Clinical trial NCT04888624: A Comparison Between Two Post-operative Dressings
Official title: A Comparison Between Two Post-operative Dressings in the Treatment of Surgical Incisions in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Incision
Lead sponsor: SerenaGroup, Inc.
Sponsor class: NETWORK
Collaborators: name: DrySee, Inc
First posted: 2021-05-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: A comparison of wear time between the two post-operative dressings under study.
timeFrame: 6-weeks
Secondary outcomes:
measure: The effectiveness of liquid indication in identifying dressing compromise by visual assessment
timeFrame: 6-weeks
measure: A comparison of dressing integrity between the two dressings under study if the dressings remains intact at the treatment visits by visual assessment.
timeFrame: 6-weeks
measure: 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.
timeFrame: 6-weeks
measure: A comparison of adverse events between the two treatment arms.
timeFrame: 6-weeks
Other outcomes:
measure: A comparison of bacterial burden beneath the two dressings measured by fluorescence imaging (MolecuLight, Toronto, CA).
timeFrame: 6-weeks
Locations:
city: Monroeville
country: United States
facility: Serena Group Monroeville
state: Pennsylvania
Study officials:
affiliation: SerenaGroup, Inc.
name: Thomas Serena, MD,FACS
role: PRINCIPAL_INVESTIGATOR
References: