Surgical Wound InfectionPhase 4NCT01980082
Antibiotic Prophylaxis for Revision, Clean Head and Neck Surgery
A Phase 4 study testing Cefazolin in people with Surgical Wound Infection, run by Rabin Medical Center at 1 site in Israel.
Trial summary
We hypothesized that revision clean head \& neck surgery may have a higher rate of wound infection that may be lowered with prophylactic antibiotic treatment. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Cefazolin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to 7 Jul 2017
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous H\&N surgery.
- Planned second H\&N clean surgery (the definition of a second H\&N surgery is a surgery which will include the same skin incision as the previous operation).
Who cannot join
- Previous neck irradiation.
- Tracheostomy status.
- Immunosuppression.
- Concurrent infection which requires antibiotic use.
- Any other factor during the surgery which the surgeon estimates requires prophylactic antibiotic use.
- Allergy to cephalosporins and allergy to penicillin which precludes the use of cephalosporins (e.g. anaphylaxis).
Trial locations and contacts
1 site in 1 country.
About this study
We hypothesized that revision clean head \& neck surgery may have a higher rate of wound infection that may be lowered with prophylactic antibiotic treatment.
Read the detailed description
Surgical wound infection (SWI) is a common complication in many operations, including head and neck (H\&N) surgery, with reported rates ranging between 3.5 to 87%. While prophylactic antibiotic use has been shown to decrease SWI in clean-contaminated and contaminated surgery, its use in clean surgery is debatable. In most types of clean surgery the value of prophylactic antibiotics is minimal, however in some cases it might be justified, including in radical neck dissections, in a previously irradiated neck, those with a tracheostomy and immunosuppressed patients - although there is no consensus regarding these risk factors.
Previous research has shown that adherence to guidelines regarding prophylactic antibiotic use is lacking, with one study showing a greater than 40% rate of inappropriate antibiotic administration. This may be partially attributed to some patients having other risk factors, not covered by existing guidelines.
One such risk factor is previous H\&N surgery. While there are no studies addressing this issue in H\&N surgeries, a study in clean neurosurgical operations has shown an almost trice-fold increase in SWI rates in some operations (4% vs. 13%).
The purpose of this study is to investigate the effect of prophylactic antibiotic use in repeat clean H\&N surgery.
This is a double-blind, randomized, placebo-controlled study. The study will be conducted at the Otolaryngology department in Rabin Medical Center, Petah Tikva.
Patients will be randomly assigned to 2 groups, with each group composed of 50 patients: a study group which will receive 1 dose of intravenous Cefazolin 1 gram/2 gram if body mass index > 40 or a control group which will receive 1 dose of placebo. The drug/placebo will be given 30-60 minutes prior to incision. Previous studies have shown no benefit for longer duration of prophylactic antibiotic coverage. Both the study drug and placebo will be prepared by a designated nurse from the department. The nurse will use a randomization site (www.random.org with min set to 1 and max set to 1000) to give each participant a number. A predefined Excel table will contain an assignment of each number to one of the groups. Only this nurse will know the assignment of each patient and she will not be assessing the patient post-operatively. The patients, surgeons and researchers will be blinded to the patients' assignments.
The status of the surgical wound will be assessed daily during hospitalization and again on the planned follow-up visit 3-4 weeks after discharge. During the follow-up visit, patients will be questions regarding symptoms and signs of SWI and antibiotic prescriptions given during the post-operative period.
SWI diagnosis will be according to the Center for Disease Control's "guideline for surgical site infection". Treatment of SWI will be according to regular department protocols (with no regard to study allocation).
- Conditions
- Surgical Wound Infection
- Being tested
- Cefazolin, Placebo
- Keywords
- head and neck surgery, surgical wound infection, antibiotic prophylaxis
- 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.
CefazolinDrug
Also called Cefamezine
Antibiotic
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Cefazolin | Active comparator | Cefazolin
1 gram/2 gram if body mass index > 40 - one time dose, 30-60 min prior to incision. Receives: Drug: Cefazolin |
| Placebo | Placebo comparator | 1 dose of placebo - NaCl 0.9% with no drugs added to it. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical wound infection, sepsis, bacteremia.
