A Comparison Between Two Post-operative Dressings (DrySee)

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

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.

Study Overview

• Status: Completed
• Conditions: Surgical Incision
• Intervention / Treatment: Device: DrySee® dressing with moisture detection; Device: Tegaderm® + Pad transparent film 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Monroeville, Pennsylvania, United States, 15146
      • Serena Group Monroeville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DrySee® dressing with moisture detection	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.
ACTIVE_COMPARATOR: Tegaderm® + Pad transparent film dressing	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effectiveness of liquid indication in identifying dressing compromise by visual assessment	The effectiveness of liquid indicator of the dressing turning blue	6-weeks
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
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
A comparison of adverse events between the two treatment arms.	A comparison of adverse events between the two treatment arms.	6-weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: SerenaGroup, Inc.
• Collaborators: DrySee, Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 13, 2021
• Primary Completion (ACTUAL): October 25, 2021
• Study Completion (ACTUAL): February 1, 2022

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (ACTUAL): May 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2022
• Last Update Submitted That Met QC Criteria: March 11, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: DRYSEE-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes