Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02781779|
Recruitment Status : Completed
First Posted : May 24, 2016
Last Update Posted : May 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infections Wounds and Injuries||Device: Silverlon® Device: AQUACEL® AG||Phase 4|
This is a single center, prospective, 2-arm randomized, non-blinded study. A total of 100 participants will be assigned to the Silverlon arm and 100 to the AQUACEL AG arm.
The number of procedures to implant CIED has risen in recent years. With this rise has also brought a rise in post-procedure infections. Infections will happen and there is a continued need to improve all aspects of the surgery and post-operative care. Wound coverage with appropriate dressings is one aspect that needs to be studied in CIED implant patients. Silverlon and AQUACEL AG are two options of dressings available for these patients. This study will look to see if one of the two is a better option for post-operative CIED implant patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Active Comparator: Silverlon®
Subjects randomized to this arm will receive Silverlon® dressing postoperative.
Silverlon wound dressings
Active Comparator: AQUACEL® AG
Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative.
Device: AQUACEL® AG
AQUACEL® AG wound dressings
- Post-operative wound infections [ Time Frame: 10 days ]Number of post-operative wound infections
- Traumatic skin tears [ Time Frame: At time of dressing removal, up to 10 days post operative ]Count of traumatic skin tears at the time of wound dressing removal
- Pain score of wound dressing removal [ Time Frame: At time of dressing removal, up to 10 days post operative ]Pain will be reported by subject using a scale. Scores on the scale range from 1 to 10.
- Ease of removal of wound dressing [ Time Frame: At time of dressing removal, up to 10 days post operative ]Measured using scale completed by study team member removing wound dressing. Scores on the scale range from 1 to 5.
- Adherence of the dressing [ Time Frame: At time of dressing removal, up to 10 days post operative ]
- Skin breakdown [ Time Frame: At time of dressing removal, up to 10 days post operative ]Measured using the National Pressure Ulcer Advisory Panel Pressure Ulcer (NPUAP) States and Categories. Skin breakdown will be assigned a category/stage of I to IV.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781779
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Dhanunjaya Lakkireddy, MD||University of Kansas Medical Center|