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Completed

NCT Number: NCT04888624

A Comparison Between Two Post-operative Dressings

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.

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Key information

Conditions

Surgical Incision Surgical Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Serena Group Monroeville

Monroeville, Pennsylvania, 15146, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. A comparison of wear time between the two post-operative dressings under study.

    Time frame: 6-weeks

    A comparison of wear time between the two post-operative dressings under study.

Secondary outcomes

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

    Time frame: 6-weeks

    The effectiveness of liquid indicator of the dressing turning blue

  2. A comparison of dressing integrity between the two dressings under study if the dressings remains intact at the treatment visits by visual assessment.

    Time frame: 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.

  3. 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.

    Time frame: 6-weeks

    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.

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

    Time frame: 6-weeks

    A comparison of adverse events between the two treatment arms.

Other outcomes

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

    Time frame: 6-weeks

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

Sponsors and collaborators

Lead sponsor

SerenaGroup, Inc.

Network

Collaborators

  • DrySee, Inc

Registry information

Official study title

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

Acronym: DrySee

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 17, 2021
Registry last updated
Mar 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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