Postoperative Wound InfectionPhase 4NCT01212315
Effects of Triclosan-coated Sutures in Cardiac Surgery
A Phase 4 study testing Triclosan coated sutures in people with Postoperative Wound Infection, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to assess if triclosan-coated sutures reduces wound infections after saphenous vein harvesting in CABG patients. Secondary objectives are the effect triclosan-coated sutures on sternal wound infections and a cost analysis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Wound Infection
- What is being tested?
- Triclosan coated sutures
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2009to Jun 2012
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective CABG at Sahlgrenska University Hospital with intended use of saphenous vein graft are included.
Who cannot join
- Patients with on-going sepsis or septicaemia, bacterial infections or known allergy to triclosan are excluded.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital
Gothenburg, 413 45
About this study
Official title: Triclosan-coated Sutures in Cardiac Surgery:Effects on Leg Wound Infections and Costs
The purpose of this study is to assess if triclosan-coated sutures reduces wound infections after saphenous vein harvesting in CABG patients. Secondary objectives are the effect triclosan-coated sutures on sternal wound infections and a cost analysis.
Read the detailed description
The role of the suture material for the development of postoperative wound infection has been debated for many years. It has been reported that fewer bacteria adhere to monofilament polypropylene than braided polyester sutures in vitro but the results are opposed by a non-randomized clinical study where the use of monofilament sutures was identified as an independent risk factor for leg wound infections after CABG.
- Conditions
- Postoperative Wound Infection
- Being tested
- Triclosan coated sutures
- Keywords
- Wound infection, SSI, Suture
- Medical subject headings
- Surgical Wound Infection, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triclosan coated suturesDevice
Also called Monocryl Plus suture, Vicryl Plus suture
Subcutaneous and cutaneous sutures coated with triclosan (Vicryl Plus / Monocryl Plus) are used to close the incisions after vein harvesting and sternotomy. All wounds are inspected before discharge from hospital and the patients are instructed to contact the study coordinator if any suspected infection occurs. In addition, all patients are controlled after thirty days by a nurse and contacted by telephone sixty days after surgery to assess postoperative infections by a predefined questionnaire. Infection symptoms are graded according to the Asepsis score and the CDC classification. Patient records including bacterial cultures and antibiotic treatment are collected for all patients with suspected infections.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Ordinary sutures (Vicryl / Monocryl) is used for wound closure |
| Group A | Active comparator | Triclosan coated sutures (Vicryl Plus / Monocryl Plus) is used for wound closure Receives: Device: Triclosan coated sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with leg wound infection.
Primary endpoint is postoperative leg wound infection within 60 days after surgery according to the definition of Center for Disease Control.
Measured: Within 60 days after heartsurgery
Secondary outcomes (1)
Culture-proven and antibiotic-treated wound infection after heart surgery
Measured: Within 60 days after heart surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startMar 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Wound InfectionStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Jeppssons, Sahlgrenska University Hospital
- Investigators
- Anders Jeppsson, MD PhD, Principal investigator, Sahlgrenska Univerity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212315
- Sponsor's protocol ID
- 001
- Status last verified
- Dec 2012
- First submitted
- 29 Sep 2010
- Last updated
- 20 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Steingrimsson S, Thimour-Bergstrom L, Roman-Emanuel C, Schersten H, Friberg O, Gudbjartsson T, Jeppsson A. Triclosan-coated sutures and sternal wound infections: a prospective randomized clinical trial. Eur J Clin Microbiol Infect Dis. 2015 Dec;34(12):2331-8. doi: 10.1007/s10096-015-2485-8. Epub 2015 Oct 2.
PubMed 26432552Thimour-Bergstrom L, Roman-Emanuel C, Schersten H, Friberg O, Gudbjartsson T, Jeppsson A. Triclosan-coated sutures reduce surgical site infection after open vein harvesting in coronary artery bypass grafting patients: a randomized controlled trial. Eur J Cardiothorac Surg. 2013 Nov;44(5):931-8. doi: 10.1093/ejcts/ezt063. Epub 2013 Feb 22.
