Trial Outcomes & Findings for Study Looking at the Effect of Silverlon on Post Operative Wound Infections (NCT NCT01143883)

Last Updated: 2013-06-13

Results Overview

We will monitor the incision from the day of surgery to post operative day 30 to determine if the incision needs antibiotics.

Recruitment status

COMPLETED

Study phase

Target enrollment

110 participants

Primary outcome timeframe

Day of surgery up to 30 days post operatively

Results posted on

2013-06-13

Participant Flow

All 110 patients were consented for this study during their pre-operative visit.

Participant milestones

Participant milestones
Measure	Silverlon Dressing The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon.	Standard of Care Dressing The standard plain gauze is used to dress the wound postoperatively
Overall Study STARTED	55	55
Overall Study COMPLETED	55	55
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Looking at the Effect of Silverlon on Post Operative Wound Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Silverlon Dressing n=55 Participants 55	Standard of Care Dressing n=55 Participants 55	Total n=110 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	45 Participants n=99 Participants	4 Participants n=107 Participants	49 Participants n=206 Participants
Age, Categorical >=65 years	10 Participants n=99 Participants	48 Participants n=107 Participants	58 Participants n=206 Participants
Age Continuous	62 years STANDARD_DEVIATION 15.6 • n=99 Participants	58 years STANDARD_DEVIATION 11.1 • n=107 Participants	60 years STANDARD_DEVIATION 13.7 • n=206 Participants
Gender Female	27 participants n=99 Participants	28 participants n=107 Participants	55 participants n=206 Participants
Gender Male	28 participants n=99 Participants	26 participants n=107 Participants	54 participants n=206 Participants
Region of Enrollment United States	55 participants n=99 Participants	55 participants n=107 Participants	110 participants n=206 Participants

PRIMARY outcome

Timeframe: Day of surgery up to 30 days post operatively

Population: The number of participants analyzed was based on the number who received treatment according to their randomized group and were treated according to study protocol

We will monitor the incision from the day of surgery to post operative day 30 to determine if the incision needs antibiotics.

Outcome measures

Outcome measures
Measure	Silverlon Dressing n=55 Participants 55	Standard of Care Dressing n=54 Participants 55
Surgical Site Infection	13 percentage of participants with SSI	33 percentage of participants with SSI

Adverse Events

Silverlon Dressing

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Standard of Care Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Silverlon Dressing n=55 participants at risk 55	Standard of Care Dressing n=55 participants at risk 55
Skin and subcutaneous tissue disorders Rash	1.8% 1/55	0.00% 0/55

Additional Information

Jorge E. Marcet, M.D.

University of South Florida

Phone: 813-844-4545

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place