual Analog Scale (VAS) Score Assessment | Wound and Skin VAS score assessment at 7, 14 and 30 days. Scores range from 0 to 100 with a low score associated to a wound with a major gapping, dehiscence, severe inflammation and/or infection (i.e., poor outcome); and a high correspond to a completely healed wound with no evidence for inflammation (i.e., excellent outcome). | 7 days, 14 days, and 30 days |
| Range of Motion Assessment (ROM) for the Knee | Range of Motion (ROM) assessment for the knee at pre-operative visit, post-operative visit, 7, 14 and 30 days. | 30 days |
| Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score | Level of pain during wear by investigational single use Negative-Pressure Wound Therapy (NPWT) Dressing at day 4 and day 7 assessed using a Visual Analog Scale (VAS) from 0 to 100 where a score of 0 indicated no pain and 100 indicated maximum pain. | 4 days and 7 days |
| Level of Pain at Dressing Removal of the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score | Level of pain during dressing removal by Abdominal and Knee surgery type at treatment discontinuation (up to day 7) assessed using a Visual Analog Scale (VAS) from 0 to 100 where a score of 0 indicated no pain and 100 indicated maximum pain. | 7 days |
| Birmingham |
| United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Queen Elizabeth the Queen Mother Hospital | Margate | United Kingdom |
| North Tyneside General Hospital | North Shields | United Kingdom |
| RJAH Orthopaedic Hospital | Oswestry | United Kingdom |
| Peterborough City Hospital | Peterborough | United Kingdom |
| Torbay Hospital | Torquay | United Kingdom |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Primary | Dressing Wear Time | Dressing wear time in days as assessed of any unplanned dressing change by Abdominal and Knee surgery type. | Full Analysis Set (FAS) population included enrolled participants with available data for the surgery type specified. | Posted | Mean | Standard Deviation | days | 7 days |
|
|
|
| Primary | Exudate Management (Occurrence of Exudate Leaks) | Number of participants with occurrence of exudate leaks. Leakage classified as 'Any Leak' (Yes/No) by Abdominal and Knee surgery type. | Full Analysis Set (FAS) population included enrolled participants with available data for the surgery type specified. | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Incidence of Surgical Site Infection (SSI) | Number of participants with incidence of Surgical Site Infection (SSI) within 30 days of surgery classified using Centers for Decease Control (CDC) criteria of:
| Full Analysis Set (FAS) population included all enrolled participants with available data for the specified assessment. Out of 90 (68 Abdominal, 22 Knee) participants overall, 5 (5 Abdominal, 0 Knee) participants experienced at least one Surgical Site Infection (SSI) indicated by the given criteria. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Incidence of Surgical Site Complications (SSC) | Number of participants with incidence of Surgical Site Complications (SSC) within 30 days of surgery categorized as:
| Full Analysis Set (FAS) population included all enrolled participants with available data for the specified assessment. Out of 90 (68 Abdominal, 22 Knee) participants overall, 10 (9 Abdominal, 1 Knee) participants experienced at least one Surgical Site Complication (SSC) indicated by the given criteria. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Condition of Peri-Wound Skin Assessed Through Visual Inspection | Condition of peri-wound skin assessed through visual inspection by the investigator at baseline, 7, 14, and 30 days. Number of participants by Abdominal and Knee surgery type where skin was categorized with any condition that applied (i.e., multiple selections possible) from the following criteria:
| Full Analysis Set (FAS) population included enrolled participants with available data for the specified assessment at the time point indicated. Because multiple responses were possible, "Healthy" skin could be recorded along with any other conditions. Where this occurred, the investigator believed the other condition(s) selected did not affect the healthiness of the skin. | Posted | Count of Participants | Participants | Baseline, 7 days, 14 days, and 30 days |
|
|
|
| Secondary | Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection | Condition of skin under investigative single use Negative-Pressure Wound Therapy (NPWT) dressing assessed through visual inspection by the investigator at baseline, 7, 14, and 30 days. Number of participants by Abdominal and Knee surgery type where skin was categorized with any condition that applied (i.e., multiple selections possible) from the following criteria:
| Full Analysis Set (FAS) population included enrolled participants with available data for the specified assessment at the time point indicated. Because multiple responses were possible, "Healthy" skin could be recorded along with any other conditions. Where this occurred, the investigator believed the other condition(s) selected did not affect the healthiness of the skin. | Posted | Count of Participants | Participants | Baseline, 7 days, 14 days, and 30 days |
|
|
|
| Secondary | Wound and Skin Visual Analog Scale (VAS) Score Assessment | Wound and Skin VAS score assessment at 7, 14 and 30 days. Scores range from 0 to 100 with a low score associated to a wound with a major gapping, dehiscence, severe inflammation and/or infection (i.e., poor outcome); and a high correspond to a completely healed wound with no evidence for inflammation (i.e., excellent outcome). | Full Analysis Set (FAS) population included enrolled participants with available data for the specified assessment at the time point indicated. | Posted | Mean | Standard Deviation | score on a scale | 7 days, 14 days, and 30 days |
|
|
|
| Secondary | Range of Motion Assessment (ROM) for the Knee | Range of Motion (ROM) assessment for the knee at pre-operative visit, post-operative visit, 7, 14 and 30 days. | Data reported for knee extension in Knee Group interpreted as negative (extension deficit) or positive (actual extension). Therefore, ROM can be the sum or difference of reported knee flexion & extension. Because different Investigators applied different interpretations, there is low confidence in reliability of ROM data. Further investigation is required with additional clinical evaluations before the investigational NPWT device can be considered suitable for consideration in TKA subjects. | Posted | Mean | Standard Deviation | degrees | 30 days |
