NCT04888624

A Comparison Between Two Post-operative Dressings

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: SerenaGroup, Inc. · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• Surgical Incision

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2021-09-13
• Primary completion: 2021-10-25
• Completion: 2022-02-01
• First posted: 2021-05-17
• Last updated: 2022-03-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study