Wounds and InjuriesNCT07899814
Utilizing RENASYS◊ DYNAFLOW Instillation Therapy System for Wound Management in Adults With Acute and Chronic Wounds
A study testing RENASYS◊ DYNAFLOW Instillation Therapy in people with Wounds and Injuries, run by Smith & Nephew, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to investigate the functional performance of the RENASYS◊ DYNAFLOW Instillation Therapy System for wound management in adults with acute and chronic wounds. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wounds and Injuries
- What is being tested?
- RENASYS◊ DYNAFLOW Instillation Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2026to 10 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients must provide their own written informed consent
- Patient is at least 18 years old at time of consent
- Patient is or will be admitted as an in-patient, able to attend all required study visits and willing to undergo NPWTi treatment
- Patient must be able to follow instructions and in the opinion of the Investigator deemed capable of completing protocol requirements
- Patient has a target wound that meets all the following:
- Is acute (e.g. traumatic, partial thickness burns), sub-acute (e.g. surgical dehisced), or chronic (e.g. pressure or diabetic ulcer)
- Is an open wound with surface area 45-350 cm² and includes at least one planar dimension (length or width) ≥10 cm
- In the opinion of the Investigator, would be suitable for/could benefit from NPWTi treatment
Who cannot join
- Patient with target wound contraindicated to use of the product under investigation, ancillary products or their components per the RENASYS◊ DYNAFLOW Instillation Therapy System IFU
- Patient with target wound(s):
- Highly exuding
- Located in anatomical areas where maintaining a seal is problematic with tunnels or undermining that would prevent NPWT application
- Severe, unmanageable peri-wound compromise
- Uncontrolled clinically unstable localized infection
Show all 27Show fewer
- Contains non-sutured hemostatic agents (e.g., bone wax, absorbable gelatin sponge, spray wound sealant) that may be disrupted by NPWTi
- Requires drain device
- Containing surgical flaps or skin grafts
- Uncontrolled bleeding where hemostasis has not been achieved
- Patient with a medical or physical condition that, in the opinion of the Investigator, would preclude participation in the study, including but not limited to:
- Systemic infection or sepsis
- Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that will interfere with wound healing (e.g., biologics).
- Concomitant therapy local to the target wound that would interfere or conflict with NPWTi (e.g., compression, continuous enzymatic debriders)
- Require hyperbaric or high-pressure environment
- Patient with a known allergy or hypersensitivity to the product under investigation, ancillary products or their components
- Patient has participated in this trial previously and/or were withdrawn
- Patient is participating in the treatment period of another interventional clinical trial within thirty (30) days of informed consent, or during the study
- Patient has skin features (e.g., tattoos, skin color, pre-existing scarring) which in the opinion of the Investigator could impact the study assessment or risk identification of the patient in study documentation/wound photography
- Patient meets the definition of vulnerable persons per ISO14155 section 3.56[1]
- Patient with a known history of poor compliance with medical treatment that in the opinion of the Investigator would preclude full participation in the trial
- Patient is of childbearing potential (WOCBP) [2] who at the time of screening/treatment meets any of the following:
- Pregnant as determined by a positive pregnancy test (serum or urine)
- Breastfeeding or lactating
- Planning to become pregnant during study participation
- [1] ISO 14155:2026 Section 3.56 states: Vulnerable subject - individuals who are unable to fully understand all aspects of the clinical investigation that are relevant to the decision to participate, or who can be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response determined by physical, social, economic and environmental factors or processes.
- [2] Women of Childbearing Potential (WOCBP) are defined as individuals with a uterus who have reached menarche and are not post-menopausal (defined as ≥12 consecutive months of amenorrhea without an alternative medical cause) and who have not undergone permanent surgical sterilisation (e.g., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Michael Howarth contact
United States1 site
Regions Hospital
Saint Paul, Minnesota, 55101
Iris Guo, +1 651-254-4846, Iris.M.Guo@healthpartners.com
James Kenny, MD, FACS
About this study
Official title: A Prospective, Multicenter, Interventional, Single-arm, Post-Market Study Using a Negative Pressure Wound Therapy Instillation System
The purpose of this study is to investigate the functional performance of the RENASYS◊ DYNAFLOW Instillation Therapy System for wound management in adults with acute and chronic wounds. The main question is for clinicians to assess whether this device is completely unsuitable, neutral, or completely suitable for wound management using negative pressure wound therapy with instillation. Participants will have up to 3 dressings applied over their wound with saline administered via negative pressure for up to 9 days and participate in ongoing checkups by the study team.
Read the detailed description
Negative Pressure Wound Therapy (NPWT) is widely used for the management of acute and chronic wounds and has demonstrated clinical utility through controlled removal of wound exudate, reduction of edema, and promotion of granulation tissue formation. An extension of this approach, Negative Pressure Wound Therapy with instillation (NPWTi), combines NPWT with the controlled delivery of saline to the wound bed. NPWTi is increasingly used for complex wounds where enhanced wound bed cleansing, management of non-viable tissue, and control of local bioburden are desired as part of wound management.
The RENASYS◊ DYNAFLOW Instillation Therapy System consists of the RENASYS◊ DYNAFLOW Instillation Therapy Kit, RENASYS◊-F Foam Dressing Kit with Soft Port, RENASYS◊ TOUCH NPWT Pump, and RENASYS◊ TOUCH 800 mL Canister and is designed to deliver continuous or intermittent saline instillation to the wound bed while maintaining negative pressure therapy for the management of wound fluids and exudate. The system may also utilize dwell time as a separate therapy mode, in which saline is intermittently delivered to the wound, allowed to stay on the wound for a specified period, and then removed during negative pressure therapy.
This post-market clinical investigation has been designed to generate functional performance and operational data under conditions representative of routine inpatient clinical use for acute and chronic wounds. The study will also collect information related to device deficiencies and safety events to further characterize the post-market performance profile of the system. Results from the study may help inform future clinical research and support ongoing assessment of the device's performance and usability in clinical practice.
Participants will have the dressings and negative pressure system applied over the indicated wound and participate in either continuous, intermittent, or dwell therapy modes per clinical judgment. Study participation will last up to 9 days and may include up to 3 separate dressing changes. Additional assessments include wound photography, review of the health and status of the skin around the wound, bacterial growth within the wound, and satisfaction surveys for clinicians and the participants.
- Conditions
- Wounds and Injuries
- Being tested
- RENASYS◊ DYNAFLOW Instillation Therapy
- Keywords
- Negative pressure wound therapy, Wound instillation therapy
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RENASYS◊ DYNAFLOW Instillation TherapyDevice
Negative Pressure Wound Therapy with saline instillation and/or dwell
| Study group | Role | What they receive |
|---|---|---|
| RENASYS◊ DYNAFLOW Instillation Therapy System | Experimental | RENASYS◊ DYNAFLOW Instillation Therapy System as treatment for acute and chronic wounds Receives: Device: RENASYS◊ DYNAFLOW Instillation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Performance of the RENASYS◊ DYNAFLOW Instillation Therapy System in an acute care setting
Functional performance is defined by a clinician-assessed questionnaire with a 1-10 numeric rating scale (completely unsuitable [1]; neutral [5]; completely suitable [10]) of the RENASYS◊ DYNAFLOW Instillation Therapy System that is collected at end of treatment after final dressing removal. A higher rating score indicates a better performance outcome for the device.
Measured: Day 9
Secondary outcomes (1)
Application time of the RENASYS◊ DYNAFLOW Instillation Therapy System in an acute care setting
Instillation application time is measured in minutes and seconds from completion of RENASYS◊ foam and transparent film application through to completion of instillation system priming (when saline is visibly present within the foam dressing). A shorter application time indicates better device performance.
Measured: During dressing application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion5 Mar 2027 (estimated)
- Study completion10 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gayle Blevins, Study chair, Smith & Nephew, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899814
- Sponsor's protocol ID
- SNIS-W-1328
- Status last verified
- Sep 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Interventional, Single-arm, Post-Market Study Using a Negative Pressure Wound Therapy Instillation System
- ClinicalTrials.gov ID
- NCT07899814
- Acronym / sponsor ID
- SNIS-W-1328
- Conditions
- Wounds and Injuries
- Keywords
- Negative pressure wound therapy, Wound instillation therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 5 Mar 2027 (estimated)
- Study completion
- 10 May 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the functional performance of the RENASYS◊ DYNAFLOW Instillation Therapy System for wound management in adults with acute and chronic wounds. The main question is for clinicians to assess whether this device is completely unsuitable, neutral, or completely suitable for wound management using negative pressure wound therapy with instillation. Participants will have up to 3 dressings applied over their wound with saline administered via negative pressure for up to 9 days and participate in ongoing checkups by the study team.
Detailed description
Negative Pressure Wound Therapy (NPWT) is widely used for the management of acute and chronic wounds and has demonstrated clinical utility through controlled removal of wound exudate, reduction of edema, and promotion of granulation tissue formation. An extension of this approach, Negative Pressure Wound Therapy with instillation (NPWTi), combines NPWT with the controlled delivery of saline to the wound bed. NPWTi is increasingly used for complex wounds where enhanced wound bed cleansing, management of non-viable tissue, and control of local bioburden are desired as part of wound management.
The RENASYS◊ DYNAFLOW Instillation Therapy System consists of the RENASYS◊ DYNAFLOW Instillation Therapy Kit, RENASYS◊-F Foam Dressing Kit with Soft Port, RENASYS◊ TOUCH NPWT Pump, and RENASYS◊ TOUCH 800 mL Canister and is designed to deliver continuous or intermittent saline instillation to the wound bed while maintaining negative pressure therapy for the management of wound fluids and exudate. The system may also utilize dwell time as a separate therapy mode, in which saline is intermittently delivered to the wound, allowed to stay on the wound for a specified period, and then removed during negative pressure therapy.
This post-market clinical investigation has been designed to generate functional performance and operational data under conditions representative of routine inpatient clinical use for acute and chronic wounds. The study will also collect information related to device deficiencies and safety events to further characterize the post-market performance profile of the system. Results from the study may help inform future clinical research and support ongoing assessment of the device's performance and usability in clinical practice.
Participants will have the dressings and negative pressure system applied over the indicated wound and participate in either continuous, intermittent, or dwell therapy modes per clinical judgment. Study participation will last up to 9 days and may include up to 3 separate dressing changes. Additional assessments include wound photography, review of the health and status of the skin around the wound, bacterial growth within the wound, and satisfaction surveys for clinicians and the participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RENASYS◊ DYNAFLOW Instillation Therapy System | Experimental | Device: RENASYS◊ DYNAFLOW Instillation TherapyRENASYS◊ DYNAFLOW Instillation Therapy System as treatment for acute and chronic wounds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must provide their own written informed consent
- Patient is at least 18 years old at time of consent
- Patient is or will be admitted as an in-patient, able to attend all required study visits and willing to undergo NPWTi treatment
- Patient must be able to follow instructions and in the opinion of the Investigator deemed capable of completing protocol requirements
- Patient has a target wound that meets all the following:
Key exclusion criteria (27 listed)
- Patient with target wound contraindicated to use of the product under investigation, ancillary products or their components per the RENASYS◊ DYNAFLOW Instillation Therapy System IFU
- Patient with target wound(s):
- Patient with a medical or physical condition that, in the opinion of the Investigator, would preclude participation in the study, including but not limited to:
- Patient with a known allergy or hypersensitivity to the product under investigation, ancillary products or their components
- Patient has participated in this trial previously and/or were withdrawn
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 |
|---|---|---|
| RENASYS◊ DYNAFLOW Instillation TherapyNegative Pressure Wound Therapy with saline instillation and/or dwell | Device | RENASYS◊ DYNAFLOW Instillation Therapy System |
Primary outcome
Functional Performance of the RENASYS◊ DYNAFLOW Instillation Therapy System in an acute care setting
Time frame: Day 9
Functional performance is defined by a clinician-assessed questionnaire with a 1-10 numeric rating scale (completely unsuitable [1]; neutral [5]; completely suitable [10]) of the RENASYS◊ DYNAFLOW Instillation Therapy System that is collected at end of treatment after final dressing removal. A higher rating score indicates a better performance outcome for the device.
1 secondary outcome
Application time of the RENASYS◊ DYNAFLOW Instillation Therapy System in an acute care setting
Time frame: During dressing application
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Howarth contact
Gayle Blevins study chair
Smith & Nephew, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RENASYS◊ DYNAFLOW Instillation Therapy in people with Wounds and Injuries, run by Smith & Nephew, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay Dobson (+1 206-495-7058, Jay.Dobson@smith-nephew.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Performance of the RENASYS◊ DYNAFLOW Instillation Therapy System in an acute care setting (time frame: Day 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.