A Comparison Between Two Post-operative Dressings

Surgical Incision Clinical Trial

— DrySee  

Official title:

A Comparison Between Two Post-operative Dressings in the Treatment of Surgical Incisions in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04888624
• Other study ID #: DRYSEE-001
• Status: Completed
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2022
• Source: SerenaGroup, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Healthy subjects drawn from the general population. will undergo a 1.5cm incision on the volar forearm of each arm. The incision will be closed with streriostrips. The subject's 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Surgical Incision
• Surgical Wound

Intervention

Device:
• DrySee® dressing with moisture detection
DrySee® is a waterproof bandage designed to protect surgical incisions. It contains an indicator at the perimeter of the dressing, and at the wound site that turns blue when it comes into contact with liquid (figure 1). The indicator identifies a break in the integrity of the postoperative dressing. Changing the dressing at this point prevents bacteria from reaching the incision reducing the risk of infection. In addition, the waterproof dressing allows patients to shower or bath following surgery.
• Tegaderm® + Pad transparent film dressing
Tegaderm® is a transparent adhesive dressing commonly used as a postoperative dressing. The dressing has been shown to be superior to gauze in reducing SSIs. Tegaderm®, like DrySee,® is waterproof; however, it lacks technology that identifies a breach in dressing integrity.

Locations

Country	Name	City	State
United States	Serena Group Monroeville	Monroeville	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
SerenaGroup, Inc.	DrySee, Inc

Country where clinical trial is conducted

United States, 

Outcome

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