Groin Surgical Site Infection Incidence in Vascular Surgery With Intradermal Suture Versus Metallic Stapling Skin Closure: A Pragmatic Open-Label Parallel-Group Randomized Clinical Trial
Phase: NA
Conditions: Surgical Site Infection
Sponsor: Hospital Universitari de Bellvitge

 
CLINICAL TRIAL PROTOCOL  
 
 
GROIN SURGICAL SITE INFECTION AFTER INTRADERMAL SUTURE 
CLOSURE VERSUS METALLIC STAPLE CLOSURE: STUDY PROTOCOL OF 
A PRAGMATIC, MULTICENTER, OPEN-LABEL, PARALLEL GROUPS, 
RANDOMIZED CLINICAL TRIAL (VASC-INF) 
 
Sponsor: 
Dr. Ramón Vila i Coll 
Servicio de Angiología y Cirugía Vascular 
Hospital Universitario de Bellvitge 
Carrer de la Feixa Llarga, s/n, 08907-L'Hospitalet de Llobregat, Barcelona. 
Tel.: +34. 93 2607628 
 
Principal Investigator: 
Dra. Elena Iborra Ortega 
Servicio de Angiología y Cirugía Vascular 
Hospital Universitario de Bellvitge 
Carrer de la Feixa Llarga, s/n, 08907-L'Hospitalet de Llobregat, Barcelona. 
Tel.: +34. 93 2607628 
 
Coordinator: 
Dr. Albert González-Sagredo 
Servicio de Angiología y Cirugía Vascular 
Hospital Universitario de Bellvitge 
Carrer de la Feixa Llarga, s/n, 08907-L'Hospitalet de Llobregat, Barcelona 
Tel.: +34. 93 2607221 
 
 
                          PROTOCOL CODE: VASC-INF-2021-01 
 
V5, 21th January 2022 

CLINICAL TRIAL PROTOCOL – VASC-INF v5 
 
  
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                                      SUMMARY 
 
 
VASC-INF TRIAL 
TITLE: GROIN SURGICAL SITE INFECTION AFTER INTRADERMAL SUTURE CLOSURE VERSUS 
METALLIC STAPLE CLOSURE: STUDY PROTOCOL OF A PRAGMATIC, MULTICENTER, OPEN-
LABEL, PARALLEL GROUPS, RANDOMIZED CLINICAL TRIAL (VASC-INF) 
TRIAL REGISTRATION: 
Clinicaltrials.gov: 
NCT05434182 
FUNDING 
This work is supported by B. Braun®. Funding will cover expenses related to clinical 
trial administrative procedures, Institutional Review Board (IRB) and Regulatory 
Authority feed, and services provided by the Contract Research Organization (CRO) 
for study monitoring, pharmacovigilance, e-CRF preparation, statistical analysis, 
and the final report. Costs associated with surgical procedures and the 
complementary tests will be covered by the Catalan Institute of Health and will not 
add additional expenses. Investigators will not receive any financial compensation 
for conducting the study. The corresponding author will have full access to all study 
data and is responsible for submitting the paper for publication. 
 
ROLE OF SPONSOR 
 
The Sponsor will systematically review the study quality management to identify, evaluate 
and control risks to study critical processes and data that would affect patient safety and 
reliability of study data. 

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NAME AND CONTACT INFORMATION FOR THE TRIAL SPONSOR  
 
Dr. Ramon Vila 
Carrer de la Feixa Llarga, s/n, 08907 
rvila@bellvitgehospital.cat 
 
 
 
 
 

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INTRODUCTION 
 
Surgical site infections (SSI) are among the most common and fearsome complications in 
vascular surgery, given its high morbidity and mortality rates1. SSI is associated with a two – to 
three-fold increased risk of death and a 60% increased risk of requiring postoperative intensive 
care support. It increases the length of hospital stay by 7-12 days, patients are five times more 
likely to require readmission, and direct healthcare costs raise at least US$50002–4. SSI is an 
infection that occurs after surgery in the part of the body where the surgery took place5,6. It can 
be superficial, or deep, depending on its characteristics7. The groin is the most common infection 
site in vascular surgery,  because it is a folding area with many lymph glands and is close to 
genitalia8. SSI incidence after vascular surgery has dropped from almost 30%9 in the 1980s to 
20%10 in the 2000s and currently is approximately 10%11. This reduction may be due to 
improvements in asepsis measures and operative time. A 2021 meta-analysis on strategies to 
prevent inguinal SSI reported that using intradermal sutures could associate a lower rate of SSI12. 
One of the papers presents a retrospective SSI incidence analysis among 330 patients who 
underwent arterial vascular intervention through a groin incision. Intradermal suture closure 
was performed in 262 patients, of whom 24 (9.2%) presented SSI, while staples closure was 
conducted in the remaining 68, of whom 17 (25%) developed SSI13. Another paper, published in 
2018, compared the infection rate before (2012-2015) and after (2015-2016) the 
implementation of a dedicated SSI prevention protocol, analyzing among other parameters, the 
inguinal closure technique (i.e., intradermal suture Vs, metallic staples). The results were 
promising, as among the 18 patients with an SSI, 16 (89%) had metallic staples, and only 2 (11%) 
had intradermal sutures, being these results statistically significant14.      
 
 
 
 

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OBJECTIVES 
 
• Our primary objective is to estimate the SSI incidence (superficial and/or deep) 
associated with a femoral approach up to 28 (±2) days after surgery.  
• Our secondary objectives are as follows: 
To estimate the incidence of other surgical wound complications (e.g., seroma, 
hematoma, lymphorrhagia) up to 28 (±2) days after surgery. 
To estimate the incidence of sepsis in patients with SSI up to 28 (±2) days after surgery. 
To describe the timing of prophylactic antibiotic administration. 
To assess the association between nutritional status (measured by serum albumin 
levels) and femoral approach-related SSI up to 28 (±2) days after surgery. 
To assess the association between Body Mass Index (BMI) and femoral approach-
related SSI up to 28 (±2) days after surgery.  
To assess the association between incision length and femoral approach-related SSI 
up to 28 (±2) days after surgery. 
To assess the association between surgery duration and femoral approach-related SSI 
up to 28 (±2) days after surgery. 
To assess the association between the kind of surgery performed and femoral 
approach-related SSI up to 28 (±2) days after surgery. 
To assess the association between length of hospital stay before surgery and femoral 
approach-related SSI up to 28 (±2) days after surgery. 
To assess the association between foot lesions (Rutherford ischemic stages 5 or 6) and 
femoral approach-related SSI up to 28 (±2) days after surgery. 
To estimate the SSI incidence (superficial and/or deep) associated with the femoral 
approach up to 84 (±7) days after surgery.  
 
 
 
 

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DESIGN 
 
• 
STUDY SETTING 
 
We present a pragmatic, multicenter, randomised clinical trial, approved by the Research Ethics 
Committee of the Bellvitge University Hospital (PR047/22) and registered on clinicaltrials.gov 
(NCT05434182). It will be performed in the Bellvitge University Hospital, Germans Trias i Pujol 
University Hospital, and Trieste University Hospital. These are all specialised healthcare centers 
with all the means necessary to carry out complex surgeries. 
 
• 
ELEGIBILITY CRITERIA 
 
All adult patients undergoing revascularisation surgery requiring a femoral approach who meet 
all the inclusion criteria and none of the exclusion criteria will be enrolled in this trial. Patients 
will be informed about the trial and will be invited to participate. All potential participants will 
be notified that the surgical procedure will be conducted per standard clinical practice. We will 
only randomise the type of skin closure (i.e., intradermal sutures or metallic staples).  
 
Patients can be enrolled in the trial if all of the following criteria apply: 
1. Adult patients (≥18 years old) 
2. Both genders 
3. Diagnosed with chronic lower limb ischemia or aortic, iliac, or femoral aneurysm 
4. With a scheduled surgery for one of the following indications: 
a. Femoropopliteal bypass 
b. Femorodistal bypass 
c. Aortobifemoral bypass 
d. Axillofemoral or axillobifemoral bypass 
e. Femorofemoral bypass 
f. Femoral endarterectomy 
g. Femoral approach for exclusion of an aortic aneurysm 
5. Surgical procedure with an incision perpendicular to the groin fold 
6. Patients who undergo both unilateral or bilateral surgical approaches. Note: we will 
consider one patient as one intervention (i.e., bilateral approaches will be quantified as 
one single femoral approach). In the case of bilateral procedures, the closure technique 

