Clinical trial NCT02591537: OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds
Lead sponsor: Halyard Health
Sponsor class: INDUSTRY
Collaborators: name: Northwestern University
First posted: 2015-10-29
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Healing in Days.
timeFrame: 14 days
Secondary outcomes:
measure: Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding.
timeFrame: Day 14
measure: Pain on Test Versus Control Side Using a Wong-Baker Scale.
timeFrame: Day 14
measure: Biopsy & Histology of Wounds.
timeFrame: Day 28
measure: Scar Quality Analysis; Modified Vancouver Scar Scale (MVS)
timeFrame: Day 42
measure: Scar Quality Analysis; Visual Analogue Scale
timeFrame: Day 42
measure: Scar Quality Analysis; Elastometer
timeFrame: Day 42
measure: Scar Quality Analysis; Colorimeter
timeFrame: Day 42
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Robert Galiano, MD
role: PRINCIPAL_INVESTIGATOR
References: