Trial Outcomes & Findings for Performance, Safety and Efficacy of NPWT Device (NCT NCT04102865)

Last Updated: 2024-12-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

90 participants

Primary outcome timeframe

30 days post-op

Results posted on

2024-12-11

Participant Flow

Enrollment began 12 July 2019 to 01 February 2022 across 8 investigative sites.

Participant milestones

Participant milestones
Measure	Abdominal Abdominal surgery type with investigational single use NPWT dressing	Knee Knee surgery type with investigational single use NPWT dressing
Overall Study STARTED	68	22
Overall Study COMPLETED	61	22
Overall Study NOT COMPLETED	7	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Abdominal Abdominal surgery type with investigational single use NPWT dressing	Knee Knee surgery type with investigational single use NPWT dressing
Overall Study Adverse Event	4	0
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Performance, Safety and Efficacy of NPWT Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abdominal n=68 Participants Abdominal surgery type with investigational single use NPWT dressing	Knee n=22 Participants Knee surgery type with investigational single use NPWT dressing	Total n=90 Participants Total of all reporting groups
Age, Continuous	66.9 years STANDARD_DEVIATION 11.9 • n=5 Participants	70.4 years STANDARD_DEVIATION 7.6 • n=7 Participants	67.8 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	14 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	8 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	67 Participants n=5 Participants	22 Participants n=7 Participants	89 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White British	63 Participants n=5 Participants	22 Participants n=7 Participants	85 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White Irish	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Any Other White Background	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White and Asian Mixed	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Not Stated	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United Kingdom	68 participants n=5 Participants	22 participants n=7 Participants	90 participants n=5 Participants
Body Mass Index (BMI)	28.0 kg/m^2 STANDARD_DEVIATION 5.2 • n=5 Participants	31.5 kg/m^2 STANDARD_DEVIATION 3.4 • n=7 Participants	28.9 kg/m^2 STANDARD_DEVIATION 5.0 • n=5 Participants

PRIMARY outcome

Timeframe: 30 days post-op

Population: Full Analysis Set (FAS) population included enrolled participants with available data for the surgery type specified.

Outcome measures

Outcome measures
Measure	Abdominal n=58 Participants Abdominal surgery type with investigational single use NPWT dressing	Knee n=18 Participants Knee surgery type with investigational single use NPWT dressing
Negative Pressure Maintenance at Nominal 80 mmHg	-71.5 millimeters of mercury (mmHg) Standard Deviation 25.1	-56.0 millimeters of mercury (mmHg) Standard Deviation 28.2

PRIMARY outcome

Timeframe: 7 days

Population: Full Analysis Set (FAS) population included enrolled participants with available data for the surgery type specified.

Dressing wear time in days as assessed of any unplanned dressing change by Abdominal and Knee surgery type.

Outcome measures

Outcome measures
Measure	Abdominal n=68 Participants Abdominal surgery type with investigational single use NPWT dressing	Knee n=22 Participants Knee surgery type with investigational single use NPWT dressing
Dressing Wear Time	5.7 days Standard Deviation 2.4	5.3 days Standard Deviation 2.1

PRIMARY outcome

Timeframe: 7 days

Population: Full Analysis Set (FAS) population included enrolled participants with available data for the surgery type specified.

Number of participants with occurrence of exudate leaks. Leakage classified as 'Any Leak' (Yes/No) by Abdominal and Knee surgery type.

Outcome measures

Outcome measures
Measure	Abdominal n=68 Participants Abdominal surgery type with investigational single use NPWT dressing	Knee n=22 Participants Knee surgery type with investigational single use NPWT dressing
Exudate Management (Occurrence of Exudate Leaks) Any Leak: Yes	5 Participants	12 Participants
Exudate Management (Occurrence of Exudate Leaks) Any Leak: No	63 Participants	10 Participants

SECONDARY outcome

Timeframe: 30 days

Population: 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.

