A Comparison of Post-Sternotomy Dressings

Impaired Wound Healing Clinical Trial

Official title:

A Comparison of Post-Sternotomy Dressings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198066
• Other study ID #: CC-2014-1
• Status: Completed
• Phase: N/A
• First received: March 27, 2014
• Last updated: July 21, 2014
• Start date: July 2010
• Est. completion date: August 2012

Study information

• Verified date: March 2014
• Source: Carilion Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

No other information included.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Impaired Wound Healing
• Postoperative Wound Infection-deep
• Surgical Wound Infection
• Wound Infection

Intervention

Other:
• Dry Sterile Dressing
Described in Arm Description.
• Metallic Silver Dressing
Described in Arm Description.
• Ionic Silver Dressing
Described in Arm Description.

Locations

Country	Name	City	State
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Carilion Clinic	DeRoyal Industries, Inc., Smith & Nephew, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Dressing Factors	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.	5 days postoperatively or at day of discharge, whichever came first	No
Other	Sternal Wound Infection	Investigators evaluated sternal wound infection presence and type (superficial or deep) using Centers for Disease Control/National Healthcare Safety Network surveillance definitions.	30 days postoperatively	No
Primary	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.	5 days postoperatively or day of discharge, whichever came first	No
Secondary	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.	5 days postoperatively or day of hospital discharge, whichever came first	No