Pterional CraniotomyEPOPNCT02792361
A Clinical Effectiveness Trial in Post-Operative Pterional Craniotomy Drain Placement
A study testing Standard Suction Drain in people with Pterional Craniotomy, run by University of Arizona.
Trial summary
This is a clinical trial where patients who present to the neurosurgery service in need of a procedure that requires a pterional craniotomy will be screened, and if eligible, enrolled for the randomization in the placement of a drain at the surgical site. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pterional Craniotomy
- What is being tested?
- Standard Suction Drain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients that have been scheduled for surgery requiring the use of a pterional craniotomy approach
Who cannot join
- Patients in need of a surgical intervention requiring a pterional craniotomy due to reasons of physical injury
- Patients who need a pterional craniotomy with a orbitozygomatic approach
- Patients who have noticeable physical injury to their skull
- Patients with a prior surgical history of a craniotomy
- Patients with a pathological condition deemed severe enough by the screening physician to possibly influence the healing process of the procedure (blood clot disorder, cirrhosis, severe nutrient depletion, congestive heart failure etc.)
About this study
Official title: A Randomized, Non-Blind, Clinical Effectiveness Trial in Post-Operative Pterional Craniotomy Drain Placement
This is a clinical trial where patients who present to the neurosurgery service in need of a procedure that requires a pterional craniotomy will be screened, and if eligible, enrolled for the randomization in the placement of a drain at the surgical site. At present, there is not a protocol for whether or not to use a drain following this procedure. There is some debate on whether it serves any real benefit for the patient or if it may actually be detrimental in cases where infection occurs. This study aims to answer this question by randomizing patients to drain placement and then comparing patient outcomes between the two groups. These include the following: infection rate, length of hospital stay, self-reported patient pain and discomfort, the amount of time before patients are able to open their eye ipsilateral to the side of operation, change in forehead circumference post-op days 1-3, and any unforeseen post-operative complications. This will be accomplished through using a patient-administered survey, recording physical measurements, and a patient chart review. Statistical analysis will then be used to identify any differences that may exist.
- Conditions
- Pterional Craniotomy
- Being tested
- Standard Suction Drain
- Keywords
- Post-Operative Pterional Craniotomy, Suction Drain, Benefits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Suction DrainProcedure or surgery
The intervention of the experimental group will be a standard suction drain placed at the surgical site following a Pterional Craniotomy.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Subjects who did not have a suction drain placed post-operatively following a Pterional Craniotomy. |
| Treatment Group | Experimental | Subjects who did have a suction drain placed post-operatively following a Pterional Craniotomy at the location of surgical incision. Receives: Procedure: Standard Suction Drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Length of Hospital Stay
Compare the length of hospital between the treatment groups and determine whether a significant difference exists.
Measured: From the date of surgery to the date of discharge from the hospital for up to 16 weeks following surgery, or until death, depending which comes first.
Head Circumference Difference
Compare the change in measured forehead circumference between treatment groups on post-operative days 1-3. Determine if a significant difference exists between the two.
Measured: Day 1 through Day 3 following surgery.
Pain Difference
Compare the reported pain/ discomfort between the patients who had drain placement from those who did not. This will be performed using a survey administered to patients upon removal of the drain
Measured: At the time of discharge from the hospital but no longer than up to 16 weeks from the date of surgery.
Ability to open ipsilateral eye to surgical site.
Compare the number of subjects able to open and close their eye on the ipsilateral side of the surgical site between the study groups
Measured: Day 1 through Day 3 following surgery.
Complication Rate
An overall assessment comparing complications between the two study groups will be performed. This will include looking things such as hospital acquired pneumonia, the development of any new neurological conditions or deficiencies, and other unforeseen complications that may arise which are not be directly related to the drain but may potentially still be influenced by it.
Measured: From the date of surgery to the date of discharge from the hospital for up to 16 weeks following surgery, or until death, depending which comes first.
Surgical site infection rate
Compare infections rates between patients with drains placement versus those who did not. Determine if there is any statistically significant difference in risk exists between the two study populations.
Measured: From the date of surgery to the date of discharge from the hospital for up to 16 weeks following surgery, or until death, depending which comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pterional CraniotomyStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wyatt Ramey, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792361
- Sponsor's protocol ID
- SCT1121
- Acronym
- EPOP
- Status last verified
- May 2016
- First submitted
- 25 May 2016
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be made available. However, findings may be published in a peer-reviewed academic journal.
Publications
Chaddad-Neto F, Campos Filho JM, Doria-Netto HL, Faria MH, Ribas GC, Oliveira E. The pterional craniotomy: tips and tricks. Arq Neuropsiquiatr. 2012 Sep;70(9):727-32. doi: 10.1590/s0004-282x2012000900015.
PubMed 22990732Dougherty SH, Simmons RL. The biology and practice of surgical drains. Part II. Curr Probl Surg. 1992 Sep;29(9):633-730. doi: 10.1016/0011-3840(92)90028-2. No abstract available.
PubMed 1424760Cruse PJ, Foord R. A five-year prospective study of 23,649 surgical wounds. Arch Surg. 1973 Aug;107(2):206-10. doi: 10.1001/archsurg.1973.01350200078018. No abstract available.
PubMed 4719566Mollman HD, Haines SJ. Risk factors for postoperative neurosurgical wound infection. A case-control study. J Neurosurg. 1986 Jun;64(6):902-6. doi: 10.3171/jns.1986.64.6.0902.
