Wound Healing and PreventionNCT04102865

Performance, Safety and Efficacy of NPWT Device

A study testing Negative-Pressure Wound Therapy (NPWT) in people with Wound Healing and Prevention, run by Smith & Nephew, Inc. at 8 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Smith \& Nephew are assessing a new investigational single use NPWT system. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Wound Healing and Prevention
What is being tested?: Negative-Pressure Wound Therapy (NPWT)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 8 sitesUnited Kingdom
Study dates: 12 Jul 2019to 27 Jul 2022
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

The subject must provide written informed consent.
Subjects eighteen (18) years of age or older.
Willing and able to make all required study visits.
Able to follow instructions.
Subject is suitable to participate in the study in the opinion of the Investigator
In Orthopaedic surgery: subject is scheduled for an elective primary knee replacement arthroplasty and American Society of Anesthesiologists (ASA) score of 2-3 (Phase 1 only)
In Abdominal surgery: subject is scheduled for an elective open or laparoscopic gastrointestinal and/or gynaecological surgery with incision ≥5 cm and has an ASA score of 2-3.
Immediately after the surgery, subject will have one suitable closed abdominal or knee surgery incision (if there is more than one incision, then the clinician should choose the one which, in their opinion, is most suited for Negative Pressure Wound Therapy) that fits under the absorbent dressing area of the appropriate Negative Pressure dressing sizes .

Who cannot join

Contraindications (per the Investigator Brochure) or hypersensitivity to the use of the investigational product or their components (e.g. silicone adhesives and polyurethane films [direct contact with incision], acrylic adhesives [direct contact with skin], polyethylene fabrics and super-absorbent powders [polyacrylates]) within the dressing).
Subjects with extremely fragile skin who require the use of SECURA™ non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes
Participation in the treatment period of another similar clinical trial (wound care related) within thirty (30) days of operative visit or during the study.
Subjects with skin features (e.g. tattoos, skin colour, pre-existing scarring) which in the opinion of the Investigator, will interfere with the study assessments.
Subjects attending for an operation at the same surgery site (anatomical location) within the last 3 months
Subjects undergoing a procedure as part of palliative care (to be confirmed during surgery).

Show all 13Show fewer

Subjects where the area of the device would be placed on a load-bearing anatomical location (i.e. areas vulnerable to pressure damage).
Subjects with incisions that are actively bleeding unless haemostasis has been achieved (to be confirmed during surgery).
Subjects with infected skin lesions or incisions at the time of surgery (any area of the body).
Subjects who have participated previously in this clinical trial
Subjects with a history of poor compliance with medical treatment.
Subjects with a BMI ≥ 40.
Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United Kingdom8 sites

Queen Elizabeth Hospital
Birmingham
Western General Hospital
Edinburgh, EH4 2XU
Queen Elizabeth the Queen Mother Hospital
Margate
North Tyneside General Hospital
North Shields
RJAH Orthopaedic Hospital
Oswestry
Peterborough City Hospital
Peterborough
Torbay Hospital
Torquay
Worthing Hospital
Worthing, West Sussex, BN11 2DH

Other trials in United Kingdom

About this study

Official title: NPWT Pre-registration Study: A Prospective, Multicentre Trial to Assess Performance, Safety and Efficacy of a Single-use NPWT Device

Smith \& Nephew are assessing a new investigational single use NPWT system.

Read the detailed description

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.

Conditions: Wound Healing and Prevention
Being tested: Negative-Pressure Wound Therapy (NPWT)
Keywords: surgical complication, Negative-Pressure Wound Therapy (NPWT), negative pressure, knee arthroplasty, abdominal incision

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Negative-Pressure Wound Therapy (NPWT)Device
Also called NPWT system
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.

Study groups in NCT04102865
Study group	Role	What they receive
Abdominal	Other	Abdominal surgery type with investigational single use NPWT dressing Receives: Device: Negative-Pressure Wound Therapy (NPWT)
Knee	Other	Knee surgery type with investigational single use NPWT dressing Receives: Device: Negative-Pressure Wound Therapy (NPWT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 7 days

Secondary outcomes (8)

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:
- Superficial Infection
- Deep Infection
- Organ Space Infection
- Other
Measured: 30 days
Incidence of Surgical Site Complications (SSC)
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
Measured: 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:
- Healthy
- Fragile
- Inflamed
- Erythema
- Bruising
- Eczematous
- Dry and Flaky
- Macerated
- Other
Measured: 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:
- Healthy
- Fragile
- Inflamed
- Erythema
- Bruising
- Eczematous
- Dry and Flaky
- Macerated
- Other
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jul 201927 Jul 2022

First posted25 Sep 2019
Study start12 Jul 2019
Primary completion6 Jul 2022
Study completion27 Jul 2022