Number of participants with incidence of Surgical Site Infection (SSI) within 30 days of surgery classified using Centers for Decease Control (CDC) criteria of: * Superficial Infection * Deep Infection * Organ Space Infection * Other

Outcome measures

Outcome measures
Measure	Abdominal n=68 Participants Abdominal surgery type with investigational single use NPWT dressing	Knee n=22 Participants Knee surgery type with investigational single use NPWT dressing
Incidence of Surgical Site Infection (SSI) Superficial Infection	3 Participants	0 Participants
Incidence of Surgical Site Infection (SSI) Deep Infection	2 Participants	0 Participants
Incidence of Surgical Site Infection (SSI) Organ Space Infection	1 Participants	0 Participants
Incidence of Surgical Site Infection (SSI) Other	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days

Population: 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.

Number of participants with incidence of Surgical Site Complications (SSC) within 30 days of surgery categorized as: * Deep Dehiscence * Superficial Dehiscence * Partial Dehiscence * Total Dehiscence * Seroma * Necrosis * Hematoma * Suture Abscess * Other

Outcome measures

Outcome measures
Measure	Abdominal n=68 Participants Abdominal surgery type with investigational single use NPWT dressing	Knee n=22 Participants Knee surgery type with investigational single use NPWT dressing
Incidence of Surgical Site Complications (SSC) Total Dehiscence	1 Participants	0 Participants
Incidence of Surgical Site Complications (SSC) Seroma	0 Participants	0 Participants
Incidence of Surgical Site Complications (SSC) Suture Abscess	0 Participants	0 Participants
Incidence of Surgical Site Complications (SSC) Other	2 Participants	1 Participants
Incidence of Surgical Site Complications (SSC) Deep Dehiscence	2 Participants	0 Participants
Incidence of Surgical Site Complications (SSC) Superficial Dehiscence	6 Participants	0 Participants
Incidence of Surgical Site Complications (SSC) Partial Dehiscence	5 Participants	0 Participants
Incidence of Surgical Site Complications (SSC) Necrosis	0 Participants	0 Participants
Incidence of Surgical Site Complications (SSC) Haematoma	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, 7 days, 14 days, and 30 days

Population: 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.

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: * Healthy * Fragile * Inflamed * Erythema * Bruising * Eczematous * Dry and Flaky * Macerated * Other

Outcome measures

Outcome measures
Measure	Abdominal n=68 Participants Abdominal surgery type with investigational single use NPWT dressing	Knee n=22 Participants Knee surgery type with investigational single use NPWT dressing
Condition of Peri-Wound Skin Assessed Through Visual Inspection Baseline: Fragile	4 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 7 Days: Other	4 Participants	3 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 14 Days: Healthy	59 Participants	21 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 14 Days: Fragile	2 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 14 Days: Eczematous	2 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 14 Days: Dry and Flaky	5 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 30 Days: Healthy	59 Participants	22 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 30 Days: Fragile	4 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 30 Days: Erythema	3 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 30 Days: Bruising	0 Participants	2 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 30 Days: Other	4 Participants	2 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 14 Days: Macerated	1 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 14 Days: Other	6 Participants	3 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection Baseline: Healthy	68 Participants	22 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection Baseline: Inflamed	2 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection Baseline: Erythema	2 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection Baseline: Bruising	0 Participants	1 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection Baseline: Eczematous	0 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection Baseline: Dry and Flaky	0 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection Baseline: Macerated	0 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection Baseline: Other	1 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 7 Days: Healthy	59 Participants	19 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 7 Days: Fragile	1 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 7 Days: Inflamed	4 Participants	2 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 7 Days: Erythema	2 Participants	1 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 7 Days: Bruising	35 Participants	12 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 7 Days: Eczematous	1 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 7 Days: Dry and Flaky	3 Participants	1 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 7 Days: Macerated	1 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 14 Days: Inflamed	7 Participants	3 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 14 Days: Erythema	9 Participants	2 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 14 Days: Bruising	17 Participants	5 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 30 Days: Inflamed	3 Participants	1 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 30 Days: Eczematous	1 Participants	0 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 30 Days: Dry and Flaky	9 Participants	4 Participants
Condition of Peri-Wound Skin Assessed Through Visual Inspection 30 Days: Macerated	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, 7 days, 14 days, and 30 days

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: * Healthy * Fragile * Inflamed * Erythema * Bruising * Eczematous * Dry and Flaky * Macerated * Other

