Surgical Site InfectionsNCT01971138

Review of Surgical Site Infection Registration Routine at Surgery Departments in Sweden and Validation of One of the Used Routines

An observational study of Surgical Site Infections, run by Halmstad County Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study explores the routines of registration of surgical site infections (SSI) at different surgical centers in Sweden. It explores the sensitivity and specificity of the registration routines of SSI are at Halmstad County Hospital, Sweden. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Surgical Site Infections
What is being tested?: this is a survey
How many people: Not given
Where: 1 siteSweden
Study dates: Mar 2013to Apr 2013
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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Study population: Surgical clinics in Sweden.

Who may be able to join

Surgical Clinics in Sweden that report tho the Swedish national register for Colorectal Cancer.

Who cannot join

Clinics that dosen´t report.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Halmstad County Hospital
Halmstad, Halland County, 30232

Other trials in Sweden

About this study

Conditions: Surgical Site Infections
Being tested: this is a survey
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.

this is a surveyOther

Study groups in NCT01971138
Study group	Role	What they receive
Surgical site infection registration		Is there a routine for SSI registration Receives: Other: this is a survey

What is being measured

The primary outcome is the main question the study is designed to answer.

In which proportion do surgical clinics in Sweden register Surgical Site Infections
A questionnaire will be sent to every surgical clinic in Sweden. This study will then summarize in what way the surgical clinics in Sweden perform their SSI surveillance.
Measured: spring 2013
In which proportion does the routine SSI registration at Halmstad County Hospital register the actual number of SSI´s.
Aiming to validate the SSI surveillance at Halmstad County Hospital. Patients who underwent elective colorectal resection between 2007-2008 were identified for inclusion in the study. A total of 66 patient were included. They were followed prospectively for four weeks and were controlled daily regarded SSI as a part of the study. After these four weeks the patients also filled a form regarding SSI. This group where then used as a control group. The results from the SSI registration routine at Halmstad County Hospital were then compared with the control group regarded SSI.
Measured: up to four years

Secondary outcomes (4)

Which method is used for routine registration of SSI´s in Sweden.
A questionnaire will be sent to every surgical clinic in Sweden. This study will then summarize in what way the surgical clinics in Sweden perform their SSI surveillance.
Measured: spring 2013
How is the SSI classified in different hospitals in Sweden.
A questionnaire will be sent to every surgical clinic in Sweden. This study will then summarize in what way the surgical clinics in Sweden perform their SSI surveillance.
Measured: spring 2013
How is the variation of SSI at the surgical clinic in Halmstad County Hospital, Sweden, the last 10 years.
The study aims to do a statistical Analysis of the SSI surveillance material collected at the Halmstad County Hospital between 2002-2012. We want to know how big the variation is between years regarding SSI and if the statistics i good enough to draw conclusions from.
Measured: for 10 years
How large the difference have to be between in registered SSI frequency to surely detect a deviation in SSI presence
The study aims to do a statistical Analysis of the SSI surveillance material collected at the Halmstad County Hospital between 2002-2012. We want to know how big the variation is between years regarding SSI and if the statistics i good enough to draw conclusions from.
Measured: for 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Apr 2013

First posted29 Oct 2013 (estimated)
Study startMar 2013
Primary completionApr 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Surgical Site InfectionsStudies 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
Time perspective: Retrospective

IDs, dates and publications

ClinicalTrials.gov ID: NCT01971138
Sponsor's protocol ID: 121020-V02
Status last verified: Oct 2013
First submitted: 28 Aug 2013
Last updated: 29 Oct 2013
Results posted: No
Data monitoring committee: No

Publications

Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. doi: 10.1086/501572.
PubMed 10580621
Smyth ET, Emmerson AM. Surgical site infection surveillance. J Hosp Infect. 2000 Jul;45(3):173-84. doi: 10.1053/jhin.2000.0736.
PubMed 10896795
Degrate L, Garancini M, Misani M, Poli S, Nobili C, Romano F, Giordano L, Motta V, Uggeri F. Right colon, left colon, and rectal surgeries are not similar for surgical site infection development. Analysis of 277 elective and urgent colorectal resections. Int J Colorectal Dis. 2011 Jan;26(1):61-9. doi: 10.1007/s00384-010-1057-8. Epub 2010 Oct 5.
PubMed 20922541
Malone DL, Genuit T, Tracy JK, Gannon C, Napolitano LM. Surgical site infections: reanalysis of risk factors. J Surg Res. 2002 Mar;103(1):89-95. doi: 10.1006/jsre.2001.6343.
PubMed 11855922
Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.
PubMed 10196487
Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Am J Infect Control. 1992 Oct;20(5):271-4. doi: 10.1016/s0196-6553(05)80201-9. No abstract available.
PubMed 1332552

