NCT02198066

A Comparison of Post-Sternotomy Dressings

Completed NA Last updated 21 July 2014

What this trial tests

NA trial testing Dry Sterile Dressing in Impaired Wound Healing in 351 participants. Completed in 1 August 2012.

Timeline

1 July 2010

Primary endpoint
1 August 2012

1 August 2012

Quick facts

Lead sponsor	Carilion Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	351
Start date	1 July 2010
Primary completion	1 August 2012
Estimated completion	1 August 2012
Sites	1 location across United States

Drugs / interventions tested

• Dry Sterile Dressing
• Metallic Silver Dressing
• Ionic Silver Dressing

Conditions studied

• Impaired Wound Healing — all drugs for Impaired Wound Healing →
• Postoperative Wound Infection-deep — all drugs for Postoperative Wound Infection-deep →

Sponsor

Carilion Clinic

Who can join

21 and older, any sex, with Impaired Wound Healing or Postoperative Wound Infection-deep. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Wound Healing
  Time frame: 5 days postoperatively or day of discharge, whichever came first
  The primary outcome measure in this study was wound healing, defined as the degree of wound approximation, skin integrity, exudate, and presence/absence of necrotic tissue, assessed at postoperative day 5 or day of discharge. Wound approximation was assessed as total, partial (less than 2 centimeters of superficial separation), moderate (greater than 2 centimeters of superficial separation), or de

Sponsor's own description

The purpose of this study was to determine which of three types of dressings, a dry sterile dressing, a metallic silver dressing or an ionic silver dressing provided better patient outcomes for the post-sternotomy cardiac surgery patient population. In this prospective, randomized controlled trial, the hypothesis was that subjects who received either of the silver impregnated dressings would have better outcomes (better wound healing, less discomfort, and less incidence of infection). Investigators also evaluated dressing factors such as adherence, time for application and ease of use.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Borrowing the Features of Biopolymers for Emerging Wound Healing Dressings: A Review.
   Gardikiotis I, Cojocaru FD, Mihai CT, Balan V, et al · · 2022 · cited 33× · PMID 35955912 · DOI 10.3390/ijms23158778