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will be the same for both sides.  
7. Patients who sign the written informed consent 
Patients will be automatically excluded if any of the following criteria apply: 
1. Background of a previous surgical intervention in the groin 
2. Femoral approach carried out in a surgical emergency setting 
3. Femoral approach performed due to a femoral pseudoaneurysm 
4. A surgical procedure performed with a transverse/oblique incision to the inguinal fold 
5. A patient who withdraws consent to participate in the trial 
 
• 
RANDOMIZATION, MASKING, DATA COLLECTION AND MONITORING 
 
Participants will be randomly assigned in a 1:1 ratio to intradermal suture (experimental group) 
or metallic staples (control group), using a computer-generated random sequence created with 
R version 4.1.0 (R Foundation for Statistical Computing, Vienna, Austria) for Windows stratified 
by trial site. The randomization sequence was developed by a third-part statistician uninvolved 
with any other aspect of the trial. Patients will be randomized on the day of surgery prior to 
groin closure. The surgical team will remain unaware of the treatment assignment until 
subcutaneous tissue closure, when the nurse will disclose it and inform the team. Given the 
nature of the intervention, neither patients, surgeons, nor investigators will remain blinded to 
treatment allocation once it was undertaken. No masking technique will be performed. Data 
collection will be performed using an ad hoc-created electronic Case Report Form (eCFR) on the 
Research Electronic Data Capture (REDCap®) Platform, which generated an anonymized 
database. Each participant will be assigned a computer-generated code to ensure anonymity. 
Baseline data will include age, sex, body mass index, smoking history, past medical history 
(hypertension, diabetes, dyslipidemia, heart disease, stroke, chronic obstructive pulmonary 
disease, chronic kidney disease, human immunodeficiency virus [HIV]), blood-test results 
(plasma albumin, white blood cell count, hemoglobin, platelets, sodium, potassium, creatinine, 
glomerular filtration rate [GFR]), and surgical indication. For patients with a Rutherford ischemic 
stage 5 or 6, the infection status of any existing ulcer will be also documented based on the 
medical history. Additional data that will be collected include type of surgery, incision length, 
surgeon in charge of skin closure (staff vs. resident surgeon), prosthetic material type, operative 
time, number of days the patient was admitted to the hospital before the day of the surgery, 
and in-hospital stay. Operative time is defined as the time between the incision and the end of 
skin closure. The incision length will be gathered extending the edges of the incision after skin 

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closure.  
 
Data will be securely stored with confidentiality protections in accordance with current local and 
European legislations on personal data protection. Independent monitoring will be performed 
throughout the study to ensure data accuracy, adherence to protocol, and to validate database 
entries against source documents.   
 
• OUTCOMES 
 
Our primary outcome measure is the number (percentage) of patients who present a femoral 
approach SSI up to 28 (±2) days after surgery.  
Our secondary outcome measures are: 
• 
Number (percentage) of patients with other surgical wound complications (e.g., seroma, 
hematoma, lymphorrhagia) up to 28 (±2) days after surgery. 
• 
Number (percentage) of patients who develop sepsis up to 28 (±2) days after surgery. 
• 
Time of prophylactic antibiotic administration. 
• 
Type of microorganisms’ species isolated on the microbiological culture of skin, 
subcutaneous tissue, and/or SSI secretion sample up to 28 (±2) days after surgery. 
• 
Type of antibiotic therapy used in patients with femoral approach-related SSI up to 28 
(±2) days after surgery).  
• 
Serum albumin levels 
• 
BMI 
• 
Surgery duration 
• 
Number of days between hospital admission and surgical intervention 
• 
Number (percentage) of patients who present a femoral approach SSI up to 84 (±7) days 
after surgery. 
• 
Kind of surgery performed 
• 
Presence of foot lesions (Rutherford ischemic stages 5 or 6)  
 
• PARTICIPANT TIMELINE 
 
The entire clinical trial is expected to last approximately 2.5 years. The first patient will be 
included in April 2022, and the last patient is expected to be included in October 2023. 
Afterwards, data collection processes and trial publication is scheduled for October 2024. 

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• PROVISIONS FOR POST-TRIAL CARE 
 
This is a low-level interventional trial since both skin closure techniques are currently used in 
standard clinical care. The complementary diagnostic of follow-up procedures entails the same 
safety risks as those conducted in standard clinical practice. Therefore, ad-hoc insurance has not 
been hired for this trial, given that the participants are already covered by individual or collective 
professional civil liability insurance or equivalent financial guarantee of the healthcare center 
where the clinical trial will be conducted. Likewise, post-trial care will be performed by the 
patient’s designated physician, as per standard clinical practice, following the same follow-up 
protocol that applies to the general population (i.e., that does not participate in the trial). 
 

