WoundsNCT02591537
OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University
A study testing OxyGenesys Dissolved Oxygen Dressing in people with Wounds, run by Halyard Health at 1 site in United States.
Trial summary
Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound healing will be observed over 14 days. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Wounds
- What is being tested?
- OxyGenesys Dissolved Oxygen Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Sep 2016
- 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 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or non-pregnant females aged 21-85 years. Female subjects of child bearing potential must be using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dressing.
- Subject is willing to undergo the creation of twelve experimental donor sites 1.0" x 1.0" in size with a depth between 0.0012"-0.0018" taken from the abdomen per a modification of the Northwestern Abdominoplasty Scar Model
- Subjects who are medically acceptable candidates for abdominoplasty (BMI approximately 25-35 kg/m2) as determined by per-study laboratory assessment and clinical evaluation.
- Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration of the study.
Who cannot join
- Subjects who have received treatment with systemic steroids during the 30 days prior to study enrollment.
- Subjects who have received immunosuppressive drugs, radiation or chemotherapy during the three months prior to study enrollment.
- Subjects with a history of malignancy in the previous three years.
- Subjects with uncontrolled diabetes (A1C > 8%).
- Subjects who are current smokers or have any significant pack-year history of smoking (>1 pack-year).
- Subjects with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy.
Show all 15Show fewer
- Subjects who have previously had skin grafts harvested from the area to be studied.
- Subjects with a skin disorder (other than chronic venous ulcers) that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
- Subjects with extensive severe striae that would make it difficult to perform a skin graft on the abdomen and/or evaluate the final scar appearance.
- Subjects with a history of clinical significant hypersensitivity to any of the surgical dressings to be used in this trial.
- Subjects who are taking, or have taken any Investigational drugs within 3 months prior to the screening visit.
- Subjects who are participating in other research Investigations.
- Subjects requiring treatment with medications(s) that are known to interfere with wound healing.
- Subjects who are or who become pregnant up to and including Day 0 or who are lactating.
- Subjects who, in the opinion of the Investigator, are not likely to complete the trial for whatever reason, including significant comorbidities that may adversely affect survival or ability to attend follow up visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Prospective, Randomized, Single Center, Controlled Evaluation of the Effectiveness of OxyGenesys Topical Dissolved Oxygen Dressing in Accelerating the Healing of Split Thickness Skin Graft Donor Sites Using the NWU Abdominoplasty Scar Model
Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound healing will be observed over 14 days.
Read the detailed description
At least 12 study visits will occur over a 3 month timeframe. Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound healing will be observed over 14 days (follow up assessments include wound photography, pain scores, wound biopsies, exudate collection, gene expression and proteomic analysis, scar assessment and adverse event collections. Study visits will occur at:
Prescreening Visit; Day of wounding; Day 2; Day 7; Day 8-14 (until all wounds have healed); Day 28; Day 42; Abdominoplasty Surgery. An abdominoplasty will occur after day 42.
- Conditions
- Wounds
- Being tested
- OxyGenesys Dissolved Oxygen Dressing
- 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.
OxyGenesys Dissolved Oxygen DressingDevice
1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.
| Study group | Role | What they receive |
|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Experimental | OxyGenesys Dissolved Oxygen Dressing will be applied. Receives: Device: OxyGenesys Dissolved Oxygen Dressing |
| Standard Tegaderm Dressing | No intervention | Tegaderm will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing in Days.
Wound healing will be defined as 90% re-epithelialization. Mean time to healing will be compared between the OxyGenesys treated sites and the control treated sites.
Measured: 14 days
Secondary outcomes (7)
Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding.
Wound degree of epithelialization percent change by digital photography at day 14.
Measured: Day 14
Pain on Test Versus Control Side Using a Wong-Baker Scale.
Subjects will report pain level on each side of their abdomen at day 14. The Wong-Baker scale is: 0 points = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst. A grand mean and standard deviation (reported below) were determined by combining participant scores.The identical group mean and standard deviation values reported below are correct.
Measured: Day 14
Biopsy & Histology of Wounds.
Biopsies will be taken from all wounds at day 28. Analysis of tissue samples will specifically evaluate differences and rates of collagen deposition, angiogenesis and re-epithelialization between the two study arms.
Measured: Day 28
Scar Quality Analysis; Modified Vancouver Scar Scale (MVS)
Scar quality will be assessed and analyzed between the two groups using the Modified Vancouver Scar Scale at day 42. The MVS assessment is the tool that the Investigator will use to evaluate scar pliability (0 points = normal, 1 = supple, 2 = yielding, 3 = firm, 4 = adherent), height (0 = normal, 1 = 1-2 mm, 2 = 3-4 mm, 3 = 5-6 mm, 4 = > 6 mm), vascularity (0 = normal, 1 = pink, 2 = red, 3 = purple), and pigmentation (0 = normal, 1 = slight, 2 = moderately, 3 = severely). An average score for each participant was calculated by combining scores from each subscale. Average participant scores in each study group were combined to produce a grand mean and standard deviation for each group (reported below).