|
|
|
| Secondary | Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score | Level of pain during wear by investigational single use Negative-Pressure Wound Therapy (NPWT) Dressing at day 4 and day 7 assessed using a Visual Analog Scale (VAS) from 0 to 100 where a score of 0 indicated no pain and 100 indicated maximum pain. | Full Analysis Set (FAS) population included enrolled participants with available data for the specified assessment at the time point indicated. | Posted | Mean | Standard Deviation | score on a scale | 4 days and 7 days |
|
|
|
| Secondary | Level of Pain at Dressing Removal of the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score | Level of pain during dressing removal by Abdominal and Knee surgery type at treatment discontinuation (up to day 7) assessed using a Visual Analog Scale (VAS) from 0 to 100 where a score of 0 indicated no pain and 100 indicated maximum pain. | Full Analysis Set (FAS) population included enrolled participants with available data for the specified assessment at the time point indicated. | Posted | Mean | Standard Deviation | score on a scale | 7 days |
|
|
|
| 0 |
| 68 |
| 19 |
| 68 |
| 45 |
| 68 |
| EG001 | Knee | Knee surgery type with investigational single use NPWT dressing | 0 | 22 | 1 | 22 | 19 | 22 |
| Wound haemmorhage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Pumonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Wound secretion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Anastomic leak | Injury, poisoning and procedural complications | Systematic Assessment | 2 abdominal subjects discontinued from study due to Serious Adverse Event (SAE) |
|
| Haematoma infection | Infections and infestations | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Application site vesicles | General disorders | Systematic Assessment | Possibly related to study device and study procedure |
|
| Dysponea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Internal haemorrhage | Vascular disorders | Systematic Assessment | Subject discontinued from study due to SAE |
|
| Haemoglobin decreased | Investigations | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal rigidity | Gastrointestinal disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Application site vesicles | General disorders | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Blood glucose decreased | Investigations | Systematic Assessment |
|
| Blood lactic acid increased | Investigations | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | Systematic Assessment |
|
| Blood phosphorus decreased | Investigations | Systematic Assessment |
|
| Blood potassium | Investigations | Systematic Assessment |
|
| Blood potassium decreased | Investigations | Systematic Assessment |
|
| Blood pressure decreased | Investigations | Systematic Assessment |
|
| Blood sodium decreased | Investigations | Systematic Assessment |
|
| Bloody discharge | Vascular disorders | Systematic Assessment |
|
| Body temperature increased | Investigations | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | Systematic Assessment |
|
| Candida infection | Infections and infestations | Systematic Assessment |
|
| Chest discomfort | General disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
| Complication associated with device | General disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
|
| Discomfort | General disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Drain site complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Ear Pain | Ear and labyrinth disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Gastric dilatation | Gastrointestinal disorders | Systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Heart rate increased | Investigations | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hot flush | Vascular disorders | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypotension | Vascular disorders | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | Systematic Assessment |
|
| Incision site cellulitis | Infections and infestations | Systematic Assessment |
|
| Influenza like illness | General disorders | Systematic Assessment |
|
| Instillation site rash | General disorders | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Intra-abdominal fluid collection | Gastrointestinal disorders | Systematic Assessment |
|
| Iron deficiency | Metabolism and nutrition disorders | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lethargic | Nervous system disorders | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Nasogastric output abnormal | Investigations | Systematic Assessment |
|
| Nasogastric output high | Investigations | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Oedema peripheral | General disorders | Systematic Assessment |
|
| Orchitis | Infections and infestations | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Palpitations | Cardiac disorders | Systematic Assessment |
|
| Peripheral swelling | General disorders | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Postoperative hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Respiratory rate increased | Investigations | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Skin injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Somnolence | Nervous system disorders | Systematic Assessment |
|
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Urine analysis abnormal | Investigations | Systematic Assessment |
|
| Urine output decreased | Investigations | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| White blood cell count increased | Investigations | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound infection | Infections and infestations | Systematic Assessment |
|
Upon completion of the Clinical Investigation the PI may prepare the data derived from the Clinical Investigation for publication. Such data will be submitted to the Sponsor for review and comment prior to publication. In order to ensure that Sponsor will be able to make comment and suggestions where pertinent, the material for public dissemination will be submitted for review at least 60 days prior to submission for publication, public dissemination or review by a publication committee.
