A Comparison Between Two Post-operative Dressings

NCT04888624 | Completed FDA Device

• 1 other identifier: DRYSEE-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Incision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The effectiveness of liquid indication in identifying dressing compromise by visual assessment

  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.

  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.

  6-weeks

• A comparison of adverse events between the two treatment arms.

  6-weeks

Other Outcomes (1)

• A comparison of bacterial burden beneath the two dressings measured by fluorescence imaging (MolecuLight, Toronto, CA).

  6-weeks

Study Arms (2)

DrySee® dressing with moisture detection

EXPERIMENTAL

DrySee® dressing with moisture detection

Device: DrySee® dressing with moisture detection

Tegaderm® + Pad transparent film dressing

ACTIVE COMPARATOR

Tegaderm® + Pad transparent film dressing

Device: Tegaderm® + Pad transparent film dressing

Interventions

DrySee® dressing with moisture detection DEVICE

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.

DrySee® dressing with moisture detection

Tegaderm® + Pad transparent film dressing DEVICE

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.

Tegaderm® + Pad transparent film dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SerenaGroup, Inc.: lead
• DrySee, Inc: collaborator

Study Sites (1)

Serena Group Monroeville

Monroeville, Pennsylvania, 15146, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Thomas Serena, MD,FACS

  SerenaGroup, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: May 4, 2021
• First Posted: May 17, 2021
• Study Start: September 13, 2021
• Primary Completion: October 25, 2021
• Study Completion: February 1, 2022
• Last Updated: March 14, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)