Measured: Day 42
Scar Quality Analysis; Visual Analogue Scale
Scar quality of each study participant was assessed by using the Visual Analogue Scale (VAS) at day 42. The VAS is an 11-point scale that ranges from 0 (normal skin) to 10 (worst possible scar). The values on the scale indicate the observer's global impression of the scar (lower numbers are better than higher numbers).
Measured: Day 42
Scar Quality Analysis; Elastometer
Scar quality was to be assessed for each study participant using an elastometer at day 42. An elastometer is used to assess scar elasticity. Unfortunately, the data for this study endpoint were not collected properly, and despite our best efforts, there is no way to resolve this issue. Thus, no data can be reported for this study outcome.
Measured: Day 42
Scar Quality Analysis; Colorimeter
Scar quality was to be assessed for each study participant using a colorimeter at day 42. A colorimeter was to be used to measure the extent of erythema, and melanin content, of the skin. Unfortunately, the data for this study endpoint were not collected properly, and despite our best efforts, there is no way to resolve this issue. Thus, no data can be reported for this study outcome.
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2016
- Study completionSep 2016
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 WoundsStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halyard Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
- Investigators
- Robert Galiano, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591537
- Sponsor's protocol ID
- 100-15-0001
- Status last verified
- Aug 2017
- First submitted
- 12 Oct 2015
- Last updated
- 4 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Single Center, Controlled Evaluation of the Effectiveness of OxyGenesys Topical Dissolved Oxygen Dressing in Accelerating the Healing of Split Thickness Skin Graft Donor Sites Using the NWU Abdominoplasty Scar Model
- ClinicalTrials.gov ID
- NCT02591537
- Acronym / sponsor ID
- 100-15-0001
- Conditions
- Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Halyard HealthIndustry (pharma, biotech, devices)
- Collaborators
- Northwestern University
- Study start
- Oct 2015 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Posted 4 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound healing will be observed over 14 days.
Detailed description
At least 12 study visits will occur over a 3 month timeframe. Twelve acute wounds (6 on either side of the umbilicus) will be surgically created in the lower abdominal area. One side of the umbilicus will be randomized to Oxygenesys treatment arm and the other side will be receiving a standard Tegaderm treatment arm. Time to wound healing will be observed over 14 days (follow up assessments include wound photography, pain scores, wound biopsies, exudate collection, gene expression and proteomic analysis, scar assessment and adverse event collections. Study visits will occur at:
Prescreening Visit; Day of wounding; Day 2; Day 7; Day 8-14 (until all wounds have healed); Day 28; Day 42; Abdominoplasty Surgery. An abdominoplasty will occur after day 42.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing | Experimental | Device: OxyGenesys Dissolved Oxygen DressingOxyGenesys Dissolved Oxygen Dressing will be applied. |
| Standard Tegaderm Dressing | No intervention | –Tegaderm will be applied. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males or non-pregnant females aged 21-85 years. Female subjects of child bearing potential must be using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dressing.
- Subject is willing to undergo the creation of twelve experimental donor sites 1.0" x 1.0" in size with a depth between 0.0012"-0.0018" taken from the abdomen per a modification of the Northwestern Abdominoplasty Scar Model
- Subjects who are medically acceptable candidates for abdominoplasty (BMI approximately 25-35 kg/m2) as determined by per-study laboratory assessment and clinical evaluation.
- Willingness to provide informed consent and to comply with the requirements of this protocol for the full duration of the study.
Key exclusion criteria (15 listed)
- Subjects who have received treatment with systemic steroids during the 30 days prior to study enrollment.
- Subjects who have received immunosuppressive drugs, radiation or chemotherapy during the three months prior to study enrollment.
- Subjects with a history of malignancy in the previous three years.
- Subjects with uncontrolled diabetes (A1C > 8%).
- Subjects who are current smokers or have any significant pack-year history of smoking (>1 pack-year).
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 |
|---|---|---|
| OxyGenesys Dissolved Oxygen Dressing1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing. | Device | OxyGenesys Dissolved Oxygen Dressing |
Primary outcome
Healing in Days.
Time frame: 14 days
Wound healing will be defined as 90% re-epithelialization. Mean time to healing will be compared between the OxyGenesys treated sites and the control treated sites.
7 secondary outcomes
Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding.
Time frame: Day 14
Pain on Test Versus Control Side Using a Wong-Baker Scale.
Time frame: Day 14
Biopsy & Histology of Wounds.
Time frame: Day 28
Scar Quality Analysis; Modified Vancouver Scar Scale (MVS)
Time frame: Day 42
Scar Quality Analysis; Visual Analogue Scale
Time frame: Day 42
Scar Quality Analysis; Elastometer
Time frame: Day 42
Scar Quality Analysis; Colorimeter
Time frame: Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- 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.
Robert Galiano, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OxyGenesys Dissolved Oxygen Dressing in people with Wounds, run by Halyard Health 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 4 inclusion and 15 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 4 Oct 2017. 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?
Yes. Results are posted in the registry (first posted 4 Oct 2017). 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?
Healing in Days. (time frame: 14 days). 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 4 Oct 2017.