Surgical Incision Clinical Trial
— DrySeeOfficial title:
A Comparison Between Two Post-operative Dressings in the Treatment of Surgical Incisions in Healthy Volunteers
Verified date | March 2022 |
Source | SerenaGroup, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 1, 2022 |
Est. primary completion date | October 25, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. At least 18 years old. 2. Subject has read, understood, and signed approved consent, and is willing to participate and comply with the study procedures and requirements. Exclusion Criteria: 1. Subject on an investigational drug or therapeutic device within 30 days of the study visit. 2. Presence of a condition that PI considers will compromise the subject's ability to participate in the study. 3. Known allergy to any of the dressings or their components. 4. The subject has a history of excessive bleeding. 5. The subject has a history of keloid formation. |
Country | Name | City | State |
---|---|---|---|
United States | Serena Group Monroeville | Monroeville | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
SerenaGroup, Inc. | DrySee, Inc |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | A comparison of bacterial burden beneath the two dressings measured by fluorescence imaging (MolecuLight, Toronto, CA). | A comparison of bacterial burden beneath the two dressings measured by fluorescence imaging (MolecuLight, Toronto, CA). | 6-weeks | |
Primary | A comparison of wear time between the two post-operative dressings under study. | A comparison of wear time between the two post-operative dressings under study. | 6-weeks | |
Secondary | The effectiveness of liquid indication in identifying dressing compromise by visual assessment | The effectiveness of liquid indicator of the dressing turning blue | 6-weeks | |
Secondary | A comparison of dressing integrity between the two dressings under study if the dressings remains intact at the treatment visits by visual assessment. | A comparison of dressing integrity between the two dressings under study if the dressings remains intact at the treatment visits by visual assessment. | 6-weeks | |
Secondary | A comparison between the two dressings to maintain waterproof protection of the incision by visual assessment if there was a break in the dressing border. | A comparison between the two dressings to maintain waterproof protection of the incision by visual assessment of if there was a break in the dressing border at each treatment visit. | 6-weeks | |
Secondary | A comparison of adverse events between the two treatment arms. | A comparison of adverse events between the two treatment arms. | 6-weeks |
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