Prophylactic Use of Dural Tenting Sutures in Elective Craniotomies - is it Necessary? A Multicentre Randomised Study.
Phase: NA
Conditions: Epidural Hematoma
Sponsor: Medical University of Warsaw

 
 
 
 
STUDY PROTOCOL 
14/01/2020 
Prophylactic Use of Dural 
Tenting Sutures in Elective 
Craniotomies – Is It Necessary? 
A multicenter Randomised 
Study. 
Banacha 1a St. 
02-097 Warsaw, Poland 
tel.+48 22 59 92 575 
faks +48 22 59 91 574 
neurochirurgia@wum.edu.pl
https://neurochirurgia.wum.edu.pl/
 

PG. 1 
 
 
1. Study Identification 
 
Unique Protocol identification Number: 
KB/106/2018 
Brief Title: 
Dural tenting sutures in neurosurgery - is it necessary? 
Official Title: 
Prophylactic use of dural tenting sutures in elective craniotomies - is it necessary? A multicentre 
randomised study. 
Acronym: 
Study Type:  
Interventional 
 
2. STUDY STATUS 
 
Record Verification Date: 
June 2018 
Overall Recruitment Status:  
Recruiting 
Study Start Date: 
September 7, 2018 
Primary Completion Date: 
Anticipated September 1, 2021 
Study Completion Date: 
Anticipated April 1, 2022 
 
3. SPONSOR/COLLABORATORS 
 
Responsible Party, by Official Title: 
Sponsor  
Investigator Information: 
Investigator Name: 
Przemysław Kunert 

PG. 2 
 
Investigator Official Title: 
 
MD, PhD, Vice Chair of Department of Neurosurgery 
Investigator Affiliation: 
Department of Neurosurgery, Medical University of Warsaw 
Investigator Information: 
Investigator Name: 
Łukasz Przepiórka 
Investigator Official Title: 
 
Investigator Affiliation: 
Department of Neurosurgery, Medical University of Warsaw 
 
Name of the Sponsor: 
Medical University of Warsaw 
 
4. OVERSIGHT 
 
Studies a U.S. FDA-regulated Drug Product: 
No  
Studies a U.S. FDA-regulated Device Product: 
No  
Device Product Not Approved or Cleared by U.S. FDA: 
No  
Post Prior US FDA Approval or Clearance: 
No  
Investigational New Drug Application(IND)/Investigational Device Exemption (IDE) Information: 
U.S. Food and Drug Administration IND or IDE: 
No 
Human Subjects Review: 
Human Subjects Protection Review Board Status:  
Submitted, approved 
Board Approval Number: 
KB / 106 / 2018 
Board Name: 
Komisja Bioetyczna przy Warszawskim Uniwersytecie Medycznym 
(Bioetics Comitee, Medical University of Warsaw) 

PG. 3 
 
Board Affiliation: 
Medical University of Warsaw 
Board Contact: 
Phone: 
+48 22 57 20 30 
Email: 
komisja.bioetyczna@wum.edu.pl 
Address: 
ul. Żwirki I Wigury nr 61, 02-091 Warszawa 
Data Monitoring Committee: 
Yes  
FDA Regulated Intervention:  
No 
Section 801 Clinical Trial: 
No 
 
5. STUDY DESCRIPTION 
 
Brief Summary (using lay language:) 
This study evaluates the necessity of dural tenting sutures in craniotomies. The sutures elevate the 
dura, a layer between the brain and skull. Supposedly, by doing so, they prevent blood collecting 
between dura mater and the skull. These blood collections, called epidural hematomas, 
contributed greatly to postoperative mortality in the early days of neurosurgery. There have been 
several reports questioning the ongoing need for them in neurosurgery, thanks to modern 
hemostatic techniques. Moreover, it has been published in the literature, and is a common 
knowledge as well, that some neurosurgeons do not use these sutures at all, and do not have 
worse outcomes than their colleagues. 
In this study, half of the randomly assigned participants will undergo craniotomy without dural 
tenting sutures and will be considered an intervention group. The other half will undergo 
craniotomy with these sutures. 
Detailed Description: 
In the early days of neurosurgery, epidural hemorrhages (EDH) contributed to a high mortality rate 
after craniotomies. Almost a century ago Walter Dandy reported dural tenting sutures as an 
effective way of preventing postoperative EDH. Over time, his technique gained in popularity and 
significance to finally become a neurosurgical standard. 
Yet, there have been several retrospective reports questioning the ongoing need for dural tenting 
sutures. Dandy's explanation that the hemostasis under hypotensive conditions is deceiving and 
eventually causes EDH may be obsolete. These days, proper intra- and postoperative care, 
including maintenance of normovolemia and normotension and the use of modern hemostatic 
agents, may be enough for effective hemostasis. Evading of this suturing technique by some 
surgeons supports this argument even further. 
Thus, there is a fundamental need to evaluate the necessity of dural tenting sutures in an 
unbiased, evidence-based manner. 
 