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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)
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RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
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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
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All Surgical Site Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Review of Surgical Site Infection Registration Routine at Surgery Departments in Sweden and Validation of One of the Used Routines
ClinicalTrials.gov ID: NCT01971138
Acronym / sponsor ID: 121020-V02
Conditions: Surgical Site Infections
Study type: Observational
Recruitment status: Completed
Lead sponsor: Halmstad County HospitalUniversity, hospital or other
Study start: Mar 2013
Primary completion: Apr 2013 (actual)
First posted: 29 Oct 2013 (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.

Study design

Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Surgical site infection registration	–	Other: this is a surveyIs there a routine for SSI registration

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Surgical clinics in Sweden.

Key inclusion criteria (1 listed)

Surgical Clinics in Sweden that report tho the Swedish national register for Colorectal Cancer.

Key exclusion criteria (1 listed)

Clinics that dosen´t report.

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
this is a survey	Other	Surgical site infection registration

Primary outcome

In which proportion do surgical clinics in Sweden register Surgical Site Infections
Time frame: spring 2013
A questionnaire will be sent to every surgical clinic in Sweden. This study will then summarize in what way the surgical clinics in Sweden perform their SSI surveillance.
In which proportion does the routine SSI registration at Halmstad County Hospital register the actual number of SSI´s.
Time frame: up to four years
Aiming to validate the SSI surveillance at Halmstad County Hospital. Patients who underwent elective colorectal resection between 2007-2008 were identified for inclusion in the study. A total of 66 patient were included. They were followed prospectively for four weeks and were controlled daily regarded SSI as a part of the study. After these four weeks the patients also filled a form regarding SSI. This group where then used as a control group. The results from the SSI registration routine at Halmstad County Hospital were then compared with the control group regarded SSI.

4 secondary outcomes

Which method is used for routine registration of SSI´s in Sweden.
Time frame: spring 2013
How is the SSI classified in different hospitals in Sweden.
Time frame: spring 2013
How is the variation of SSI at the surgical clinic in Halmstad County Hospital, Sweden, the last 10 years.
Time frame: for 10 years
How large the difference have to be between in registered SSI frequency to surely detect a deviation in SSI presence
Time frame: for 10 years

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 29 Oct 2013.
Background: PubMed 10580621Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. doi: 10.1086/501572.
Background: PubMed 10896795Smyth ET, Emmerson AM. Surgical site infection surveillance. J Hosp Infect. 2000 Jul;45(3):173-84. doi: 10.1053/jhin.2000.0736.
Background: PubMed 20922541Degrate L, Garancini M, Misani M, Poli S, Nobili C, Romano F, Giordano L, Motta V, Uggeri F. Right colon, left colon, and rectal surgeries are not similar for surgical site infection development. Analysis of 277 elective and urgent colorectal resections. Int J Colorectal Dis. 2011 Jan;26(1):61-9. doi: 10.1007/s00384-010-1057-8. Epub 2010 Oct 5.
Background: PubMed 11855922Malone DL, Genuit T, Tracy JK, Gannon C, Napolitano LM. Surgical site infections: reanalysis of risk factors. J Surg Res. 2002 Mar;103(1):89-95. doi: 10.1006/jsre.2001.6343.
Background: PubMed 10196487Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.
Background: PubMed 1332552Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Am J Infect Control. 1992 Oct;20(5):271-4. doi: 10.1016/s0196-6553(05)80201-9. No abstract available.

Related trials for Surgical Site Infections

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
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
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

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.

Claes Hjalmarsson, MD, PhD principal investigator

Halmstad County Hospital, Halmstad, Sweden

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Surgical Site Infections, run by Halmstad County 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 29 Oct 2013. 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.

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?

In which proportion do surgical clinics in Sweden register Surgical Site Infections (time frame: spring 2013). The study lists 2 primary outcomes in all. 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 NCT01971138, which also lists 6 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 29 Oct 2013.