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INTERVENTION DESCRIPTION: 
 
Once the subjects or their legally authorised representative sign the written informed 
consent, the study will begin. Randomisation will be performed by study team member 
on the day of the surgery, , and only the circulating nurse will know the result. Antibiotic 
prophylaxis will be administered and registered. Groin area hair clipping will be 
performed before entering the operating room (OpR). Then, asepsis of the surgical area 
will be served with 4% chlorhexidine and a steridrape will be placed. The surgical 
intervention will be performed with an incision perpendicular to the inguinal fold. For 
groin closure, the fascia and the subcutaneous tissue will be closed with a continuous 
absorbable filament suture (Vycril [Novosyn® 2/0]). At this moment, the circulating 
nurse will inform about the closure technique (as determined by random assignment). 
Both skin closure techniques are described as follows: 
 
• Metallic stapling: the surgeon everts one of the edges of the skin. Likewise, the 
assistant everts the other edge. The surgeon then staples both skin edges 
together by applying pressure and activating the stapler mechanism. The staples 
should be placed 0.5cm apart and cover the entire incision length. 
• Intradermal suture (Monosyn Braun® 4/0 absorbable monofilament): the 
surgeon chooses one of the wound’s apexes to settle an anchoring dermal stitch. 
Subsequently, performing a mirror image at the opposing side, placing a dermal 
stitch at 0.5cm from the wound edge and always trying to keep the bite at the 
same length. The surgeon then alternates the stitching sides until reaching the 
other apex of the wound, performing five knots to secure the suture. 
Afterwards, passes the needle back deep through the edge, emerging it adjacent 
to the wound, thereby burring the knot.  
 
Once the skin closure has been performed, a surgical dressing will be placed on the groin 
area, thereby finishing the surgery. The surgical dressing will not be uncovered for a 48-
hour timeframe unless strictly necessary. 
 
 
Criteria for Discontinuing or Modifying Allocated Interventions 
Given the characteristics of this clinical trial, once the randomly assigned skin closure 
procedure has been performed, it cannot be modified. Participants may voluntarily 

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discontinue their participation in the clinical trial for any reason, at any time. The 
investigator may also decide at any time during the trial to temporarily interrupt or 
permanently discontinue the patients’ participation in the clinical trial if it is deemed 
that continuation would be detrimental to or not in the participant’s best interest. 
Similarly, the ethics committee or authorised regulatory authority can decide to halt or 
prematurely terminate the trial when new information becomes available whereby the 
rights, safety and well-being of trial participants can no longer be assured, when the 
integrity of the trial has been compromised, or when the scientific value of the trial has 
become obsolete and/or unjustifiable. 

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SCHEDULE OF ASSESSMENTS 
 
1. Baseline visit (Screening and Enrollment): the baseline visit will be primarily 
performed in the Outpatient Clinic. However, if the subject is an inpatient, it will 
be conducted during hospitalisation. A clinical evaluation will assess if the 
subject meets all the inclusion criteria and none of the exclusion criteria. The 
subject will be informed about the trial procedures, as well as about its risks and 
benefits. The Patient Information Sheet (containing complete trial procedures’ 
information) will be handled, and the subject or their legally authorised 
representative will be asked to sign the written informed consent. Once the 
written informed consent has been signed, the subject automatically becomes 
an enrolled study participant. Subsequently, we will gather demographic data, 
BMI, nutritional assessment (i.e., serum albumin levels), past medical history 
and medical examination data. As in standard clinical practice, we will make 
preoperative assessments (chest radiography, electrocardiogram, and blood 
analysis).  
2. Visit 1 (Day of the Surgical Intervention): participants will be randomly assigned 
to one of the study groups right before surgery through the electronic case 
report form (eCRF) itself (Research Electronic Data Capture software [REDCap®] 
platform). After surgery, the study team will record several data: the type of 
anesthesia, any incident during the surgical intervention, the procedures’ 
duration, surgical wound length, the material used (vein, dacron, 
polytetrafluoroethylene, omniflow), closure technique performed and degree of 
the surgeon performing the incision and the closure (a trainee or a staff 
member).  
3. Visit 2 (Hospital Stay): the surgical dressing will be uncovered 48 hours after 
surgery. Patients assigned to the control group (i.e., metallic stapling skin 
closure) will have their staples removed seven days after surgery. Patients 
discharged before the seventh day will have their staples removed in the 
Outpatient Clinic. During the hospital stay, we will perform a daily surgical 
wound inspection. Postoperative blood tests and complications will be 
recorded. This data will be entered into the program on the day of hospital 
discharge. 

