Total Hip ArthroplastyNCT05517278
Clinical Evaluation of the Next Science SurgX Antimicrobial Wound Gel Impact on Surgical Site Complications
A study testing SurgX Antimicrobial Wound Gel in people with Total Hip Arthroplasty and Total Knee Arthroplasty, run by Northwell Health at 3 sites in United States.
Trial summary
This is a single-site, prospective, clinical study of subjects that are scheduled to undergo either total hip or total knee arthroplasties. It is anticipated that surgical wounds treated with SurgX will exhibit reduced surgical site complication rates and improved post-operative treatment outcomes by potentially… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Hip Arthroplasty, Total Knee Arthroplasty
- What is being tested?
- SurgX Antimicrobial Wound Gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2024to 15 Jul 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female 18 years or older
- Scheduled to undergo primary hip or knee arthroplasty
- Willing and able to comply with all study procedures and be available for the duration of the study
- Provide signed and dated informed consent
Who cannot join
- Unable to provide signed and dated informed consent
- Unable or unwilling to comply with all study-related procedures
- Known history of allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings)
- Subject with any mental impairment or condition that would make them unable to properly consent without use of LAR or additional subject protections
- Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D
Trial locations and contacts
3 sites in 1 country.
United States3 sites
North Shore University Hospital
Manhasset, New York, 11030
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Lenox Hill Hospital
New York, New York, 10075
About this study
This is a single-site, prospective, clinical study of subjects that are scheduled to undergo either total hip or total knee arthroplasties. It is anticipated that surgical wounds treated with SurgX will exhibit reduced surgical site complication rates and improved post-operative treatment outcomes by potentially decreasing site bioburden of both free-floating and biofilm-entrenched organisms.
- Conditions
- Total Hip Arthroplasty, Total Knee Arthroplasty
- Being tested
- SurgX Antimicrobial Wound Gel, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgX Antimicrobial Wound GelOther
In addition to standard of care, at time of surgery, SurgX applied on the incision after closure and then re-applied at the time of first bandage change on day of discharge.
Standard of CareOther
The control group will receive standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The treatment group will receive SurgX™ Antimicrobial Wound Gel™ applied over incision after closure and then re-applied at first dressing change on day of discharge in addition to standard of care. Receives: Other: SurgX Antimicrobial Wound Gel |
| Control Group | Other | The control group will receive standard of care. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site complication
Presence/absence of a surgical site complication. Surgical site complications to be defined as meeting at least one of the below criteria:
- Bacterial or fungal infection as confirmed by PCR swabs
- Hypertrophic scar formation as diagnosed by in-person assessment via the study investigator
- Superficial granuloma formation as diagnosed by in-person assessment via study investigator
- Wound dehiscence as diagnosed by in-person assessment via study investigator
- Presence of discharge as diagnosed by in-person assessment via study investigator
- Presence of wound redness as diagnosed by in-person assessment via study investigator
- Presence of stitch abscess as diagnosed by in-person assessment via study investigator
- Superficial surgical site infection as diagnosed by in-person assessment via study investigator in accordance with the NHSN SSI Checklist
Measured: within 12 weeks of the index procedure
Secondary outcomes (1)
Wound images
Third party assessment of wound images taken with Tissue Analytics via blinded assessor to corroborate the investigator's assessment using the below criteria:
- Hypertrophic scar formation
- Superficial granulation
- Wound dehiscence
- Discharge
- Wound redness
- Stitch abscess
Measured: 12 weeks after index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study startJan 2024 (estimated)
- Primary completion15 Jul 2024
- Study completion15 Jul 2024
Why it stopped: Funding no longer available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Next Science TM
- Responsible party
- Principal investigator, Giles Scuderi, Northwell Health
- Investigators
- Giles Scuderi, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517278
- Sponsor's protocol ID
- 21-1050
- Status last verified
- May 2025
- First submitted
- 24 Aug 2022
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gronbeck C, Cote MP, Lieberman JR, Halawi MJ. Risk stratification in primary total joint arthroplasty: the current state of knowledge. Arthroplast Today. 2019 Feb 5;5(1):126-131. doi: 10.1016/j.artd.2018.10.002. eCollection 2019 Mar.
PubMed 31020036Doyle DJ, Goyal A, Bansal P, et al. American Society of Anesthesiologists Classification. [Updated 2020 Jul 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK441940/
Moonesinghe SR, Mythen MG, Das P, Rowan KM, Grocott MP. Risk stratification tools for predicting morbidity and mortality in adult patients undergoing major surgery: qualitative systematic review. Anesthesiology. 2013 Oct;119(4):959-81. doi: 10.1097/ALN.0b013e3182a4e94d.
PubMed 24195875Bilimoria KY, Liu Y, Paruch JL, Zhou L, Kmiecik TE, Ko CY, Cohen ME. Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons. J Am Coll Surg. 2013 Nov;217(5):833-42.e1-3. doi: 10.1016/j.jamcollsurg.2013.07.385. Epub 2013 Sep 18.
PubMed 24055383
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Next Science SurgX Antimicrobial Wound Gel Impact on Surgical Site Complications
- ClinicalTrials.gov ID
- NCT05517278
- Acronym / sponsor ID
- 21-1050
- Conditions
- Total Hip Arthroplasty, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding no longer available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Next Science TM
- Study start
- Jan 2024 (estimated)
- Primary completion
- 15 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 26 Aug 2022 (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 single-site, prospective, clinical study of subjects that are scheduled to undergo either total hip or total knee arthroplasties. It is anticipated that surgical wounds treated with SurgX will exhibit reduced surgical site complication rates and improved post-operative treatment outcomes by potentially decreasing site bioburden of both free-floating and biofilm-entrenched organisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: SurgX Antimicrobial Wound GelThe treatment group will receive SurgX™ Antimicrobial Wound Gel™ applied over incision after closure and then re-applied at first dressing change on day of discharge in addition to standard of care. |
| Control Group | Other | Other: Standard of CareThe control group will receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female 18 years or older
- Scheduled to undergo primary hip or knee arthroplasty
- Willing and able to comply with all study procedures and be available for the duration of the study
- Provide signed and dated informed consent
Key exclusion criteria (5 listed)
- Unable to provide signed and dated informed consent
- Unable or unwilling to comply with all study-related procedures
- Known history of allergic reaction to any of the study products or its components, including any products used for standard of care (such as dressings or any coverings)
- Subject with any mental impairment or condition that would make them unable to properly consent without use of LAR or additional subject protections
- Subjects from a vulnerable population, in accordance with 45 CFR 46 Subparts B, C, and D
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 |
|---|---|---|
| SurgX Antimicrobial Wound GelIn addition to standard of care, at time of surgery, SurgX applied on the incision after closure and then re-applied at the time of first bandage change on day of discharge. | Other | Treatment Group |
| Standard of CareThe control group will receive standard of care. | Other | Control Group |
Primary outcome
Surgical site complication
Time frame: within 12 weeks of the index procedure
Presence/absence of a surgical site complication. Surgical site complications to be defined as meeting at least one of the below criteria: 1. Bacterial or fungal infection as confirmed by PCR swabs 2. Hypertrophic scar formation as diagnosed by in-person assessment via the study investigator 3. Superficial granuloma formation as diagnosed by in-person assessment via study investigator 4. Wound dehiscence as diagnosed by in-person assessment via study investigator 5. Presence of discharge as diagnosed by in-person assessment via study investigator 6. Presence of wound redness as diagnosed by in-person assessment via study investigator 7. Presence of stitch abscess as diagnosed by in-person assessment via study investigator 8. Superficial surgical site infection as diagnosed by in-person assessment via study investigator in accordance with the NHSN SSI Checklist
1 secondary outcome
Wound images
Time frame: 12 weeks after index procedure
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 23 May 2025.
- Background: PubMed 31020036Gronbeck C, Cote MP, Lieberman JR, Halawi MJ. Risk stratification in primary total joint arthroplasty: the current state of knowledge. Arthroplast Today. 2019 Feb 5;5(1):126-131. doi: 10.1016/j.artd.2018.10.002. eCollection 2019 Mar.
- BackgroundDoyle DJ, Goyal A, Bansal P, et al. American Society of Anesthesiologists Classification. [Updated 2020 Jul 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK441940/
- Background: PubMed 24195875Moonesinghe SR, Mythen MG, Das P, Rowan KM, Grocott MP. Risk stratification tools for predicting morbidity and mortality in adult patients undergoing major surgery: qualitative systematic review. Anesthesiology. 2013 Oct;119(4):959-81. doi: 10.1097/ALN.0b013e3182a4e94d.
- Background: PubMed 24055383Bilimoria KY, Liu Y, Paruch JL, Zhou L, Kmiecik TE, Ko CY, Cohen ME. Development and evaluation of the universal ACS NSQIP surgical risk calculator: a decision aid and informed consent tool for patients and surgeons. J Am Coll Surg. 2013 Nov;217(5):833-42.e1-3. doi: 10.1016/j.jamcollsurg.2013.07.385. Epub 2013 Sep 18.
- 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.
Giles Scuderi principal investigator
Northwell Health
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SurgX Antimicrobial Wound Gel in people with Total Hip Arthroplasty and Total Knee Arthroplasty, run by Northwell Health at 3 sites 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 4 inclusion and 5 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 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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?
Surgical site complication (time frame: within 12 weeks of the index procedure). 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 NCT05517278, which also lists 4 linked publications.
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 23 May 2025.