NCT02591537

OxyGenesys Dissolved Oxygen Dressing; Abdominoplasty at Northwestern University

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Halyard Health · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Wounds

Interventions

Type	Name	Description
DEVICE	OxyGenesys Dissolved Oxygen Dressing	1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-10-29
• Last updated: 2017-10-04
• Results posted: 2017-10-04

Locations

1 site across 1 country: United States