A Comparison Between Two Post-operative Dressings

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgical Incision

Intervention / Treatment
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* Device: DrySee® dressing with moisture detection
* Device: Tegaderm® + Pad transparent film dressing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DrySee® dressing with moisture detection<br>DrySee® dressing with moisture detection | Device: DrySee® dressing with moisture detection<br>* 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.<br>|
| Active Comparator: Tegaderm® + Pad transparent film dressing<br>Tegaderm® + Pad transparent film dressing | Device: Tegaderm® + Pad transparent film dressing<br>* 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.<br>|

What is the study measuring?
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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 |