An interventional study of Next Science Wounds Gels in Surgical Wound, Surgical Site Infection and Surgical Wound Infection, sponsored by Next Science TM. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Next Science TM · Not applicable, Interventional, and Treatment
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.
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.
315 studies on the registry are indexed under Surgical Wound; 57 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Next Science Wounds Gels
Post-op SOC dressing as per treating research doctor to include dressing changes post-op day 3 and daily thereafter.
SurgX will be applied once at closure while BlastX will be applied everyday until day 28 with each dressing change.
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.
Time frame: 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.
Time frame: Day 0 to 90 Days
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 21 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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