A Comparison Between Two Post-operative Dressings (DrySee)

SerenaGroup

Status

Completed

Conditions

Surgical Incision

Treatments

Device: DrySee® dressing with moisture detection

Device: Tegaderm® + Pad transparent film dressing

Study type

Interventional

Funder types

NETWORK

Other

Identifiers

NCT04888624

DRYSEE-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

At least 18 years old.
Subject has read, understood, and signed approved consent, and is willing to participate and comply with the study procedures and requirements.

Exclusion criteria

Subject on an investigational drug or therapeutic device within 30 days of the study visit.
Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
Known allergy to any of the dressings or their components.
The subject has a history of excessive bleeding.
The subject has a history of keloid formation.