Impaired Wound HealingNCT02198066
A Comparison of Post-Sternotomy Dressings
A study testing Dry Sterile Dressing, Metallic Silver Dressing and Ionic Silver Dressing in people with Impaired Wound Healing and Postoperative Wound Infection-deep, run by Carilion Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Impaired Wound Healing, Postoperative Wound Infection-deep
- What is being tested?
- Dry Sterile Dressing, Metallic Silver Dressing and Ionic Silver Dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known sensitivity to silver
- Known sensitivity to alginates
Trial locations and contacts
1 site in 1 country.
United States1 site
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
About this study
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.
Read the detailed description
No other information included.
- Being tested
- Dry Sterile Dressing, Metallic Silver Dressing, Ionic Silver Dressing
- Keywords
- Sternotomy incision, Silver dressing, Sternal wound infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Sterile DressingOther
Also called Primapore (Smith & Nephew)
Described in Arm Description.
Metallic Silver DressingOther
Also called Acticoat Post-Op (Smith & Nephew)
Described in Arm Description.
Ionic Silver DressingOther
Also called Dermanet (DeRoyal)
Described in Arm Description.
| Study group | Role | What they receive |
|---|---|---|
| Dry Sterile Dressing | Other | 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. Receives: Other: Dry Sterile Dressing |
| Metallic Silver Dressing | Active comparator | 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. Receives: Other: Metallic Silver Dressing |
| Ionic Silver Dressing | Active comparator | 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). Receives: Other: Ionic Silver Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 days postoperatively or day of discharge, whichever came first
Secondary outcomes (1)
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.
Measured: 5 days postoperatively or day of hospital discharge, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startJul 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- DeRoyal Industries, Inc., Smith & Nephew, Inc.
- Responsible party
- Sponsor
- Investigators
- Cathy D. Jennings, DNP, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198066
- Sponsor's protocol ID
- CC-2014-1
- Status last verified
- Mar 2014
- First submitted
- 27 Mar 2014
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Post-Sternotomy Dressings
- ClinicalTrials.gov ID
- NCT02198066
- Acronym / sponsor ID
- CC-2014-1
- Keywords
- Sternotomy incision, Silver dressing, Sternal wound infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- DeRoyal Industries, Inc., Smith & Nephew, Inc.
- Study start
- Jul 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dry Sterile Dressing | Other | Other: Dry Sterile DressingSubjects 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. |
| Metallic Silver Dressing | Active comparator | Other: Metallic Silver DressingSubjects 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. |
| Ionic Silver Dressing | Active comparator | Other: Ionic Silver DressingSubjects 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). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Known sensitivity to silver
- Known sensitivity to alginates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry Sterile DressingAlso: Primapore (Smith & Nephew)Described in Arm Description. | Other | Dry Sterile Dressing |
| Metallic Silver DressingAlso: Acticoat Post-Op (Smith & Nephew)Described in Arm Description. | Other | Metallic Silver Dressing |
| Ionic Silver DressingAlso: Dermanet (DeRoyal)Described in Arm Description. | Other | Ionic Silver Dressing |
Primary outcome
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 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.
1 secondary outcome
Patient Comfort
Time frame: 5 days postoperatively or day of hospital discharge, whichever came first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy D. Jennings, DNP principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Sterile Dressing, Metallic Silver Dressing and Ionic Silver Dressing in people with Impaired Wound Healing and Postoperative Wound Infection-deep, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing (time frame: 5 days postoperatively or day of discharge, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.