Surgical Site InfectionNCT03408782
Drains and Surgical Site Infections
An observational study of Surgical Site Infection, run by University Hospital, Basel, Switzerland.
Trial summary
This prospective observational study examines the associations of presence, duration, type, number and location of surgical drains with the risk of surgical site infections in a contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery procedures. 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?
- Insertion of drainage
- Type of treatment
- Surgery or procedure
- How many people
- 4,584 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2013to 31 Aug 2015
- Phase
- Observational
- 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
Study population: This observational study is nested in a multicenter randomized controlled trial that was designed to evaluate the optimal timing of surgical antimicrobial prophylaxis in a general, orthopedic trauma and vascular surgery population. The term "general surgery" refers to gastrointestinal, oncologic breast, endocrine and hernia surgery. The study centers are two tertiarry referral hospitals in Switzerland. All patients included in the randomized controlled trial are included in this observational study as well.
Who may be able to join
- Inpatients
- Age 18 years or older
- General, orthopedic trauma and vascular procedures
- Surgical antimicrobial prophylaxis
Who cannot join
- outpatient surgery
- Presence of a contraindication for cefuroxime and/or metronidazole
- preexisting antibiotic therapy within 14 days prior to surgery
- cognitive impairment
- combined operations including other than the above specified surgical divisions
- Emergency procedures with planned incision within 2 hours after indicating the procedure.
About this study
Official title: The Association of Surgical Drains With the Risk of Surgical Site Infection - a Prospective Observational Study
This prospective observational study examines the associations of presence, duration, type, number and location of surgical drains with the risk of surgical site infections in a contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery procedures.
Read the detailed description
Surgical site infections (SSI) represent the most common type of nosocomial infection amongst surgical patients. They cause morbidity and mortality.
Surgical Drains are commonly inserted at the end of many surgical procedures. In contrast to potential benefits, drains are also thought to potentially serve as a conduit of bacteria into the wound and hence may increase the risk of SSI. Patterns of use of drains vary widely across surgical disciplines and individual practices. There are no uniform guidelines and standards are often rather based on tradition than on evidence. The aim of this large prospective study was to examine the association of presence, duration, type, number and location of drains with the risk of SSI in a contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery procedures.
- Conditions
- Surgical Site Infection
- Being tested
- Insertion of drainage
- Keywords
- Surgical Site Infection, Surgical drains
- 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.
Insertion of drainageProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| No drainage | Those patients that underwent surgery and no drain was inserted at the end of the procedure | |
| Drainage | Those patients that underwent surgery and one or several drains were inserted at the end of the procedure. Receives: Procedure: Insertion of drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
The occurrence of surgical site infection according to CDC criteria
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start22 Feb 2013
- Primary completion31 Aug 2015
- Study completion31 Aug 2015
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,584 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edin Mujagic, University Hospital, Basel, Switzerland
- Investigators
- Edin Mujagic, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408782
- Sponsor's protocol ID
- ch10Weber
- Status last verified
- Jan 2018
- First submitted
- 17 Jan 2018
- Last updated
- 24 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Weber WP, Mujagic E, Zwahlen M, Bundi M, Hoffmann H, Soysal SD, Kraljevic M, Delko T, von Strauss M, Iselin L, Da Silva RXS, Zeindler J, Rosenthal R, Misteli H, Kindler C, Muller P, Saccilotto R, Lugli AK, Kaufmann M, Gurke L, von Holzen U, Oertli D, Bucheli-Laffer E, Landin J, Widmer AF, Fux CA, Marti WR. Timing of surgical antimicrobial prophylaxis: a phase 3 randomised controlled trial. Lancet Infect Dis. 2017 Jun;17(6):605-614. doi: 10.1016/S1473-3099(17)30176-7. Epub 2017 Apr 3.
PubMed 28385346Mujagic E, Zwimpfer T, Marti WR, Zwahlen M, Hoffmann H, Kindler C, Fux C, Misteli H, Iselin L, Lugli AK, Nebiker CA, von Holzen U, Vinzens F, von Strauss M, Reck S, Kraljevic M, Widmer AF, Oertli D, Rosenthal R, Weber WP. Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial. Trials. 2014 May 24;15:188. doi: 10.1186/1745-6215-15-188.
PubMed 24885132
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Surgical Drains With the Risk of Surgical Site Infection - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03408782
- Acronym / sponsor ID
- ch10Weber
- Conditions
- Surgical Site Infection
- Keywords
- Surgical Site Infection, Surgical drains
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,584 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 22 Feb 2013 (actual)
- Primary completion
- 31 Aug 2015 (actual)
- Study completion
- 31 Aug 2015 (actual)
- First posted
- 24 Jan 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.