PubMed 3701440
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Non-Blind, Clinical Effectiveness Trial in Post-Operative Pterional Craniotomy Drain Placement
- ClinicalTrials.gov ID
- NCT02792361
- Acronym / sponsor ID
- EPOP / SCT1121
- Conditions
- Pterional Craniotomy
- Keywords
- Post-Operative Pterional Craniotomy, Suction Drain, Benefits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 7 Jun 2016 (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.
This is a clinical trial where patients who present to the neurosurgery service in need of a procedure that requires a pterional craniotomy will be screened, and if eligible, enrolled for the randomization in the placement of a drain at the surgical site. At present, there is not a protocol for whether or not to use a drain following this procedure. There is some debate on whether it serves any real benefit for the patient or if it may actually be detrimental in cases where infection occurs. This study aims to answer this question by randomizing patients to drain placement and then comparing patient outcomes between the two groups. These include the following: infection rate, length of hospital stay, self-reported patient pain and discomfort, the amount of time before patients are able to open their eye ipsilateral to the side of operation, change in forehead circumference post-op days 1-3, and any unforeseen post-operative complications. This will be accomplished through using a patient-administered survey, recording physical measurements, and a patient chart review. Statistical analysis will then be used to identify any differences that may exist.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Subjects who did not have a suction drain placed post-operatively following a Pterional Craniotomy. |
| Treatment Group | Experimental | Procedure: Standard Suction DrainSubjects who did have a suction drain placed post-operatively following a Pterional Craniotomy at the location of surgical incision. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that have been scheduled for surgery requiring the use of a pterional craniotomy approach
Key exclusion criteria (5 listed)
- Patients in need of a surgical intervention requiring a pterional craniotomy due to reasons of physical injury
- Patients who need a pterional craniotomy with a orbitozygomatic approach
- Patients who have noticeable physical injury to their skull
- Patients with a prior surgical history of a craniotomy
- Patients with a pathological condition deemed severe enough by the screening physician to possibly influence the healing process of the procedure (blood clot disorder, cirrhosis, severe nutrient depletion, congestive heart failure etc.)
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 |
|---|---|---|
| Standard Suction DrainThe intervention of the experimental group will be a standard suction drain placed at the surgical site following a Pterional Craniotomy. | Procedure or surgery | Treatment Group |
Primary outcome
Difference in Length of Hospital Stay
Time frame: From the date of surgery to the date of discharge from the hospital for up to 16 weeks following surgery, or until death, depending which comes first.
Compare the length of hospital between the treatment groups and determine whether a significant difference exists.
Head Circumference Difference
Time frame: Day 1 through Day 3 following surgery.
Compare the change in measured forehead circumference between treatment groups on post-operative days 1-3. Determine if a significant difference exists between the two.
Pain Difference
Time frame: At the time of discharge from the hospital but no longer than up to 16 weeks from the date of surgery.
Compare the reported pain/ discomfort between the patients who had drain placement from those who did not. This will be performed using a survey administered to patients upon removal of the drain
Ability to open ipsilateral eye to surgical site.
Time frame: Day 1 through Day 3 following surgery.
Compare the number of subjects able to open and close their eye on the ipsilateral side of the surgical site between the study groups
Complication Rate
Time frame: From the date of surgery to the date of discharge from the hospital for up to 16 weeks following surgery, or until death, depending which comes first.
An overall assessment comparing complications between the two study groups will be performed. This will include looking things such as hospital acquired pneumonia, the development of any new neurological conditions or deficiencies, and other unforeseen complications that may arise which are not be directly related to the drain but may potentially still be influenced by it.
Surgical site infection rate
Time frame: From the date of surgery to the date of discharge from the hospital for up to 16 weeks following surgery, or until death, depending which comes first.
Compare infections rates between patients with drains placement versus those who did not. Determine if there is any statistically significant difference in risk exists between the two study populations.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
- Background: PubMed 22990732Chaddad-Neto F, Campos Filho JM, Doria-Netto HL, Faria MH, Ribas GC, Oliveira E. The pterional craniotomy: tips and tricks. Arq Neuropsiquiatr. 2012 Sep;70(9):727-32. doi: 10.1590/s0004-282x2012000900015.
- Background: PubMed 1424760Dougherty SH, Simmons RL. The biology and practice of surgical drains. Part II. Curr Probl Surg. 1992 Sep;29(9):633-730. doi: 10.1016/0011-3840(92)90028-2. No abstract available.
- Background: PubMed 4719566Cruse PJ, Foord R. A five-year prospective study of 23,649 surgical wounds. Arch Surg. 1973 Aug;107(2):206-10. doi: 10.1001/archsurg.1973.01350200078018. No abstract available.
- Background: PubMed 3701440Mollman HD, Haines SJ. Risk factors for postoperative neurosurgical wound infection. A case-control study. J Neurosurg. 1986 Jun;64(6):902-6. doi: 10.3171/jns.1986.64.6.0902.
- Individual participant dataSharing planned: No. Individual participant data will not be made available. However, findings may be published in a peer-reviewed academic journal.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Suction Drain in people with Pterional Craniotomy, run by University of Arizona.
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 5 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: status not confirmed, as of the sponsor's last update on 7 Jun 2016. 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?
Results are not available in the source record.
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?
Difference in Length of Hospital Stay (time frame: From the date of surgery to the date of discharge from the hospital for up to 16 weeks following surgery, or until death, depending which comes first.). The study lists 6 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 NCT02792361, which also lists 4 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 7 Jun 2016.