| Organ Space Infection |
|
| Other |
|
| Partial Dehiscence |
|
| Total Dehiscence |
|
| Seroma |
|
| Necrosis |
|
| Haematoma |
|
| Suture Abscess |
|
| Other |
|
| Baseline: Fragile |
|
|
| Baseline: Inflamed |
|
|
| Baseline: Erythema |
|
|
| Baseline: Bruising |
|
|
| Baseline: Eczematous |
|
|
| Baseline: Dry and Flaky |
|
|
| Baseline: Macerated |
|
|
| Baseline: Other |
|
|
| 7 Days: Healthy |
|
|
| 7 Days: Fragile |
|
|
| 7 Days: Inflamed |
|
|
| 7 Days: Erythema |
|
|
| 7 Days: Bruising |
|
|
| 7 Days: Eczematous |
|
|
| 7 Days: Dry and Flaky |
|
|
| 7 Days: Macerated |
|
|
| 7 Days: Other |
|
|
| 14 Days: Healthy |
|
|
| 14 Days: Fragile |
|
|
| 14 Days: Inflamed |
|
|
| 14 Days: Erythema |
|
|
| 14 Days: Bruising |
|
|
| 14 Days: Eczematous |
|
|
| 14 Days: Dry and Flaky |
|
|
| 14 Days: Macerated |
|
|
| 14 Days: Other |
|
|
| 30 Days: Healthy |
|
|
| 30 Days: Fragile |
|
|
| 30 Days: Inflamed |
|
|
| 30 Days: Erythema |
|
|
| 30 Days: Bruising |
|
|
| 30 Days: Eczematous |
|
|
| 30 Days: Dry and Flaky |
|
|
| 30 Days: Macerated |
|
|
| 30 Days: Other |
|
|
| Baseline: Fragile |
|
|
| Baseline: Inflamed |
|
|
| Baseline: Erythema |
|
|
| Baseline: Bruising |
|
|
| Baseline: Eczematous |
|
|
| Baseline: Dry and Flaky |
|
|
| Baseline: Macerated |
|
|
| Baseline: Other |
|
|
| 7 Days: Healthy |
|
|
| 7 Days: Fragile |
|
|
| 7 Days: Inflamed |
|
|
| 7 Days: Erythema |
|
|
| 7 Days: Bruising |
|
|
| 7 Days: Eczematous |
|
|
| 7 Days: Dry and Flaky |
|
|
| 7 Days: Macerated |
|
|
| 7 Days: Other |
|
|
| 14 Days: Healthy |
|
|
| 14 Days: Fragile |
|
|
| 14 Days: Inflamed |
|
|
| 14 Days: Erythema |
|
|
| 14 Days: Bruising |
|
|
| 14 Days: Eczematous |
|
|
| 14 Days: Dry and Flaky |
|
|
| 14 Days: Macerated |
|
|
| 14 Days: Other |
|
|
| 30 Days: Healthy |
|
|
| 30 Days: Fragile |
|
|
| 30 Days: Inflamed |
|
|
| 30 Days: Erythema |
|
|
| 30 Days: Bruising |
|
|
| 30 Days: Eczematous |
|
|
| 30 Days: Dry and Flaky |
|
|
| 30 Days: Macerated |
|
|
| 30 Days: Other |
|
|
| 14 Days |
|
|
| 30 Days |
|
|
|
| Pre-Operative - ROM |
|
|
| Post-Operative - Flexion |
|
|
| Post-Operative - Extension Angle |
|
|
| Post-Operative - ROM |
|
|
| Day 7 (Pre-Dressing Removal) - Flexion |
|
|
| Day 7 (Pre-Dressing Removal) - Extension Angle |
|
|
| Day 7 (Pre-Dressing Removal) - ROM |
|
|
| Day 7 (Post-Dressing Removal) - Flexion |
|
|
| Day 7 (Post-Dressing Removal) - Extension Angle |
|
|
| Day 7 (Post-Dressing Removal) - ROM |
|
|
| Day 14 - Flexion |
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| Day 14 - Extension Angle |
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| Day 14 - ROM |
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| Day 30 - Flexion |
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| Day 30 - Extension Angle |
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| Day 30 - ROM |
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| 7 Days |
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|