PubMed 23435526
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triclosan-coated Sutures in Cardiac Surgery:Effects on Leg Wound Infections and Costs
- ClinicalTrials.gov ID
- NCT01212315
- Acronym / sponsor ID
- 001
- Conditions
- Postoperative Wound Infection
- Keywords
- Wound infection, SSI, Suture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Sep 2010 (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 is to assess if triclosan-coated sutures reduces wound infections after saphenous vein harvesting in CABG patients. Secondary objectives are the effect triclosan-coated sutures on sternal wound infections and a cost analysis.
Detailed description
The role of the suture material for the development of postoperative wound infection has been debated for many years. It has been reported that fewer bacteria adhere to monofilament polypropylene than braided polyester sutures in vitro but the results are opposed by a non-randomized clinical study where the use of monofilament sutures was identified as an independent risk factor for leg wound infections after CABG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Ordinary sutures (Vicryl / Monocryl) is used for wound closure |
| Group A | Active comparator | Device: Triclosan coated suturesTriclosan coated sutures (Vicryl Plus / Monocryl Plus) is used for wound closure |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective CABG at Sahlgrenska University Hospital with intended use of saphenous vein graft are included.
Key exclusion criteria (1 listed)
- Patients with on-going sepsis or septicaemia, bacterial infections or known allergy to triclosan are excluded.
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 |
|---|---|---|
| Triclosan coated suturesAlso: Monocryl Plus suture, Vicryl Plus sutureSubcutaneous and cutaneous sutures coated with triclosan (Vicryl Plus / Monocryl Plus) are used to close the incisions after vein harvesting and sternotomy. All wounds are inspected before discharge from hospital and the patients are instructed to contact the study coordinator if any suspected infection occurs. In addition, all patients are controlled after thirty days by a nurse and contacted by telephone sixty days after surgery to assess postoperative infections by a predefined questionnaire. Infection symptoms are graded according to the Asepsis score and the CDC classification. Patient records including bacterial cultures and antibiotic treatment are collected for all patients with suspected infections. | Device | Group A |
Primary outcome
Proportion of subjects with leg wound infection.
Time frame: Within 60 days after heartsurgery
Primary endpoint is postoperative leg wound infection within 60 days after surgery according to the definition of Center for Disease Control.
1 secondary outcome
Culture-proven and antibiotic-treated wound infection after heart surgery
Time frame: Within 60 days after heart 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 20 Dec 2012.
- Derived from this study: PubMed 26432552Steingrimsson S, Thimour-Bergstrom L, Roman-Emanuel C, Schersten H, Friberg O, Gudbjartsson T, Jeppsson A. Triclosan-coated sutures and sternal wound infections: a prospective randomized clinical trial. Eur J Clin Microbiol Infect Dis. 2015 Dec;34(12):2331-8. doi: 10.1007/s10096-015-2485-8. Epub 2015 Oct 2.
- Derived from this study: PubMed 23435526Thimour-Bergstrom L, Roman-Emanuel C, Schersten H, Friberg O, Gudbjartsson T, Jeppsson A. Triclosan-coated sutures reduce surgical site infection after open vein harvesting in coronary artery bypass grafting patients: a randomized controlled trial. Eur J Cardiothorac Surg. 2013 Nov;44(5):931-8. doi: 10.1093/ejcts/ezt063. Epub 2013 Feb 22.
Related trials for Postoperative Wound Infection
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
RecruitingObservational study
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Surgical Site Infection
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Not yet recruitingPhase 3
Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:
Next Generation Sequencing (NGS), Surgical Site Infection (SSI)
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.
Anders Jeppsson, MD PhD principal investigator
Sahlgrenska Univerity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triclosan coated sutures in people with Postoperative Wound Infection, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 1 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 20 Dec 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 Sweden. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of subjects with leg wound infection. (time frame: Within 60 days after heartsurgery). 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 NCT01212315, which also lists 2 linked publications.
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 20 Dec 2012.