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 Healing and PreventionStudies of the same condition, open and under way.
More trials run by Smith & Nephew, Inc.The 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: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04102865
Sponsor's protocol ID: CT1705POB
Status last verified: Dec 2022
First submitted: 26 Apr 2018
Last updated: 11 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NPWT Pre-registration Study: A Prospective, Multicentre Trial to Assess Performance, Safety and Efficacy of a Single-use NPWT Device
ClinicalTrials.gov ID: NCT04102865
Acronym / sponsor ID: CT1705POB
Conditions: Wound Healing and Prevention
Keywords: surgical complication, Negative-Pressure Wound Therapy (NPWT), negative pressure, knee arthroplasty, abdominal incision
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Smith & Nephew, Inc.Industry (pharma, biotech, devices)
Study start: 12 Jul 2019 (actual)
Primary completion: 6 Jul 2022 (actual)
Study completion: 27 Jul 2022 (actual)
First posted: 25 Sep 2019 (actual)
Results: Posted 21 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Smith \& Nephew are assessing a new investigational single use NPWT system.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Abdominal	Other	Device: Negative-Pressure Wound Therapy (NPWT)Abdominal surgery type with investigational single use NPWT dressing
Knee	Other	Device: Negative-Pressure Wound Therapy (NPWT)Knee surgery type with investigational single use NPWT dressing

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

The subject must provide written informed consent.
Subjects eighteen (18) years of age or older.
Willing and able to make all required study visits.
Able to follow instructions.
Subject is suitable to participate in the study in the opinion of the Investigator

Key exclusion criteria (13 listed)

Contraindications (per the Investigator Brochure) or hypersensitivity to the use of the investigational product or their components (e.g. silicone adhesives and polyurethane films [direct contact with incision], acrylic adhesives [direct contact with skin], polyethylene fabrics and super-absorbent powders [polyacrylates]) within the dressing).
Subjects with extremely fragile skin who require the use of SECURA™ non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes
Participation in the treatment period of another similar clinical trial (wound care related) within thirty (30) days of operative visit or during the study.
Subjects with skin features (e.g. tattoos, skin colour, pre-existing scarring) which in the opinion of the Investigator, will interfere with the study assessments.
Subjects attending for an operation at the same surgery site (anatomical location) within the last 3 months

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Negative-Pressure Wound Therapy (NPWT)Also: NPWT systemInvestigational 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.	Device	Abdominal, Knee

Primary outcome

Negative Pressure Maintenance at Nominal 80 mmHg
Time frame: 30 days post-op
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.
Dressing Wear Time
Time frame: 7 days
Dressing wear time in days as assessed of any unplanned dressing change by Abdominal and Knee surgery type.
Exudate Management (Occurrence of Exudate Leaks)
Time frame: 7 days
Number of participants with occurrence of exudate leaks. Leakage classified as 'Any Leak' (Yes/No) by Abdominal and Knee surgery type.

8 secondary outcomes

Incidence of Surgical Site Infection (SSI)
Time frame: 30 days
Incidence of Surgical Site Complications (SSC)
Time frame: 30 days
Condition of Peri-Wound Skin Assessed Through Visual Inspection
Time frame: 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
Time frame: Baseline, 7 days, 14 days, and 30 days
Wound and Skin Visual Analog Scale (VAS) Score Assessment
Time frame: 7 days, 14 days, and 30 days
Range of Motion Assessment (ROM) for the Knee
Time frame: 30 days
Level of Pain During Wear of the Investigational Single Use Negative-Pressure Wound Therapy (NPWT) Dressing Assessed by VAS Score
Time frame: 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
Time frame: 7 days

Results and safety

Results posted to the registry on 21 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Abdominal	68	61
Knee	22	22

Primary outcome: Negative Pressure Maintenance at Nominal 80 mmHg

Time frame: 30 days post-op. Mean (Standard Deviation). Unit: millimeters of mercury (mmHg)

Measure	Abdominal n = 58	Knee n = 18
Value	-71.5 (25.1)	-56.0 (28.2)

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

Primary outcome: Dressing Wear Time

Time frame: 7 days. Mean (Standard Deviation). Unit: days

Measure	Abdominal n = 68	Knee n = 22
Value	5.7 (2.4)	5.3 (2.1)

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

Primary outcome: Exudate Management (Occurrence of Exudate Leaks)

Time frame: 7 days. Count of participants. Unit: Participants

Measure	Abdominal n = 68	Knee n = 22
Any Leak: Yes	5	12
Any Leak: No	63	10

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

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected upon investigational single use NPWT dressing application to 30 days post-surgery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Abdominal	19 of 68 (27.9%)	45 of 68 (66.2%)	0 of 68
Knee	1 of 22 (4.5%)	19 of 22 (86.4%)	0 of 22

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Steven Jeffery principal investigator

Queen Elizabeth Hospital, Birmingham, UK

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Negative-Pressure Wound Therapy (NPWT) in people with Wound Healing and Prevention, run by Smith & Nephew, Inc. at 8 sites in United Kingdom.

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 8 inclusion and 13 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 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United Kingdom. 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 21 Nov 2024). 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?

Negative Pressure Maintenance at Nominal 80 mmHg (time frame: 30 days post-op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04102865.

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 11 Dec 2024.