Outcome measures

Outcome measures
Measure	Abdominal n=68 Participants Abdominal surgery type with investigational single use NPWT dressing	Knee n=22 Participants Knee surgery type with investigational single use NPWT dressing
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection Baseline: Healthy	68 Participants	22 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection Baseline: Fragile	1 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection Baseline: Eczematous	0 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 7 Days: Healthy	62 Participants	19 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 14 Days: Fragile	2 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 14 Days: Erythema	1 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 14 Days: Dry and Flaky	1 Participants	1 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 14 Days: Other	2 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 30 Days: Healthy	60 Participants	21 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 30 Days: Inflamed	1 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 30 Days: Eczematous	1 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 30 Days: Other	1 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection Baseline: Inflamed	0 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection Baseline: Erythema	0 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection Baseline: Bruising	13 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection Baseline: Dry and Flaky	0 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection Baseline: Macerated	0 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection Baseline: Other	0 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 7 Days: Fragile	0 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 7 Days: Inflamed	1 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 7 Days: Erythema	1 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 7 Days: Bruising	10 Participants	3 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 7 Days: Eczematous	0 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 7 Days: Dry and Flaky	1 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 7 Days: Macerated	0 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 7 Days: Other	3 Participants	3 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 14 Days: Healthy	64 Participants	21 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 14 Days: Inflamed	1 Participants	1 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 14 Days: Bruising	6 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 14 Days: Eczematous	1 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 14 Days: Macerated	0 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 30 Days: Fragile	1 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 30 Days: Erythema	3 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 30 Days: Bruising	0 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 30 Days: Dry and Flaky	3 Participants	0 Participants
Condition of Skin Under the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed Through Visual Inspection 30 Days: Macerated	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 7 days, 14 days, and 30 days

Population: Full Analysis Set (FAS) population included enrolled participants with available data for the specified assessment at the time point indicated.

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).

Outcome measures

Outcome measures
Measure	Abdominal n=66 Participants Abdominal surgery type with investigational single use NPWT dressing	Knee n=22 Participants Knee surgery type with investigational single use NPWT dressing
Wound and Skin Visual Analog Scale (VAS) Score Assessment 7 Days	79.0 score on a scale Standard Deviation 26.7	89.9 score on a scale Standard Deviation 7.4
Wound and Skin Visual Analog Scale (VAS) Score Assessment 14 Days	81.4 score on a scale Standard Deviation 26.1	89.4 score on a scale Standard Deviation 10.4
Wound and Skin Visual Analog Scale (VAS) Score Assessment 30 Days	85.0 score on a scale Standard Deviation 27.6	95.0 score on a scale Standard Deviation 5.6

SECONDARY outcome

Timeframe: 30 days

Population: 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.

Range of Motion (ROM) assessment for the knee at pre-operative visit, post-operative visit, 7, 14 and 30 days.

Outcome measures

Outcome measures
Measure	Abdominal n=22 Participants Abdominal surgery type with investigational single use NPWT dressing	Knee Knee surgery type with investigational single use NPWT dressing
Range of Motion Assessment (ROM) for the Knee Pre-Operative - Flexion	102.5 degrees Standard Deviation 17.2	—
Range of Motion Assessment (ROM) for the Knee Pre-Operative - Extension Angle	9.4 degrees Standard Deviation 7.7	—
Range of Motion Assessment (ROM) for the Knee Pre-Operative - ROM	93.1 degrees Standard Deviation 20.7	—
Range of Motion Assessment (ROM) for the Knee Post-Operative - Flexion	61.6 degrees Standard Deviation 20.3	—
Range of Motion Assessment (ROM) for the Knee Post-Operative - Extension Angle	6.6 degrees Standard Deviation 5.9	—
Range of Motion Assessment (ROM) for the Knee Post-Operative - ROM	54.9 degrees Standard Deviation 21.6	—
Range of Motion Assessment (ROM) for the Knee Day 7 (Pre-Dressing Removal) - Flexion	75.5 degrees Standard Deviation 16.1	—
Range of Motion Assessment (ROM) for the Knee Day 7 (Pre-Dressing Removal) - Extension Angle	14.2 degrees Standard Deviation 9.5	—
Range of Motion Assessment (ROM) for the Knee Day 7 (Pre-Dressing Removal) - ROM	61.6 degrees Standard Deviation 16.6	—
Range of Motion Assessment (ROM) for the Knee Day 7 (Post-Dressing Removal) - Flexion	75.6 degrees Standard Deviation 19.7	—
Range of Motion Assessment (ROM) for the Knee Day 7 (Post-Dressing Removal) - Extension Angle	11.2 degrees Standard Deviation 6.9	—
Range of Motion Assessment (ROM) for the Knee Day 7 (Post-Dressing Removal) - ROM	64.4 degrees Standard Deviation 18.2	—
Range of Motion Assessment (ROM) for the Knee Day 14 - Flexion	86.3 degrees Standard Deviation 17.2	—
Range of Motion Assessment (ROM) for the Knee Day 14 - Extension Angle	10.2 degrees Standard Deviation 6.3	—
Range of Motion Assessment (ROM) for the Knee Day 14 - ROM	76.0 degrees Standard Deviation 18.1	—
Range of Motion Assessment (ROM) for the Knee Day 30 - Flexion	100.4 degrees Standard Deviation 15.8	—
Range of Motion Assessment (ROM) for the Knee Day 30 - Extension Angle	8.7 degrees Standard Deviation 5.6	—
Range of Motion Assessment (ROM) for the Knee Day 30 - ROM	91.6 degrees Standard Deviation 15.9	—

SECONDARY outcome

Timeframe: 4 days and 7 days

Population: Full Analysis Set (FAS) population included enrolled participants with available data for the specified assessment at the time point indicated.

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.

Outcome measures

Outcome measures
Measure	Abdominal n=60 Participants Abdominal surgery type with investigational single use NPWT dressing	Knee n=17 Participants Knee surgery type with investigational single use NPWT dressing
Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score 4 Days	20.2 score on a scale Standard Deviation 24.7	41.8 score on a scale Standard Deviation 28.8
Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score 7 Days	14.2 score on a scale Standard Deviation 20.5	35.4 score on a scale Standard Deviation 26.0

SECONDARY outcome

Timeframe: 7 days

Population: Full Analysis Set (FAS) population included enrolled participants with available data for the specified assessment at the time point indicated.

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.

Outcome measures

Outcome measures
Measure	Abdominal n=67 Participants Abdominal surgery type with investigational single use NPWT dressing	Knee n=22 Participants Knee surgery type with investigational single use NPWT dressing
Level of Pain at Dressing Removal of the Investigative Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score	12.6 score on a scale Standard Deviation 18.3	31.6 score on a scale Standard Deviation 30.7

Adverse Events

Abdominal

Serious events: 19 serious events

Other events: 45 other events

Deaths: 0 deaths

Knee

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Manager Clinical Compliance

Smith+Nephew, Inc

Phone: +44 7811 407089

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER

Measure	Abdominal n=68 participants at risk Abdominal surgery type with investigational single use NPWT dressing	Knee n=22 participants at risk Knee surgery type with investigational single use NPWT dressing
General disorders Peripheral swelling	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Injury, poisoning and procedural complications Wound haemmorhage	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Respiratory, thoracic and mediastinal disorders Pumonary Embolism	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Nervous system disorders Dizziness	0.00% 0/68 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	4.5% 1/22 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Vascular disorders Deep vein thrombosis	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	4.5% 1/22 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Nervous system disorders Cerebrovascular accident	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Infections and infestations Postoperative wound infection	2.9% 2/68 • Number of events 2 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Gastrointestinal disorders Vomiting	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Injury, poisoning and procedural complications Wound secretion	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Gastrointestinal disorders Intestinal obstruction	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Injury, poisoning and procedural complications Anastomic leak	5.9% 4/68 • Number of events 4 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Infections and infestations Haematoma infection	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Metabolism and nutrition disorders Hyponatraemia	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
General disorders Application site vesicles	0.00% 0/68 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	4.5% 1/22 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Respiratory, thoracic and mediastinal disorders Dysponea	0.00% 0/68 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	4.5% 1/22 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Infections and infestations Cellulitis	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Vascular disorders Internal haemorrhage	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Investigations Haemoglobin decreased	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Gastrointestinal disorders Small intestinal obstruction	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.
Infections and infestations Respiratory tract infection viral	1.5% 1/68 • Number of events 1 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.	0.00% 0/22 • Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.