Trial Outcomes & Findings for Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant (NCT NCT02781779)

Last Updated: 2023-03-10

Results Overview

A pocket hematoma is an accumulation of blood in or near the surgical incision which occurs because of a defect in hemostasis such as injury to blood vessels. Pocket hematoma is associated with local discomfort, an increased risk of infection, and may require surgical intervention or lead to lengthier hospital stays. Mild - Ecchymosis or mild effusion in the pocket, no swelling or pain to device-pocket (watchful waiting) Moderate - Large effusion in the pocket leading to swelling and causing functional impairment or pain to device-pocket Severe - Any pocket hematoma requiring: Reoperation and/or resulting in prolongation of hospitalization (defined as extended hospitalization or rehospitalization for \>24 hours, postindex surgery, primarily due to hematoma) and/or requiring interruption of OAC (defined as reversal or intentional withholding, in response to pocket hematoma, resulting in subtherapeutic anticoagulation for \>24 hours)

Recruitment status

COMPLETED

Study phase

Target enrollment

147 participants

Primary outcome timeframe

7-10 days post implant

Results posted on

2023-03-10

Participant Flow

Prospectively enrolled patients undergoing CIED implantation, upgrade, or generator change from June 2016-June 2017 were randomized to receive one of the two dressings at the end of the procedure.

Immunocompromised patients and those on non-standard antibiotic regimens were excluded.

Participant milestones

Participant milestones
Measure	Silverlon® Subjects randomized to this arm will receive Silverlon® dressing postoperative. Silverlon®: Silverlon wound dressings	AQUACEL® AG Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative. AQUACEL® AG: AQUACEL® AG wound dressings
Overall Study STARTED	78	69
Overall Study COMPLETED	78	69
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Silverlon® n=78 Participants Subjects randomized to this arm will receive Silverlon® dressing postoperative. Silverlon®: Silverlon wound dressings	AQUACEL® AG n=69 Participants Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative. AQUACEL® AG: AQUACEL® AG wound dressings	Total n=147 Participants Total of all reporting groups
Age, Continuous	70.4 Years STANDARD_DEVIATION 13.7 • n=5 Participants	68.5 Years STANDARD_DEVIATION 14.2 • n=7 Participants	69 Years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	47 Participants n=7 Participants	101 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	76 Participants n=5 Participants	68 Participants n=7 Participants	144 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	78 participants n=5 Participants	69 participants n=7 Participants	147 participants n=5 Participants
body mass index (BMI)	29.7 kg/m^2 STANDARD_DEVIATION 6.3 • n=5 Participants	29.9 kg/m^2 STANDARD_DEVIATION 5.7 • n=7 Participants	29.79 kg/m^2 STANDARD_DEVIATION 6.06 • n=5 Participants
Diabetes	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Chronic Kidney Disease (CKD)	20 Participants n=5 Participants	15 Participants n=7 Participants	35 Participants n=5 Participants
Oral Anticoagulant (OAC)	33 Participants n=5 Participants	32 Participants n=7 Participants	65 Participants n=5 Participants
Platelets	210 Platelets*1000 STANDARD_DEVIATION 72 • n=5 Participants	213 Platelets*1000 STANDARD_DEVIATION 65 • n=7 Participants	211.41 Platelets*1000 STANDARD_DEVIATION 68.59 • n=5 Participants
Serum Creatinine (Serum Cr)	1.15 mg/dL STANDARD_DEVIATION 0.46 • n=5 Participants	1.17 mg/dL STANDARD_DEVIATION 0.45 • n=7 Participants	1.16 mg/dL STANDARD_DEVIATION 0.45 • n=5 Participants
International Normalized Ratio (INR)	2 Ratio STANDARD_DEVIATION 1 • n=5 Participants	2 Ratio STANDARD_DEVIATION 1 • n=7 Participants	2 Ratio STANDARD_DEVIATION 0.997 • n=5 Participants

PRIMARY outcome

Timeframe: 7-10 days post implant