OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University

NCT02591537 | Completed Results

• 1 other identifier: 100-15-0001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Secondary Outcomes (7)

• Wound Degree of Epithelialization Percent Change by Digital Photography at Each Time Point Post Wounding.

  Day 14

• Pain on Test Versus Control Side Using a Wong-Baker Scale.

  Day 14

• Biopsy & Histology of Wounds.

  Day 28

• Scar Quality Analysis; Modified Vancouver Scar Scale (MVS)

  Day 42

• Scar Quality Analysis; Visual Analogue Scale

  Day 42

Study Arms (2)

OxyGenesys Dissolved Oxygen Dressing

EXPERIMENTAL

OxyGenesys Dissolved Oxygen Dressing will be applied.

Device: OxyGenesys Dissolved Oxygen Dressing

Standard Tegaderm Dressing

NO INTERVENTION

Tegaderm will be applied.

Interventions

OxyGenesys Dissolved Oxygen Dressing DEVICE

1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.

OxyGenesys Dissolved Oxygen Dressing

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halyard Health: lead
• Northwestern University: collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Results Point of Contact

• Title: Dr. Robert Galiano, Associate Professor of Surgery
• Organization: Northwestern University

312.695.3908

Study Officials

• Robert Galiano, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 29, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 4, 2017
• Results First Posted: October 4, 2017

Record last verified: 2017-08

Locations

US (1)