Surgical Site InfectionPhase 3NCT03763279
Effect of Barbed Suture and Triclosan-coated Monofilament in Emergency Surgery
A Phase 3 study testing Triclosan-coated barbed suture, Triclosan-coated monofilament suture and Monofilament suture in people with Surgical Site Infection, run by Hospital General Universitario Elche at 1 site in Spain.
Trial summary
Patients will be randomized 3 groups: Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture Group 2:Abdominal fascial closure will be performed with Triclosan-coated monofilament Polydioxanone suture Group 3: Abdominal fascial closure will be performed with monofilament… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Triclosan-coated barbed suture, Triclosan-coated monofilament suture and Monofilament suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2018to 31 Mar 2019
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Contaminated and Dirty surgery
- Emergency surgery performed by midline laparotomic approach
- The following diagnosis will be included:
- Anastomotic leak of previous digestive surgery (colon, small bowel or gastric surgery)
- Colonic or bowel perforations
- Appendicitis with purulent of fecal peritonitis, undergoing midline laparotomy
- Perforation of gastric or duodenal ulcer
- Intestinal ischemia requiring bowel resection
Who cannot join
- Emergency surgery undergoing laparoscopic approach
- Appendicitis operated by McBurney incision
- Intestinal isquemia without requiring bowel resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Suture of the Abdominal Wall With Triclosan-coated Polydioxanone Barbed Suture vs Triclosan-coated Polydioxanone Monofilament vs Polydioxanone Monofilament in Emergency Surgery
Patients will be randomized 3 groups:
Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture
Group 2:Abdominal fascial closure will be performed with Triclosan-coated monofilament Polydioxanone suture
Group 3: Abdominal fascial closure will be performed with monofilament Polydioxanone suture
Incisional surgical.site infection and evisceration will be recorded.
Read the detailed description
Patients will be randomized 3 groups:
Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture (Stratafix Symmetric, J\&J), caliber 1, 48mm-cylindric needle.
Group 2:Abdominal fascial closure will be performed with Triclosan-coated Polydioxanone loop suture (PDS plus looc, J\&J), caliber 1, 48mm-cylindric needle.
Group 3: Abdominal fascial closure will be performed with Polydioxanone loop suture (PDS plus looc, J\&J), caliber 1, 48mm-cylindric needle.
Incisional surgical.site infection and evisceration will be recorded.
- Conditions
- Surgical Site Infection
- Being tested
- Triclosan-coated barbed suture, Triclosan-coated monofilament suture, Monofilament suture
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triclosan-coated barbed sutureCombination product
Use of Triclosan-coated Polydioxanone barbed suture
Triclosan-coated monofilament sutureCombination product
Use of Triclosan-coated Polydioxanone monofilament suture
Monofilament sutureDevice
Use of Polydioxanone monofilament suture
| Study group | Role | What they receive |
|---|---|---|
| Triclosan-coated barbed suture | Experimental | Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone barbed suture Receives: Combination Product: Triclosan-coated barbed suture |
| Triclosan-coated monofilament suture | Experimental | Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone monofilament suture Receives: Combination Product: Triclosan-coated monofilament suture |
| Monofilament suture | Sham comparator | Abdominal wall closure will be performed using a monofilament suture Receives: Device: Monofilament suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of incisional surgical-site infection
Diagnosis of incisional surgical-site infection during the postoperative course
Measured: 30 days postoperatively
Secondary outcomes (1)
Rate of Evisceration
Diagnosis of evisceration during the postoperative course, which will be assessed by physical examination
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start30 Nov 2018
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
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 Surgical Site 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Andres Garcia-Marin, Study director, Hospital de San Juan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03763279
- Sponsor's protocol ID
- HRJC-HUSJ 18-10
- Status last verified
- Sep 2019
- First submitted
- 30 Nov 2018
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruiz-Tovar J, Llavero C, Jimenez-Fuertes M, Duran M, Perez-Lopez M, Garcia-Marin A. Incisional Surgical Site Infection after Abdominal Fascial Closure with Triclosan-Coated Barbed Suture vs Triclosan-Coated Polydioxanone Loop Suture vs Polydioxanone Loop Suture in Emergent Abdominal Surgery: A Randomized Clinical Trial. J Am Coll Surg. 2020 May;230(5):766-774. doi: 10.1016/j.jamcollsurg.2020.02.031. Epub 2020 Feb 27.
