Wound InfectionPhase 1NCT00576745
A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery
A Phase 1 study testing Vicryl Suture and 3M TM S Surgical Skin Closure System in people with Wound Infection, run by American Heart Association at 1 site in United States.
Trial summary
Following closure of surgical incisions, wounds may develop redness, swelling, and drainage which may result in increased pain and infection. This study will test to hypothesis that using the 3M TM S Surgical Skin Closure System will reduce the incidence of pain, redness, swelling, and infections in a group of… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Wound Infection
- What is being tested?
- Vicryl Suture and 3M TM S Surgical Skin Closure System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2010
- Phase
- Phase 1
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing mediastinotomy for cardiac surgical procedures
Who cannot join
- Patients with:
- Allergies to skin adhesives
- Known keloid formation
- Prior sternotomies
- Conditions making them not candidates for vicryl skin closure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of The 3M Surgical Skin Closure System To The Standard Vicryl Suture Closure Of Sternotomy Incisions
Following closure of surgical incisions, wounds may develop redness, swelling, and drainage which may result in increased pain and infection. This study will test to hypothesis that using the 3M TM S Surgical Skin Closure System will reduce the incidence of pain, redness, swelling, and infections in a group of patients undergoing a mediastinotomy incision used for open heart surgical procedures.
- Conditions
- Wound Infection
- Being tested
- Vicryl Suture, 3M TM S Surgical Skin Closure System
- Keywords
- Sutures
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vicryl SutureProcedure or surgery
A 4-0 vicryl suture will be used to close the subcuticular layer
3M TM S Surgical Skin Closure SystemDevice
These steri-strips will be applied to close the skin in this cohort of patients
| Study group | Role | What they receive |
|---|---|---|
| 1 Vicryl Suture | Active comparator | Patients will have their incision closed with vicryl suture Receives: Procedure: Vicryl Suture |
| 2 Steri-Strips | Experimental | Patients will have their incisions closed with 3M Surgical-Strips Receives: Device: 3M TM S Surgical Skin Closure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of erythema
Measured: 30 days following surgery
Secondary outcomes (1)
Incidence of infection
Measured: 30 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Heart Association
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harold L. Lazar MD, Boston Medical Center
- Investigators
- Harold L Lazar MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576745
- Sponsor's protocol ID
- H-26298
- Status last verified
- Jul 2012
- First submitted
- 18 Dec 2007
- Last updated
- 18 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lazar HL, McCann J, Fitzgerald CA, Cabral HJ. Adhesive strips versus subcuticular suture for mediansternotomy wound closure. J Card Surg. 2011 Jul;26(4):344-7. doi: 10.1111/j.1540-8191.2011.01257.x. Epub 2011 May 9.
PubMed 21554389
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The 3M Surgical Skin Closure System To The Standard Vicryl Suture Closure Of Sternotomy Incisions
- ClinicalTrials.gov ID
- NCT00576745
- Acronym / sponsor ID
- H-26298
- Conditions
- Wound Infection
- Keywords
- Sutures
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- American Heart AssociationUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Dec 2007 (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.
Following closure of surgical incisions, wounds may develop redness, swelling, and drainage which may result in increased pain and infection. This study will test to hypothesis that using the 3M TM S Surgical Skin Closure System will reduce the incidence of pain, redness, swelling, and infections in a group of patients undergoing a mediastinotomy incision used for open heart surgical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Vicryl Suture | Active comparator | Procedure: Vicryl SuturePatients will have their incision closed with vicryl suture |
| 2 Steri-Strips | Experimental | Device: 3M TM S Surgical Skin Closure SystemPatients will have their incisions closed with 3M Surgical-Strips |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing mediastinotomy for cardiac surgical procedures
Key exclusion criteria (5 listed)
- Allergies to skin adhesives
- Known keloid formation
- Prior sternotomies
- Conditions making them not candidates for vicryl skin closure
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 |
|---|---|---|
| Vicryl SutureA 4-0 vicryl suture will be used to close the subcuticular layer | Procedure or surgery | 1 Vicryl Suture |
| 3M TM S Surgical Skin Closure SystemThese steri-strips will be applied to close the skin in this cohort of patients | Device | 2 Steri-Strips |
Primary outcome
Incidence of erythema
Time frame: 30 days following surgery
1 secondary outcome
Incidence of infection
Time frame: 30 days following surgery
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 18 Jul 2012.
- Results publication: PubMed 21554389Lazar HL, McCann J, Fitzgerald CA, Cabral HJ. Adhesive strips versus subcuticular suture for mediansternotomy wound closure. J Card Surg. 2011 Jul;26(4):344-7. doi: 10.1111/j.1540-8191.2011.01257.x. Epub 2011 May 9.
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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.
Harold L Lazar MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vicryl Suture and 3M TM S Surgical Skin Closure System in people with Wound Infection, run by American Heart Association 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 1 inclusion and 5 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 18 Jul 2012. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incidence of erythema (time frame: 30 days following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00576745, which also lists 1 linked publication.
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 18 Jul 2012.