PG. 4 
 
6. CONDITIONS AND KEYWORDS 
 
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study: 
1. Epidural Hematoma 
Keywords: 
1. Craniotomy 
2. Dural Tenting Suture 
3. Epidural Hematoma 
 
7. STUDY DESIGN (INTERVENTIONAL) 
 
Primary purpose: 
Prevention 
Study Phase:  
N/A 
Interventional Study Model:  
Parallel 
Model Description: 
We plan to include 2000 subjects in this study. Each subject will undergo a craniotomy for 
unrelated pathology. Each of the subjects will be assigned in random order to an intervention or 
control group. The intervention group will not have dural tenting sutures during closure of their 
craniotomy while the control group will have at least three. 
Both groups will be followed radiologically and clinically, in the exact same manner. 
Number of Arms: 
2 
Masking Roles, if Masking: 
Participant 
Investigator 
Outcomes Assessor 
Masking Description: 
Due to the nature of the surgical procedures, the surgeon and the rest of the OR medical team will 
be aware of the current subject’s allocation. However, in each case, the specific OR team aware 
of the subject’s allocation will be different from the investigators performing further evaluation of 
the given subject. The following study procedures will be in place to ensure double-blind 
administration of the study.   
• 
Access to the randomization code will be strictly controlled.   
• 
The surgeon will receive information on subject’s allocation after commencing the 
surgery. 
The study blind will be broken:  
1. 
During interim monitoring, after recruiting the first 100 patients. 

PG. 5 
 
2. 
On completion of the clinical study and after the study database has been locked. 
3. 
When patients’ safety requires access to allocation data. 
Allocation: 
Randomized 
Enrollment Type: 
Anticipated 
Number of Participants: 
2 000 
 
 
8. ARMS, GROUPS, AND INTERVENTIONS 
 
Arm 1: 
Arm Type:  
No intervention 
Arm Title: 
No dural tenting sutures  
Arm Description: 
No dural tenting techniques 
Arm 2: 
Arm Type:  
Active Comparator  
Arm Title: 
Dural tenting sutures 
Arm Description: 
Dural tenting techniques 
 
 
 
Intervention 1: 
Intervention Type:  
Procedure/Surgery 
Intervention Name 
No dural tenting techniques  
Other Intervention Name 1: 
No tack-up sutures 
Other Intervention Name 2: 
No hitch-up stitches 

PG. 6 
 
Intervention Description: 
Not applying dural tenting sutures during closure of a craniotomy 
Intervention 2: 
Intervention Type:  
Procedure/Surgery 
Intervention Name 
Dural tenting techniques 
Other Intervention Name 1: 
No tack-up sutures 
Other Intervention Name 2: 
No hitch-up stitches 
Intervention Description: 
Applying at least 3 dural tenting sutures during closure of a craniotomy in a usual way 
Arm/Interventional Cross–Reference 
 
No dural tenting techniques 
Dural tenting techniques 
Experimental, no dural tenting sutures  
☐ 
 
Active comparator, dural tenting sutures 
 
☐ 
 
9. OUTCOME MEASURES 
 
Outcome 1: 
Primary Outcome Measure: 
Title:  
Reoperation due to epidural hematoma 
Description: 
Percentage 
Time Frame: 
During hospitalization for the surgery, approximately 2 days postoperatively 
Outcome 2: 
Secondary Outcome Measure: 
Title: 
Postoperative 30-day mortality 
Description: 
Percentage 
Time Frame: 
30-day postoperatively 

PG. 7 
 
Outcome 3: 
Secondary Outcome Measure: 
Title: 
Postoperative 30-day readmission to a neurosurgical or neurological department 
Description: 
Percentage 
Time Frame: 
30-day postoperatively 
Outcome 4: 
Secondary Outcome Measure: 
Title: 
New neurologic deficit or deterioration of a previous one 
Description: 
Specific description of a neurologic deficit 
Time Frame: 
During hospitalization, during hospitalisation, as evaluated 5–7 days postoperatively, or earlier if 
the patient is discharged before the fifth postsurgical day. 
Outcome 5: 
Secondary Outcome Measure: 
Title: 
Cerebrospinal fluid leak requiring treatment 
Description: 
Percentage 
Time Frame: 
During hospitalization, during hospitalisation, as evaluated 5–7 days postoperatively, or earlier if 
the patient is discharged before the fifth postsurgical day. 
Outcome 6: 
Secondary Outcome Measure: 
Title: 
Deterioration of postoperative headaches over 5 in Numerical Rating Scale 
Description: 
The Numeric Rating Scale is an 11-point scale for patient self-reporting of pain. It ranges from 0 
(no pain) to 10 (the worst imaginable pain). There are no subscales. Higher values indicate more 
pain and, therefore, represent undesirable outcome. 
Time Frame: 
During hospitalization, during hospitalisation, as evaluated 5–7 days postoperatively, or earlier if 

