Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04888624
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2021-05-04
Brief Title:
A Comparison Between Two Post-operative Dressings
Sponsor:
SerenaGroup Inc
Organization:
SerenaGroup Inc
Study Overview
Official Title:
A Comparison Between Two Post-operative Dressings in the Treatment of Surgical Incisions in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DrySee
Brief Summary:
Surgical site infections are one of the leading causes of post-operative morbidity and mortality worldwide The ideal post-operative dressing is impermeable and remains intact preventing contamination of the incision with microorganisms In addition it is often difficult for the patient to identify breaks in dressing integrity This trial compares a post-operative dressing DrySee Inc Houston Tx with moisture detection allowing the patient to recognize when the dressing is compromised to a standard post-operative dressing Tegaderm Pad 3M St Paul MN The ideal dressing also allows the patient to shower without removing the dressing
Detailed Description:
Healthy subjects drawn from the general population will undergo a 15cm incision on the volar forearm of each arm The incision will be closed with streriostrips The subjects incisions will then be randomized to receive either a Tegaderm Pad transparent film dressing or DrySee dressing with moisture detection The incisions will be photographed three times per week Data on dressing wear time integrity and adverse events will be collected every two days in the clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None