PubMed 32113031
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suture of the Abdominal Wall With Triclosan-coated Polydioxanone Barbed Suture vs Triclosan-coated Polydioxanone Monofilament vs Polydioxanone Monofilament in Emergency Surgery
- ClinicalTrials.gov ID
- NCT03763279
- Acronym / sponsor ID
- HRJC-HUSJ 18-10
- Conditions
- Surgical Site Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 4 Dec 2018 (actual)
- 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.
Patients will be randomized 3 groups:
Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture
Group 2:Abdominal fascial closure will be performed with Triclosan-coated monofilament Polydioxanone suture
Group 3: Abdominal fascial closure will be performed with monofilament Polydioxanone suture
Incisional surgical.site infection and evisceration will be recorded.
Detailed description
Patients will be randomized 3 groups:
Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed Polydioxanone suture (Stratafix Symmetric, J\&J), caliber 1, 48mm-cylindric needle.
Group 2:Abdominal fascial closure will be performed with Triclosan-coated Polydioxanone loop suture (PDS plus looc, J\&J), caliber 1, 48mm-cylindric needle.
Group 3: Abdominal fascial closure will be performed with Polydioxanone loop suture (PDS plus looc, J\&J), caliber 1, 48mm-cylindric needle.
Incisional surgical.site infection and evisceration will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triclosan-coated barbed suture | Experimental | Combination Product: Triclosan-coated barbed sutureAbdominal wall closure will be performed using a Triclosan-coated Polydioxanone barbed suture |
| Triclosan-coated monofilament suture | Experimental | Combination Product: Triclosan-coated monofilament sutureAbdominal wall closure will be performed using a Triclosan-coated Polydioxanone monofilament suture |
| Monofilament suture | Sham comparator | Device: Monofilament sutureAbdominal wall closure will be performed using a monofilament suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Contaminated and Dirty surgery
- Emergency surgery performed by midline laparotomic approach
- The following diagnosis will be included:
Key exclusion criteria (3 listed)
- Emergency surgery undergoing laparoscopic approach
- Appendicitis operated by McBurney incision
- Intestinal isquemia without requiring bowel resection
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 barbed sutureUse of Triclosan-coated Polydioxanone barbed suture | Combination product | Triclosan-coated barbed suture |
| Triclosan-coated monofilament sutureUse of Triclosan-coated Polydioxanone monofilament suture | Combination product | Triclosan-coated monofilament suture |
| Monofilament sutureUse of Polydioxanone monofilament suture | Device | Monofilament suture |
Primary outcome
Rate of incisional surgical-site infection
Time frame: 30 days postoperatively
Diagnosis of incisional surgical-site infection during the postoperative course
1 secondary outcome
Rate of Evisceration
Time frame: 30 days postoperatively
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 16 Sep 2019.
- Derived from this study: PubMed 32113031Ruiz-Tovar J, Llavero C, Jimenez-Fuertes M, Duran M, Perez-Lopez M, Garcia-Marin A. Incisional Surgical Site Infection after Abdominal Fascial Closure with Triclosan-Coated Barbed Suture vs Triclosan-Coated Polydioxanone Loop Suture vs Polydioxanone Loop Suture in Emergent Abdominal Surgery: A Randomized Clinical Trial. J Am Coll Surg. 2020 May;230(5):766-774. doi: 10.1016/j.jamcollsurg.2020.02.031. Epub 2020 Feb 27.
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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.
Andres Garcia-Marin study director
Hospital de San Juan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triclosan-coated barbed suture, Triclosan-coated monofilament suture and Monofilament suture in people with Surgical Site Infection, run by Hospital General Universitario Elche at 1 site in Spain.
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 8 inclusion and 3 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 16 Sep 2019. 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 Spain. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Rate of incisional surgical-site infection (time frame: 30 days postoperatively). 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 NCT03763279, 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 16 Sep 2019.