Measured: 1 month from surgery
Secondary outcomes (2)
Length of stay
Length of post-operative stay
Measured: 1 month from surgery
Drug-induced adverse reactions
Measured: 1 month from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startJan 2014
- Primary completion7 Jun 2017
- Study completion7 Jul 2017
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 Wound 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yotam shkedy, Rabin Medical Center
- Investigators
- Yotam Shkedy, MD, Principal investigator, Rabin Medical Center, Petach Tikva, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980082
- Sponsor's protocol ID
- ProphylacticABxHN
- Status last verified
- Feb 2018
- First submitted
- 4 Nov 2013
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Simo R, French G. The use of prophylactic antibiotics in head and neck oncological surgery. Curr Opin Otolaryngol Head Neck Surg. 2006 Apr;14(2):55-61. doi: 10.1097/01.moo.0000193183.30687.d5.
PubMed 16552259Velanovich V. A meta-analysis of prophylactic antibiotics in head and neck surgery. Plast Reconstr Surg. 1991 Mar;87(3):429-34; discussion 435.
PubMed 1825518Seven H, Sayin I, Turgut S. Antibiotic prophylaxis in clean neck dissections. J Laryngol Otol. 2004 Mar;118(3):213-6. doi: 10.1258/002221504322927991.
PubMed 15068519Brown BM, Johnson JT, Wagner RL. Etiologic factors in head and neck wound infections. Laryngoscope. 1987 May;97(5):587-90. doi: 10.1288/00005537-198705000-00009.
PubMed 3573905Tenney JH, Vlahov D, Salcman M, Ducker TB. Wide variation in risk of wound infection following clean neurosurgery. Implications for perioperative antibiotic prophylaxis. J Neurosurg. 1985 Feb;62(2):243-7. doi: 10.3171/jns.1985.62.2.0243.
PubMed 3968563Shkedy Y, Stern S, Nachalon Y, Levi D, Menasherov I, Reifen E, Shpitzer T. Antibiotic prophylaxis in clean head and neck surgery: A prospective randomised controlled trial. Clin Otolaryngol. 2018 Dec;43(6):1508-1512. doi: 10.1111/coa.13195. Epub 2018 Aug 14.
PubMed 30027615
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Prophylaxis for Revision, Clean Head and Neck Surgery
- ClinicalTrials.gov ID
- NCT01980082
- Acronym / sponsor ID
- ProphylacticABxHN
- Conditions
- Surgical Wound Infection
- Keywords
- head and neck surgery, surgical wound infection, antibiotic prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 7 Jun 2017 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 8 Nov 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.
We hypothesized that revision clean head \& neck surgery may have a higher rate of wound infection that may be lowered with prophylactic antibiotic treatment.
Detailed description
Surgical wound infection (SWI) is a common complication in many operations, including head and neck (H\&N) surgery, with reported rates ranging between 3.5 to 87%. While prophylactic antibiotic use has been shown to decrease SWI in clean-contaminated and contaminated surgery, its use in clean surgery is debatable. In most types of clean surgery the value of prophylactic antibiotics is minimal, however in some cases it might be justified, including in radical neck dissections, in a previously irradiated neck, those with a tracheostomy and immunosuppressed patients - although there is no consensus regarding these risk factors.
Previous research has shown that adherence to guidelines regarding prophylactic antibiotic use is lacking, with one study showing a greater than 40% rate of inappropriate antibiotic administration. This may be partially attributed to some patients having other risk factors, not covered by existing guidelines.
One such risk factor is previous H\&N surgery. While there are no studies addressing this issue in H\&N surgeries, a study in clean neurosurgical operations has shown an almost trice-fold increase in SWI rates in some operations (4% vs. 13%).
The purpose of this study is to investigate the effect of prophylactic antibiotic use in repeat clean H\&N surgery.
This is a double-blind, randomized, placebo-controlled study. The study will be conducted at the Otolaryngology department in Rabin Medical Center, Petah Tikva.
Patients will be randomly assigned to 2 groups, with each group composed of 50 patients: a study group which will receive 1 dose of intravenous Cefazolin 1 gram/2 gram if body mass index > 40 or a control group which will receive 1 dose of placebo. The drug/placebo will be given 30-60 minutes prior to incision. Previous studies have shown no benefit for longer duration of prophylactic antibiotic coverage. Both the study drug and placebo will be prepared by a designated nurse from the department. The nurse will use a randomization site (www.random.org with min set to 1 and max set to 1000) to give each participant a number. A predefined Excel table will contain an assignment of each number to one of the groups. Only this nurse will know the assignment of each patient and she will not be assessing the patient post-operatively. The patients, surgeons and researchers will be blinded to the patients' assignments.
The status of the surgical wound will be assessed daily during hospitalization and again on the planned follow-up visit 3-4 weeks after discharge. During the follow-up visit, patients will be questions regarding symptoms and signs of SWI and antibiotic prescriptions given during the post-operative period.
SWI diagnosis will be according to the Center for Disease Control's "guideline for surgical site infection". Treatment of SWI will be according to regular department protocols (with no regard to study allocation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefazolin | Active comparator | Drug: CefazolinCefazolin 1 gram/2 gram if body mass index > 40 - one time dose, 30-60 min prior to incision. |
| Placebo | Placebo comparator | Drug: Placebo1 dose of placebo - NaCl 0.9% with no drugs added to it. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous H\&N surgery.
- Planned second H\&N clean surgery (the definition of a second H\&N surgery is a surgery which will include the same skin incision as the previous operation).
Key exclusion criteria (6 listed)
- Previous neck irradiation.
- Tracheostomy status.
- Immunosuppression.
- Concurrent infection which requires antibiotic use.
- Any other factor during the surgery which the surgeon estimates requires prophylactic antibiotic use.
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 |
|---|---|---|
| CefazolinAlso: CefamezineAntibiotic | Drug | Cefazolin |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Surgical wound infection, sepsis, bacteremia.
Time frame: 1 month from surgery
2 secondary outcomes
Length of stay
Time frame: 1 month from surgery
Drug-induced adverse reactions
Time frame: 1 month from 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 8 Feb 2018.
- Background: PubMed 16552259Simo R, French G. The use of prophylactic antibiotics in head and neck oncological surgery. Curr Opin Otolaryngol Head Neck Surg. 2006 Apr;14(2):55-61. doi: 10.1097/01.moo.0000193183.30687.d5.
- Background: PubMed 1825518Velanovich V. A meta-analysis of prophylactic antibiotics in head and neck surgery. Plast Reconstr Surg. 1991 Mar;87(3):429-34; discussion 435.
- Background: PubMed 15068519Seven H, Sayin I, Turgut S. Antibiotic prophylaxis in clean neck dissections. J Laryngol Otol. 2004 Mar;118(3):213-6. doi: 10.1258/002221504322927991.
- Background: PubMed 3573905Brown BM, Johnson JT, Wagner RL. Etiologic factors in head and neck wound infections. Laryngoscope. 1987 May;97(5):587-90. doi: 10.1288/00005537-198705000-00009.
- Background: PubMed 3968563Tenney JH, Vlahov D, Salcman M, Ducker TB. Wide variation in risk of wound infection following clean neurosurgery. Implications for perioperative antibiotic prophylaxis. J Neurosurg. 1985 Feb;62(2):243-7. doi: 10.3171/jns.1985.62.2.0243.
- Derived from this study: PubMed 30027615Shkedy Y, Stern S, Nachalon Y, Levi D, Menasherov I, Reifen E, Shpitzer T. Antibiotic prophylaxis in clean head and neck surgery: A prospective randomised controlled trial. Clin Otolaryngol. 2018 Dec;43(6):1508-1512. doi: 10.1111/coa.13195. Epub 2018 Aug 14.
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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.
Yotam Shkedy, MD principal investigator
Rabin Medical Center, Petach Tikva, Israel
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 Cefazolin in people with Surgical Wound Infection, run by Rabin Medical Center at 1 site in Israel.
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 2 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 8 Feb 2018. 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 Israel. 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 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?
Surgical wound infection, sepsis, bacteremia. (time frame: 1 month from surgery). 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 NCT01980082, 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 8 Feb 2018.