PG. 8 
 
the patient is discharged before the fifth postsurgical day. 
Outcome 7: 
Secondary Outcome Measure: 
Title: 
Epidural collection thickness over 3 mm measured radiographically 
Description: 
The thickness of the epidural collection measured in a postoperative CT scan  
Time Frame: 
During hospitalization, approximately 1-3 days postoperatively 
Outcome 8: 
Secondary Outcome Measure: 
Title: 
Midline shift over 5 mm 
Description: 
Midline shift caused by the epidural collection measured in a postoperative CT scan  
Time Frame: 
During hospitalization, approximately 1-3 days postoperatively 
 
10. ELIGIBILITY 
 
Sex/Gender: 
Sex: 
All 
Gender–Based:  
No 
Age Limits: 
Minimum Age: 
18 
Unit of Time: 
Years 
Maximum Age: 
75 
Unit of Time: 
Years 
Accepts Healthy Volunteers:  
No 
Eligibility Criteria: 

PG. 9 
 
Inclusion Criteria: 
- 
Male or female over 18 an under 75 years old 
- 
Qualified for an elective supratentorial craniotomy with a diameter of at least 3 cm 
- 
Glasgow Coma Scale 15 preoperatively 
- 
Modified Rankin Scale 0, 1 or 2 preoperatively 
Exclusion Criteria: 
- 
Coagulation abnormalities before the surgery 
- 
Revision craniotomy 
- 
Skull base surgery 
 
11. CONTACTS, LOCATIONS, AND INVESTIGATOR 
INFORMATION 
 
Central Contact Person: 
First Name: 
Przemysław  
Last Name or Official Title: 
Kunert 
Degree: 
MD, PhD 
Phone: 
+48 22 599 25 29  
Email: 
przemyslaw.kunert@wum.edu.pl 
Central Contact Backup: 
First Name: 
Łukasz  
Last Name or Official Title: 
Przepiórka 
Degree: 
Phone: 
+48 22 599 25 75 
Email: 
przepiorka@mp.pl 

PG. 10 
 
Overall Study Official 1: 
First Name: 
Łukasz  
Last Name or Official Title: 
Przepiórka 
Degree: 
Organization/Affiliation: 
Department of Neurosurgery, Medical University of Warsaw 
Official’s Role:  
study principal investigator 
Overall Study Official 2: 
First Name: 
Przemysław 
Last Name or Official Title: 
Kunert 
Degree: 
MD, PhD 
Organization/Affiliation: 
Department of Neurosurgery, Medical University of Warsaw 
Official’s Role:  
study principal investigator 
Facility Information: 
Facility Name: 
Department of Neurosurgery, Medical University of Warsaw 
City: 
Warsaw 
State/Province: 
Mazovian 
ZIP/Postal Code: 
02-097  
Country: 
Poland 
Individual Site Status:  
Recruiting 

PG. 11 
 
Facility contact: 
First Name: 
Łukasz  
Last Name or Official Title: 
Przepiórka 
Degree: 
Phone: 
+48 22 599 25 75 
Email: 
przepiorka@mp.pl 
Facility Contact Backup: 
First name: 
Przemysław 
Last Name: 
Kunert 
Degree: 
MD, PhD 
Phone: 
+48 22 599 25 29 
Email: 
przemyslaw.kunert@wum.edu.pl 
 
 
 Facility Information 
Facility Name: 
Department of Neurosurgery and Oncology of Central Nervous System, Barlicki University Hospital, 
Medical University of Lodz  
City: 
Łódź 
State/Province: 
Łódzkie 
ZIP/Postal Code: 
90-153 
Country: 
Poland 
Individual Site Status:  

PG. 12 
 
Recruiting 
Facility contact: 
First Name: 
Dariusz  
Last Name or Official Title: 
Jaskólski 
Degree: 
MD, PhD 
Phone: 
+48 42 677 67 82 
Email: 
Facility Contact Backup: 
First name: 
Last Name: 
Degree: 
Phone: 
Email: 
 
 
 
Facility Information: 
Facility Name: 
Department of Neurosurgery, Medical University of Silesia, Regional Hospital, Sosnowiec 
City: 
Sosnowiec 
State/Province; 
Śląskie 
ZIP/Postal Code; 
41-200 
Country: 
Poland 

PG. 13 
 
Individual Site Status:  
Recruiting 
Facility contact: 
First Name: 
Piotr  
Last Name or Official Title: 
Ładziński 
Degree: 
MD, PhD 
Phone: 
+48 32 368 25 51 
Email: 
Facility Contact Backup: 
First name: 
Last Name: 
Degree: 
Phone: 
 
Email: 
 
 
 
 
 Facility Information: 
Facility Name: 
Neurosurgery and Pediatric Neurosurgery Department in Lublin, Medical University of Lublin, 
Lublin, Poland 
City: 
Lublin 
State/Province: 
Lubelskie 

PG. 14 
 
ZIP/Postal Code: 
20-954  
Country: 
Poland 
Individual Site Status:  
Recruiting 
Facility contact: 
First Name: 
Radosław 
Last Name or Official Title: 
Rola 
Degree: 
MD, PhD 
Phone: 
+48 81 724 41 76 
Email: 
Facility Contact Backup: 
First name: 
Dariusz 
Last Name: 
Szczepanek 
Degree: 
MD, PhD 
Phone: 
 
Email: 
 
 
 
 Facility Information: 
Facility Name: 
Department of Neurosurgery, 10th Military Research Hospital and Polyclinic, Bydgosz, Poland 
City: 
Bydgoszcz 
State/Province: 

PG. 15 
 
Kuyavian-pomeranian 
ZIP/Postal Code: 
85-681 
Country: 
Poland 
Individual Site Status:  
Recruiting 
Facility contact: 
First Name: 
Kamil 
Last Name or Official Title: 
Krystkiewicz 
Degree: 
MD 
Phone: 
+48 261 417 093 
Email: 
Facility Principal Investigator: 
First name: 
Marek 
Last Name: 
Harat 
Degree: 
MD, PhD 
Phone: 
 
Email: 
 
 
 
 
 
 Facility Information: 
Facility Name: 
Department of Neurosurgery and Pediatric Neurosurgery, Pomeranian Medical University, 
Szczecin, Poland 

PG. 16 
 
City: 
Szczecin 
State/Province: 
West Pomeranian 
ZIP/Postal Code: 
71-252 
Country: 
Poland 
Individual Site Status:  
Recruiting 
Facility contact: 
First Name: 
Leszek 
Last Name or Official Title: 
Sagan 
Degree: 
MD, PhD 
Phone: 
+48 91 425 35 61 
Email: 
Facility Principal Investigator: 
First name: 
Leszek 
Last Name: 
Sagan 
Degree: 
MD, PhD 
Phone: 
 
Email: 
 
 

PG. 17 
 
12. IPD SHARING STATEMENT 
 
Plan to Share IPD: 
No 
IPD Sharing Plan Description 
IPD Sharing Supporting Information Type: 
IPD Sharing Time Frame: 
IPD Sharing Access Criteria: 
IPD Sharing URL: 
 
13. REFERENCES 
 
Citations 
PubMed Identifier: 
12617233 
Citation 
Swayne OB, Horner BM, Dorward NL. The hitch stitch: an obsolete neurosurgical technique? Br J 
Neurosurg. 2002 Dec;16(6):541-4; discussion 544. 
Results Reference: 
No 
PubMed Identifier: 
10433304 
Citation 
Winston KR. Efficacy of dural tenting sutures. J Neurosurg. 1999 Aug;91(2):180-4. 
Results Reference: 
No 
PubMed Identifier: 
9732254 
Citation 

PG. 18 
 
Winston KR. Dural tenting sutures in pediatric neurosurgery. Pediatr Neurosurg. 1998 
May;28(5):230-5. 
Results Reference: 
No 
PubMed Identifier: 
12617233 
Citation 
Swayne OB, Horner BM, Dorward NL. The hitch stitch: an obsolete neurosurgical technique? Br J 
Neurosurg. 2002 Dec;16(6):541-4; discussion 544. 
Results Reference: 
No 
PubMed Identifier: 
Citation 
Wadanamby, S. et al., (2016). Is dural hitching necessary to prevent post-operative extradural 
haemorrhage in craniotomies and craniectomies. Sri Lanka Journal of Surgery. 34(2), pp.11-17. 
DOI: http://doi.org/10.4038/sljs.v34i2.8262 
Results Reference: 
No 
Links 
URL: 
 
Description: 
Available IPD and Supporting Information: 
Available IPD/Information Type: 
Available IPD/Information URL: 
Available IPD/Information Identifier: 
Available IPD/Information Comments: