Surgical Site InfectionNCT02961244

Effect of Standard Normothermia Protocol On Surgical Site Infections

A study testing Prewarming and perioperative warming with Forced Air Warming device and its blankets. and Forced Air Warming blanket in people with Surgical Site Infection, run by Dokuz Eylul University.

Completed

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

Official record

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Trial summary

Aim of this study is to investigate the efficiency of a standard normothermia protocol and effects on postoperative Surgical Site Infection (SSI) rate. 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?: Prewarming and perioperative warming with Forced Air Warming device and its blankets. and Forced Air Warming blanket
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: No sites listed yet
Study dates: Jun 2013to Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Elective
Preoperatively not infected/dirty Surgical Site
Open major abdominal operations (hepatobiliary, upper gastrointestinal or colorectal); under general anesthesia, longer than 30 minutes)

Who cannot join

Emergent surgery
Local/locoregional procedures
Laparoscopic operation
Minor abdominal operations (e.g. hernia repair, colostomy closure)
Malign hyperthermia
Signs of active infection or fever

Show all 9Show fewer

Immunosuppression
Severe malnutrition
Kidney/liver failure and antibiotic use within the previous 1 week or immunosuppressive use (chemotherapy, steroids.) within the previous 1 month and reversal of patients opinion while randomization period

About this study

Official title: Effect of Standard Normothermia Protocol On Surgical Site Infections: Randomized Controlled Trial

Aim of this study is to investigate the efficiency of a standard normothermia protocol and effects on postoperative Surgical Site Infection (SSI) rate.

Conditions: Surgical Site Infection
Being tested: Prewarming and perioperative warming with Forced Air Warming device and its blankets., Forced Air Warming blanket
Keywords: Surgical Site Infection, normothermia, hypothermia, prewarming
Medical subject headings: Surgical Wound Infection, Hypothermia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prewarming and perioperative warming with Forced Air Warming device and its blankets.Other
Forced Air Warming blanketDevice

Study groups in NCT02961244
Study group	Role	What they receive
Control Group	No intervention	Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
Intervention Group	Active comparator	Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming. Receives: Other: Prewarming and perioperative warming with Forced Air Warming device and its blankets.; Device: Forced Air Warming blanket

What is being measured

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

Surgical Site Infection Rate
Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed.
All patients were made enough incision wide to explore their entire abdomen defined as "Major Abdominal Surgery" .
With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n<30), (p=0.044 chi-square )
Measured: Postoperative 30 days

Secondary outcomes (1)

Maintaining Normothermia Rate
Within the surgery day, from patient bed through the operating room to PACU or ICU or back to patient bed.
With these results our intervention group's maintaining normothermia rates were higher respectively. ( p=0.001) For each patients around 11 temperature measurement had been made according to the operation time . If any measurement of any patients was <36 ºC , that patient accepted as hypothermic. (Failure to maintain normothermia)
Measured: Surgery day

Timeline

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

Jun 2013Jun 2016

First posted10 Nov 2016 (estimated)
Study startJun 2013
Primary completionDec 2015
Study completionJun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (39)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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02961244
Sponsor's protocol ID: 870-GOA
Status last verified: Nov 2017
First submitted: 1 Nov 2016
Last updated: 12 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes

Publications

Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.
PubMed 19137809
Sessler DI. Perioperative thermoregulation. Geriatr Anesthesiol. 2008;6736(15):107-22
Horosz B, Malec-Milewska M. Inadvertent intraoperative hypothermia. Anaesthesiol Intensive Ther. 2013 Jan-Mar;45(1):38-43. doi: 10.5603/AIT.2013.0009.
PubMed 23572308
Doufas AG. Consequences of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):535-49. doi: 10.1016/s1521-6896(03)00052-1.
PubMed 14661656
Clinical practice guideline: The management of inadvertent perioperative hypothermia in adults National Collaborating Centre for Nursing and Supportive Care commissioned by National Institute for Health and Clinical Excellence. 2008;88-92, 204-445
Putzu M, Casati A, Berti M, Pagliarini G, Fanelli G. Clinical complications, monitoring and management of perioperative mild hypothermia: anesthesiological features. Acta Biomed. 2007 Dec;78(3):163-9.
PubMed 18330074
Reynolds L, Beckmann J, Kurz A. Perioperative complications of hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):645-57. doi: 10.1016/j.bpa.2008.07.005.
PubMed 19137808
Leslie K, Sessler DI. Perioperative hypothermia in the high-risk surgical patient. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):485-98. doi: 10.1016/s1521-6896(03)00049-1.
PubMed 14661653
Torossian A, Brauer A, Hocker J, Bein B, Wulf H, Horn EP. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015 Mar 6;112(10):166-72. doi: 10.3238/arztebl.2015.0166.
PubMed 25837741
Kurz A. Thermal care in the perioperative period. Best Pract Res Clin Anaesthesiol. 2008 Mar;22(1):39-62. doi: 10.1016/j.bpa.2007.10.004.
PubMed 18494388
Leslie K, Sessler DI, Bjorksten AR, Moayeri A. Mild hypothermia alters propofol pharmacokinetics and increases the duration of action of atracurium. Anesth Analg. 1995 May;80(5):1007-14. doi: 10.1097/00000539-199505000-00027.
PubMed 7726398
Fritz HG, Holzmayr M, Walter B, Moeritz KU, Lupp A, Bauer R. The effect of mild hypothermia on plasma fentanyl concentration and biotransformation in juvenile pigs. Anesth Analg. 2005 Apr;100(4):996-1002. doi: 10.1213/01.ANE.0000146517.17910.54.
PubMed 15781513
Polderman KH. Mechanisms of action, physiological effects, and complications of hypothermia. Crit Care Med. 2009 Jul;37(7 Suppl):S186-202. doi: 10.1097/CCM.0b013e3181aa5241.
PubMed 19535947
Liu M, Hu X, Liu J. The effect of hypothermia on isoflurane MAC in children. Anesthesiology. 2001 Mar;94(3):429-32. doi: 10.1097/00000542-200103000-00011.
PubMed 11374601
Mauermann WJ, Nemergut EC. The anesthesiologist's role in the prevention of surgical site infections. Anesthesiology. 2006 Aug;105(2):413-21; quiz 439-40. doi: 10.1097/00000542-200608000-00025. No abstract available.
PubMed 16871076

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?

Official record

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All Surgical Site Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Standard Normothermia Protocol On Surgical Site Infections: Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02961244
Acronym / sponsor ID: 870-GOA
Conditions: Surgical Site Infection
Keywords: Surgical Site Infection, normothermia, hypothermia, prewarming
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: Dokuz Eylul UniversityUniversity, hospital or other
Study start: Jun 2013
Primary completion: Dec 2015 (actual)
Study completion: Jun 2016 (actual)
First posted: 10 Nov 2016 (estimated)
Results: Posted 11 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Aim of this study is to investigate the efficiency of a standard normothermia protocol and effects on postoperative Surgical Site Infection (SSI) rate.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control Group	No intervention	–Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
Intervention Group	Active comparator	Other: Prewarming and perioperative warming with Forced Air Warming device and its blankets., Device: Forced Air Warming blanketPerioperative management and warming was performed according to a standard normothermia protocol with active prewarming.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Elective
Preoperatively not infected/dirty Surgical Site
Open major abdominal operations (hepatobiliary, upper gastrointestinal or colorectal); under general anesthesia, longer than 30 minutes)

Key exclusion criteria (9 listed)

Emergent surgery
Local/locoregional procedures
Laparoscopic operation
Minor abdominal operations (e.g. hernia repair, colostomy closure)
Malign hyperthermia

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
Prewarming and perioperative warming with Forced Air Warming device and its blankets.	Other	Intervention Group
Forced Air Warming blanket	Device	Intervention Group

Primary outcome

Surgical Site Infection Rate
Time frame: Postoperative 30 days
Within the postoperative 30 days, if there is purulent exudate or nonpurulent but culture was pozitive, we accepted them as Surgical Site Infection (SSI) diagnosed. All patients were made enough incision wide to explore their entire abdomen defined as "Major Abdominal Surgery" . With this results between two groups intervention group had lesser rates of SSI respectively( (p=0.045 Mann Whitney U, n<30), (p=0.044 chi-square )

