Back to resultsA Comparison of Post-Sternotomy Dressings
Primary Purpose
Impaired Wound Healing, Postoperative Wound Infection-deep
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry Sterile Dressing
Metallic Silver Dressing
Ionic Silver Dressing
Sponsored by
About this trial
This is an interventional supportive care trial for Impaired Wound Healing focused on measuring Sternotomy incision, Silver dressing, Sternal wound infection
Eligibility Criteria
Inclusion Criteria:
- Adult (at least 21 years of age) inpatients awaiting cardiac surgery or outpatients seen in the pre-surgical testing area prior to admission for surgery
- Having surgery at the study setting
- English-speaking
- Able to understand and give consent
- Had the approval of their cardiothoracic surgeon to participate
- Had no known sensitivity to silver
- Had no known sensitivity to alginates
Exclusion Criteria:
- Known sensitivity to silver
- Known sensitivity to alginates
Sites / Locations
- Carilion Roanoke Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Active Comparator
Active Comparator
Arm Label
Dry Sterile Dressing
Metallic Silver Dressing
Ionic Silver Dressing
Arm Description
Subjects in this study arm received a dry sterile dressing (Primapore®, Smith & Nephew), a one-piece, peel-and-stick, non-transparent dressing. This dressing is the standard of care at the study facility for this population and was left in place for either 24 to 48 hours.
Subjects in this arm received a metallic silver dressing (Acticoat Post-Op®, Smith & Nephew), a one-piece, peel-and-stick and non-transparent dressing. This dressing is an absorbent postoperative dressing consisting of a nanocrystalline silver-coated polyurethane layer, a white polyurethane foam and an adhesive coated waterproof polyurethane film layer. Acticoat Post-Op may be left in place over a wound for up to 7 days. The manufacturers note that the product should not be used in patients with known silver allergies and that it may cause transient discoloration of the skin.
Subjects in this arm received an ionic silver dressing (Dermanet Ag®, DeRoyal), a semi-transparent dressing that includes silver, alginate, and maltodextrin. The dressing was cut to fit the incision and then covered with a transparent dressing (Transseal®, DeRoyal). This dressing should not be used on patients with known sensitivity to alginates (a seaweed based component).
Outcomes
Primary Outcome Measures
Wound Healing
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 dehisced (complete separation of layers). Skin integrity was evaluated as normal (pink, no redness), inflamed, (heat, redness, swelling), or macerated within a 2.5 centimeter border of the incision. Exudate quality was assessed as purulent, blood, serosanguinous, or serous. Presence or absence of necrotic tissue was noted.
Secondary Outcome Measures
Patient Comfort
The secondary outcome measure in this study was patient comfort with the dressing in place and upon removal. Comfort was measured using a 0-10 scale, with 0 signifying no pain and 10 signifying maximum pain.
Full Information
NCT ID
NCT02198066
First Posted
March 27, 2014
Last Updated
July 21, 2014
Sponsor
Carilion Clinic
Collaborators
DeRoyal Industries, Inc., Smith & Nephew, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02198066
Brief Title
A Comparison of Post-Sternotomy Dressings
Official Title
A Comparison of Post-Sternotomy Dressings
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carilion Clinic
Collaborators
DeRoyal Industries, Inc., Smith & Nephew, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
No other information included.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Wound Healing, Postoperative Wound Infection-deep
Keywords
Sternotomy incision, Silver dressing, Sternal wound infection
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
351 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry Sterile Dressing
Arm Type
Other
Arm Description
Subjects in this study arm received a dry sterile dressing (Primapore®, Smith & Nephew), a one-piece, peel-and-stick, non-transparent dressing. This dressing is the standard of care at the study facility for this population and was left in place for either 24 to 48 hours.
Arm Title
Metallic Silver Dressing
Arm Type
Active Comparator
Arm Description
Subjects in this arm received a metallic silver dressing (Acticoat Post-Op®, Smith & Nephew), a one-piece, peel-and-stick and non-transparent dressing. This dressing is an absorbent postoperative dressing consisting of a nanocrystalline silver-coated polyurethane layer, a white polyurethane foam and an adhesive coated waterproof polyurethane film layer. Acticoat Post-Op may be left in place over a wound for up to 7 days. The manufacturers note that the product should not be used in patients with known silver allergies and that it may cause transient discoloration of the skin.
Arm Title
Ionic Silver Dressing
Arm Type
Active Comparator
Arm Description
Subjects in this arm received an ionic silver dressing (Dermanet Ag®, DeRoyal), a semi-transparent dressing that includes silver, alginate, and maltodextrin. The dressing was cut to fit the incision and then covered with a transparent dressing (Transseal®, DeRoyal). This dressing should not be used on patients with known sensitivity to alginates (a seaweed based component).
Intervention Type
Other
Intervention Name(s)
Dry Sterile Dressing
Other Intervention Name(s)
Primapore (Smith & Nephew)
Intervention Description
Described in Arm Description.
Intervention Type
Other
Intervention Name(s)
Metallic Silver Dressing
Other Intervention Name(s)
Acticoat Post-Op (Smith & Nephew)
Intervention Description
Described in Arm Description.
Intervention Type
Other
Intervention Name(s)
Ionic Silver Dressing
Other Intervention Name(s)
Dermanet (DeRoyal)
Intervention Description
Described in Arm Description.
Primary Outcome Measure Information:
Title
Wound Healing
Description
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 dehisced (complete separation of layers). Skin integrity was evaluated as normal (pink, no redness), inflamed, (heat, redness, swelling), or macerated within a 2.5 centimeter border of the incision. Exudate quality was assessed as purulent, blood, serosanguinous, or serous. Presence or absence of necrotic tissue was noted.
Time Frame
5 days postoperatively or day of discharge, whichever came first
Secondary Outcome Measure Information:
Title
Patient Comfort
Description
The secondary outcome measure in this study was patient comfort with the dressing in place and upon removal. Comfort was measured using a 0-10 scale, with 0 signifying no pain and 10 signifying maximum pain.
Time Frame
5 days postoperatively or day of hospital discharge, whichever came first
Other Pre-specified Outcome Measures:
Title
Dressing Factors
Description
Dressing factors of ease of application, removal, and incision assessment were measured on a 5-point Likert-type scale (1=very easy, 2=moderately easy, 3=neither easy nor hard, 4=moderately hard, and 5=very hard). Dressing integrity was assessed as suture line exposed, poorly sealed (imperfect covering of the suture line with the potential for organism entry), or well-sealed.
Time Frame
5 days postoperatively or at day of discharge, whichever came first
Title
Sternal Wound Infection
Description
Investigators evaluated sternal wound infection presence and type (superficial or deep) using Centers for Disease Control/National Healthcare Safety Network surveillance definitions.
Time Frame
30 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (at least 21 years of age) inpatients awaiting cardiac surgery or outpatients seen in the pre-surgical testing area prior to admission for surgery
Having surgery at the study setting
English-speaking
Able to understand and give consent
Had the approval of their cardiothoracic surgeon to participate
Had no known sensitivity to silver
Had no known sensitivity to alginates
Exclusion Criteria:
Known sensitivity to silver
Known sensitivity to alginates
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy D. Jennings, DNP
Organizational Affiliation
Carilion Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carilion Roanoke Memorial Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Post-Sternotomy Dressings
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