Surgical IncisionDrySeeNCT04888624
A Comparison Between Two Post-operative Dressings
A study testing DrySee® dressing with moisture detection and Tegaderm® + Pad transparent film dressing in people with Surgical Incision, run by SerenaGroup, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Incision
- What is being tested?
- DrySee® dressing with moisture detection and Tegaderm® + Pad transparent film dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Serena Group Monroeville
Monroeville, Pennsylvania, 15146
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgical Incision
- Being tested
- DrySee® dressing with moisture detection, Tegaderm® + Pad transparent film dressing
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrySee® dressing with moisture detectionDevice
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 dressingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DrySee® dressing with moisture detection | Experimental | DrySee® dressing with moisture detection Receives: Device: DrySee® dressing with moisture detection |
| Tegaderm® + Pad transparent film dressing | Active comparator | Tegaderm® + Pad transparent film dressing Receives: Device: Tegaderm® + Pad transparent film dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-weeks
Secondary outcomes (4)
The effectiveness of liquid indication in identifying dressing compromise by visual assessment
The effectiveness of liquid indicator of the dressing turning blue
Measured: 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.
Measured: 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.
Measured: 6-weeks
A comparison of adverse events between the two treatment arms.
A comparison of adverse events between the two treatment arms.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start13 Sep 2021
- Primary completion25 Oct 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical IncisionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- SerenaGroup, Inc.
- Sponsor type
- Research network
- Collaborators
- DrySee, Inc
- Responsible party
- Sponsor
- Investigators
- Thomas Serena, MD,FACS, Principal investigator, SerenaGroup, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888624
- Sponsor's protocol ID
- DRYSEE-001
- Acronym
- DrySee
- Status last verified
- Mar 2022
- First submitted
- 4 May 2021
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Two Post-operative Dressings in the Treatment of Surgical Incisions in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04888624
- Acronym / sponsor ID
- DrySee / DRYSEE-001
- Conditions
- Surgical Incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- SerenaGroup, Inc.Research network
- Collaborators
- DrySee, Inc
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| DrySee® dressing with moisture detection | Experimental | Device: DrySee® dressing with moisture detectionDrySee® dressing with moisture detection |
| Tegaderm® + Pad transparent film dressing | Active comparator | Device: Tegaderm® + Pad transparent film dressingTegaderm® + Pad transparent film dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DrySee® dressing with moisture detectionDrySee® 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. | Device | DrySee® dressing with moisture detection |
| Tegaderm® + Pad transparent film dressingTegaderm® 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. | Device | Tegaderm® + Pad transparent film dressing |
Primary outcome
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.
4 secondary outcomes
The effectiveness of liquid indication in identifying dressing compromise 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.
Time frame: 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.
Time frame: 6-weeks
A comparison of adverse events between the two treatment arms.
Time frame: 6-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Serena, MD,FACS principal investigator
SerenaGroup, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DrySee® dressing with moisture detection and Tegaderm® + Pad transparent film dressing in people with Surgical Incision, run by SerenaGroup, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A comparison of wear time between the two post-operative dressings under study. (time frame: 6-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.