Surgical WoundNCT04053946
Clinical Assessment of Next Science Wound Gels in Healing Below the Knee Amputation Surgical Wound Compared to SOC
A study testing Next Science Wounds Gels in people with Surgical Wound and Surgical Site Infection, run by Next Science TM.
Trial summary
This is a 64-patient, 90-day, open -label study on adult patients undergoing below knee amputation for various etiologies. The objective of this study is to assess surgical wound healing and wound bioburden using combination treatment of Next Science SurgX™ Antimicrobial Wound Gel and BlastX™ Antimicrobial Wound Gels… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound, Surgical Site Infection, Surgical Wound Infection
- What is being tested?
- Next Science Wounds Gels
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Male or non-pregnant female 18 years or older
- Participant must be undergoing below the knee amputation with primary closure or completion below the knee amputation with primary closure.
- There must be no infection present at the surgical incision site
- Participant is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period
- Must have a popliteal pressure on arterial doppler of 40 mm Hg or higher in the surgical leg or angiographic evidence of popliteal artery flow
- No known allergic reaction or sensitivity to investigational product or components
- Willing and able to comply with all study procedures including transportation to the study site for all scheduled visits and be available for the duration of the study
- Provide signed and dated informed consent
Who cannot join
- Male or Female less than 18 years old
- Pregnancy as determined by pre-op urine hCG testing on the day of surgery for women of childbearing potential (women are considered clinically post-menopausal if over 12 consecutive months without a menstrual period)
- Systemic sepsis at the time of surgery
- Disseminated Cancer Patients
- Current long-term (more than 30 consecutive days) use of moderate or high dose oral corticosteroids
- Current long-term (more than 30 consecutive days) use of immune modulators/suppressors
Show all 12Show fewer
- Known sensitivity to investigational product or any components
- Participants with HIV or acquired immunodeficiency syndrome (AIDS) or any other immunodeficient states
- Any disease or prior/planned surgery or other situation that in the investigator's opinion may interfere with the participant successfully completing the study.
- Overlapping participation in another treatment or interventional clinical trial.
- Family members or students of the Investigator or clinical site.
- Safety exclusion criterion: At the end of the procedure, the surgeon and PI can discuss to withdraw the patient, if it is felt that continuing in the study will be detrimental to the patient. For example, if the incision cannot be closed, or if it requires a muscle flap, or if the incision site encounters contamination or infection not recognized prior to the start of surgery. The decision to withdraw the patient will be made in the OR, prior to being randomized.
About this study
Official title: Clinical Assessment of the Next Science BlastXTM Antimicrobial Gel and SurgXTM Antimicrobial Gel Healing Efficacy for Below the Knee Amputation Surgical Wound Compared to Standard of Care
This is a 64-patient, 90-day, open -label study on adult patients undergoing below knee amputation for various etiologies. The objective of this study is to assess surgical wound healing and wound bioburden using combination treatment of Next Science SurgX™ Antimicrobial Wound Gel and BlastX™ Antimicrobial Wound Gels as compared to standard of care.
Read the detailed description
This is a prospective, randomized, 90 day, open-label study of patients undergoing below the knee amputation (BKA) with primary closure or completion.
Patients who present for BKA with primary closure or completion will have had a pre-op medical evaluation prior to being screened against the protocol's inclusion/exclusion criteria. If criteria are met, patients will be presented with the option to participate in the study and informed consent procedures will be carried out, in compliance with currently applicable participants' rights and safety regulations.
A minimum of 64 participants, with up to 70 participants, may be enrolled. A participant requiring bilateral BKA will be excluded. Eligible subjects will need to complete the study to meet the primary endpoint.
It is estimated that the study enrollment period will last approximately eighteen months, and the duration of each participants' participation will be three months. Visits in the treatment portion of the study will be carried out at day 0, 3, 14, 21, and 28 days with a scheduling window of 3 days before or after each due date. A phone call follow-up will be conducted at 60 days post-surgery with a window of 7 days before or 14 days after to inquire about the incision (appearance of incision or any noted changes since prior study visit), and overall health of the participant. All participants, regardless of treatment arm, will complete Visit 6 (90 day follow up) with a scheduling window of 7 days before or 21 days after. The key parameters of the study include: percentage of surgical wound area reduction, time patients are deemed ready prosthetic healing, and microorganism type and amounts. Bacterial identification and quantification will occur at days 0, 14, and 28 for all participants.