1 secondary outcome

Maintaining Normothermia Rate
Time frame: Surgery day

Results and safety

Results posted to the registry on 11 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group	64	63
Intervention Group	64	55

Primary outcome: Surgical Site Infection Rate

Time frame: Postoperative 30 days. Count of participants. Unit: Participants

Measure	Control Group n = 63	Intervention Group n = 55
Value	19	8

Population analysed: Patients and their results assessed on the basis of intention to treat per protocole.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Within the postoperative 30 days. Other adverse events reported at 0.008% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group	0 of 63 (0%)	0 of 63 (0%)	Not reported
Intervention Group	0 of 55 (0%)	1 of 55 (1.8%)	Not reported

Limitations and caveats (from the sponsor): Surgical etiologies were various.It was a single-centered trial whose power was 80%.The room temperatures could not be kept constant.The number of samples were not enough to make variate analysis of SSI and hypothermia risk factors.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19137809Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.
BackgroundSessler DI. Perioperative thermoregulation. Geriatr Anesthesiol. 2008;6736(15):107-22
Background: PubMed 23572308Horosz B, Malec-Milewska M. Inadvertent intraoperative hypothermia. Anaesthesiol Intensive Ther. 2013 Jan-Mar;45(1):38-43. doi: 10.5603/AIT.2013.0009.
Background: PubMed 14661656Doufas AG. Consequences of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):535-49. doi: 10.1016/s1521-6896(03)00052-1.
BackgroundClinical practice guideline: The management of inadvertent perioperative hypothermia in adults National Collaborating Centre for Nursing and Supportive Care commissioned by National Institute for Health and Clinical Excellence. 2008;88-92, 204-445
Background: PubMed 18330074Putzu M, Casati A, Berti M, Pagliarini G, Fanelli G. Clinical complications, monitoring and management of perioperative mild hypothermia: anesthesiological features. Acta Biomed. 2007 Dec;78(3):163-9.
Background: PubMed 19137808Reynolds L, Beckmann J, Kurz A. Perioperative complications of hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):645-57. doi: 10.1016/j.bpa.2008.07.005.
Background: PubMed 14661653Leslie K, Sessler DI. Perioperative hypothermia in the high-risk surgical patient. Best Pract Res Clin Anaesthesiol. 2003 Dec;17(4):485-98. doi: 10.1016/s1521-6896(03)00049-1.
Background: PubMed 25837741Torossian A, Brauer A, Hocker J, Bein B, Wulf H, Horn EP. Preventing inadvertent perioperative hypothermia. Dtsch Arztebl Int. 2015 Mar 6;112(10):166-72. doi: 10.3238/arztebl.2015.0166.
Background: PubMed 18494388Kurz A. Thermal care in the perioperative period. Best Pract Res Clin Anaesthesiol. 2008 Mar;22(1):39-62. doi: 10.1016/j.bpa.2007.10.004.
Background: PubMed 7726398Leslie K, Sessler DI, Bjorksten AR, Moayeri A. Mild hypothermia alters propofol pharmacokinetics and increases the duration of action of atracurium. Anesth Analg. 1995 May;80(5):1007-14. doi: 10.1097/00000539-199505000-00027.
Background: PubMed 15781513Fritz HG, Holzmayr M, Walter B, Moeritz KU, Lupp A, Bauer R. The effect of mild hypothermia on plasma fentanyl concentration and biotransformation in juvenile pigs. Anesth Analg. 2005 Apr;100(4):996-1002. doi: 10.1213/01.ANE.0000146517.17910.54.
Individual participant dataSharing planned: Yes

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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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Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
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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.

Mustafa Cem Terzi, Proffessor Doctor study director

Dokuz Eylul School of Medicine, General Surgery, Colorectal and Pelvic Diseases Department

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 9 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 12 Dec 2017. 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?

Yes. Results are posted in the registry (first posted 11 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Rate (time frame: Postoperative 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 NCT02961244, which also lists 39 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 12 Dec 2017.