This prospective observational study examines the associations of presence, duration, type, number and location of surgical drains with the risk of surgical site infections in a contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery procedures.
Detailed description
Surgical site infections (SSI) represent the most common type of nosocomial infection amongst surgical patients. They cause morbidity and mortality.
Surgical Drains are commonly inserted at the end of many surgical procedures. In contrast to potential benefits, drains are also thought to potentially serve as a conduit of bacteria into the wound and hence may increase the risk of SSI. Patterns of use of drains vary widely across surgical disciplines and individual practices. There are no uniform guidelines and standards are often rather based on tradition than on evidence. The aim of this large prospective study was to examine the association of presence, duration, type, number and location of drains with the risk of SSI in a contemporary and multicentric cohort of general, orthopedic trauma and vascular surgery procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No drainage | – | –Those patients that underwent surgery and no drain was inserted at the end of the procedure |
| Drainage | – | Procedure: Insertion of drainageThose patients that underwent surgery and one or several drains were inserted at the end of the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This observational study is nested in a multicenter randomized controlled trial that was designed to evaluate the optimal timing of surgical antimicrobial prophylaxis in a general, orthopedic trauma and vascular surgery population. The term "general surgery" refers to gastrointestinal, oncologic breast, endocrine and hernia surgery. The study centers are two tertiarry referral hospitals in Switzerland. All patients included in the randomized controlled trial are included in this observational study as well.
Key inclusion criteria (4 listed)
- Inpatients
- Age 18 years or older
- General, orthopedic trauma and vascular procedures
- Surgical antimicrobial prophylaxis
Key exclusion criteria (6 listed)
- outpatient surgery
- Presence of a contraindication for cefuroxime and/or metronidazole
- preexisting antibiotic therapy within 14 days prior to surgery
- cognitive impairment
- combined operations including other than the above specified surgical divisions
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 |
|---|---|---|
| Insertion of drainage | Procedure or surgery | Drainage |
Primary outcome
Surgical site infection
Time frame: 30 days
The occurrence of surgical site infection according to CDC criteria
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 24 Jan 2018.
- Background: PubMed 28385346Weber WP, Mujagic E, Zwahlen M, Bundi M, Hoffmann H, Soysal SD, Kraljevic M, Delko T, von Strauss M, Iselin L, Da Silva RXS, Zeindler J, Rosenthal R, Misteli H, Kindler C, Muller P, Saccilotto R, Lugli AK, Kaufmann M, Gurke L, von Holzen U, Oertli D, Bucheli-Laffer E, Landin J, Widmer AF, Fux CA, Marti WR. Timing of surgical antimicrobial prophylaxis: a phase 3 randomised controlled trial. Lancet Infect Dis. 2017 Jun;17(6):605-614. doi: 10.1016/S1473-3099(17)30176-7. Epub 2017 Apr 3.
- Background: PubMed 24885132Mujagic E, Zwimpfer T, Marti WR, Zwahlen M, Hoffmann H, Kindler C, Fux C, Misteli H, Iselin L, Lugli AK, Nebiker CA, von Holzen U, Vinzens F, von Strauss M, Reck S, Kraljevic M, Widmer AF, Oertli D, Rosenthal R, Weber WP. Evaluating the optimal timing of surgical antimicrobial prophylaxis: study protocol for a randomized controlled trial. Trials. 2014 May 24;15:188. doi: 10.1186/1745-6215-15-188.
- Individual participant dataSharing planned: Undecided
Related trials for Surgical Site Infection
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Not yet recruiting
Povidone-Iodine and Ozonated Distilled Water Irrigation in the Management of Maxillofacial Space Infections
Infection, Surgical Site
Not yet recruiting
Suture Choice for Ostomy Creation
Ostomy - Ileostomy or Colostomy, Stoma Complications
Not yet recruitingPhase 3
Evaluation of the Effect of Antibiotic Prophylaxis During Lumpectomy for Breast Cancer: Prospective Randomised Double-blind Noninferiority Study of Placebo vs Cefazolin
Breast Cancer, Breast Surgery
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
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.
Edin Mujagic, MD principal investigator
University Hospital, Basel, Switzerland
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection, run by University Hospital, Basel, Switzerland.
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 4 inclusion and 6 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 24 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Surgical site infection (time frame: 30 days). 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 NCT03408782, 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 24 Jan 2018.