- Conditions
- Surgical Wound, Surgical Site Infection, Surgical Wound Infection, Amputation Stump; Infection, Surgical Incision
- Being tested
- Next Science Wounds Gels
- Keywords
- BKA, biofilm, Next Science
- Medical subject headings
- Surgical Wound, Surgical Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Science Wounds GelsDevice
SurgX will be applied once at closure while BlastX will be applied everyday until day 28 with each dressing change.
| Study group | Role | What they receive |
|---|---|---|
| Next Science | Experimental | Following amputation, SurgX™ will be applied directly to the surgical incision in the operating room under sterile conditions and covered with SOC dressing. The surgical dressing will not be removed until post-operative day 3, except if deemed necessary by the treating surgeon. At that time, direct application of the BlastX™ to the incision will be placed, then covered with a SOC dressing. BlastX™ will be applied every day and covered with SOC dressing. Receives: Device: Next Science Wounds Gels |
| Control | No intervention | Post-op SOC dressing as per treating research doctor to include dressing changes post-op day 3 and daily thereafter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Incisional Wound Area Change
Incisional wounds treated with SurgX™, BlastX™ and SOC Treatment will have higher percentage of area reduction than SOC alone after 28 days of treatment.
Measured: 28 Days
Time to when Patient is Ready for Prosthetic Fitting
Participants treated with SurgX™, BlastX™ and SOC treatment will be deemed ready to be fitted with a prosthetic limb earlier (days) than those in the SOC Control Group.
Measured: Day 0 to 90 Days
Secondary outcomes (4)
Bioburden
The amount of viable microorganisms persisting in wounds (CFU) treated with SurgX™, BlastX™ and SOC treatment will be less than those in the SOC Control Group at one or more of the measured time points.
Measured: Day 0, Day 14, Day 28
Bioburden
The semi-quantitative amount of DNA measured microorganisms persisting in wounds treated with SurgX™, BlastX™ and SOC will be less when compared to the SOC Control Group at one or more of the measured time points.
Measured: Day 0, Day 14, Day 28
Bioburden
The number of DNA measured microorganisms persisting in wounds treated with SurgX™, BlastX™ and SOC treatment will be less when compared to the SOC Control Group at one or more of the measured time points.
Measured: Day 0, Day 14, Day 28
Wound Area Reduction
Percentage of surgical wound area change after treatment with SurgX™ at the time of the procedure plus 14 and 21 days of treatment with BlastX™ wound gel compared to SOC.
Measured: Baseline to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Why it stopped: Site backed out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Next Science TM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore
- Responsible party
- Sponsor
- Investigators
- Khanjan H Nagarsheth, MD, MBA, FACS, RPVI, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053946
- Sponsor's protocol ID
- CSP-012
- Status last verified
- Apr 2023
- First submitted
- 9 Aug 2019
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of the Next Science BlastXTM Antimicrobial Gel and SurgXTM Antimicrobial Gel Healing Efficacy for Below the Knee Amputation Surgical Wound Compared to Standard of Care
- ClinicalTrials.gov ID
- NCT04053946
- Acronym / sponsor ID
- CSP-012
- Conditions
- Surgical Wound, Surgical Site Infection, Surgical Wound Infection, Amputation Stump; Infection, Surgical Incision
- Keywords
- BKA, biofilm, Next Science
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Site backed out
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Next Science TMIndustry (pharma, biotech, devices)
- Collaborators
- University of Maryland, Baltimore
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 13 Aug 2019 (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.
This is a 64-patient, 90-day, open -label study on adult patients undergoing below knee amputation for various etiologies. The objective of this study is to assess surgical wound healing and wound bioburden using combination treatment of Next Science SurgX™ Antimicrobial Wound Gel and BlastX™ Antimicrobial Wound Gels as compared to standard of care.
Detailed description
This is a prospective, randomized, 90 day, open-label study of patients undergoing below the knee amputation (BKA) with primary closure or completion.
Patients who present for BKA with primary closure or completion will have had a pre-op medical evaluation prior to being screened against the protocol's inclusion/exclusion criteria. If criteria are met, patients will be presented with the option to participate in the study and informed consent procedures will be carried out, in compliance with currently applicable participants' rights and safety regulations.
A minimum of 64 participants, with up to 70 participants, may be enrolled. A participant requiring bilateral BKA will be excluded. Eligible subjects will need to complete the study to meet the primary endpoint.
It is estimated that the study enrollment period will last approximately eighteen months, and the duration of each participants' participation will be three months. Visits in the treatment portion of the study will be carried out at day 0, 3, 14, 21, and 28 days with a scheduling window of 3 days before or after each due date. A phone call follow-up will be conducted at 60 days post-surgery with a window of 7 days before or 14 days after to inquire about the incision (appearance of incision or any noted changes since prior study visit), and overall health of the participant. All participants, regardless of treatment arm, will complete Visit 6 (90 day follow up) with a scheduling window of 7 days before or 21 days after. The key parameters of the study include: percentage of surgical wound area reduction, time patients are deemed ready prosthetic healing, and microorganism type and amounts. Bacterial identification and quantification will occur at days 0, 14, and 28 for all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Next Science | Experimental | Device: Next Science Wounds GelsFollowing amputation, SurgX™ will be applied directly to the surgical incision in the operating room under sterile conditions and covered with SOC dressing. The surgical dressing will not be removed until post-operative day 3, except if deemed necessary by the treating surgeon. At that time, direct application of the BlastX™ to the incision will be placed, then covered with a SOC dressing. BlastX™ will be applied every day and covered with SOC dressing. |
| Control | No intervention | –Post-op SOC dressing as per treating research doctor to include dressing changes post-op day 3 and daily thereafter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or non-pregnant female 18 years or older
- Participant must be undergoing below the knee amputation with primary closure or completion below the knee amputation with primary closure.
- There must be no infection present at the surgical incision site
- Participant is determined to NOT require endovascular or vascular reconstructive surgery to restore blood flow to the wound within the study period
- Must have a popliteal pressure on arterial doppler of 40 mm Hg or higher in the surgical leg or angiographic evidence of popliteal artery flow
Key exclusion criteria (12 listed)
- Male or Female less than 18 years old
- Pregnancy as determined by pre-op urine hCG testing on the day of surgery for women of childbearing potential (women are considered clinically post-menopausal if over 12 consecutive months without a menstrual period)
- Systemic sepsis at the time of surgery
- Disseminated Cancer Patients
- Current long-term (more than 30 consecutive days) use of moderate or high dose oral corticosteroids
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 |
|---|---|---|
| Next Science Wounds GelsSurgX will be applied once at closure while BlastX will be applied everyday until day 28 with each dressing change. | Device | Next Science |
Primary outcome
Percentage of Incisional Wound Area Change
Time frame: 28 Days
Incisional wounds treated with SurgX™, BlastX™ and SOC Treatment will have higher percentage of area reduction than SOC alone after 28 days of treatment.
Time to when Patient is Ready for Prosthetic Fitting
Time frame: Day 0 to 90 Days
Participants treated with SurgX™, BlastX™ and SOC treatment will be deemed ready to be fitted with a prosthetic limb earlier (days) than those in the SOC Control Group.
4 secondary outcomes
Bioburden
Time frame: Day 0, Day 14, Day 28
Bioburden
Time frame: Day 0, Day 14, Day 28
Bioburden
Time frame: Day 0, Day 14, Day 28
Wound Area Reduction
Time frame: Baseline to 21 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- 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. This study is not recruiting at the moment.
Khanjan H Nagarsheth, MD, MBA, FACS, RPVI principal investigator
University of Maryland
Questions about this trial
What is this clinical trial studying?
A study testing Next Science Wounds Gels in people with Surgical Wound and Surgical Site Infection, run by Next Science TM.
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 12 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: withdrawn, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percentage of Incisional Wound Area Change (time frame: 28 Days). The study lists 2 primary outcomes in all. 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 19 Apr 2023.