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4. Visit 3 (at 28 [±2] days after surgery): a face-to-face visit will be scheduled for 28 
(±2) days after the surgery. The investigator will record (if any) the number and 
reason of extra medical consultation (including Emergency Department, hospital 
readmissions, and primary care either face-to-face or by phone). We will 
perform a surgical wound exam looking for any sign of SSI or other possible local 
complications (e.g., seroma, hematoma, lymphorrhagia). We will record the 
microbiological culture results that could be pending by the time of hospital 
discharge. 
5. Visit 5 (at 84 [±7] days after surgery): It will be a phone interview. The 
investigator will record (if any) the number and reason for extra medical visits 
(including Emergency Department, hospital readmissions, and primary care 
either face-to-face or by phone). We will ask about any symptoms related to 
surgical wound complications, and in case of detecting any alarming signs a face-
to-face visit will be scheduled.  The participant will be informed about the end 
of the study period and perform a standard follow-up protocol. 
 

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Baseline visit 
 
 
Visit 1 
 
Visit 2 
Visit 3: 
28+-3 days 
after 
surgery 
Visit 4: 
84+-7 days 
after 
surgery 
Inclusion of the patient 
Surgical 
intervention 
In-hospital visit 
Inclusion/exclusion criteria 
X 
 
 
 
 
Informed consent 
X 
 
 
 
 
Demographic data  
 
X 
 
 
 
 
Medical history  
X 
 
X 
 
 
Physical exploration  
X 
 
X 
X 
 
Blood test 
X 
 
X 
 
 
Data from surgical intervention  
 
X 
 
 
 
Surgical site infection registry 
 
 
X 
X 
X 
Admissions registry 
 
 
 
X 
X 
 

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ETHICS 
 
This trial will be conducted according to the criteria set by the Declaration of Helsinky, ICH 
Good Clinical Practice standards, and applicable regulations. Patients will be informed that 
their participation in the trial is entirely voluntary and that they can withdraw their consent at 
any time, under no penalty risk whatsoever. The Investigator’s participation in this study is 
free, voluntary, unpaid, and independent. By the current Spanish legislation (Royal Decree 
1090/2015), this clinical trial has a low level of intervention since both skin closure techniques 
are currently used in standard clinical care. The results from this clinical trial are confidential 
and may not be transferred to third parties in any form or manner without written permission 
from the Sponsor. All individuals involved in the clinical trial are bound to this confidentiality 
clause in line with the Regulation (EU) 2016/678 of the European Parliament and of the 
Council of April 27th, 2016, on the protection of natural persons about the processing of 
personal data and on the free movement of such data, as well as other valid and applicable 
laws and regulations, such as the Spanish Organic Law 3/2018, of December 5th, on Personal 
Data Protection and Digital Rights Assurance. When obtaining a signature for the Written 
Informed Consent, the investigator will request written permission from the patient to access 
his/her data directly. With this permission granted, the patient’s data may be examined, 
analysed, verified, and reproduced for the clinical trial evaluation. 
 
Data will be anonymised and dissociated so that the corresponding patient cannot be identified. 
Patients will be assigned consecutive numbers as they are enrolled in the study, and these 
identification numbers (or codes) will be used in the eCRF; the full name of the patient will not 
be included in the eCRFs. The principal investigator of each center will keep an updated patient 
identification list containing the name, clinical history number, and the patient’s identification 
number (or code) for the clinical trial. The study monitor may access the patient’s identity and 
data related to the study monitoring procedures. Anyone with direct access to the data 
(Regulatory Authorities, Trial Monitors, and auditors) will take all possible precautions to 
maintain the confidentiality of patients’ identities. It is the investigator’s responsibility to obtain 
written informed consent from the study patients. The Trial Monitor’s responsibility is to ensure 
that each patient has given their written consent to allow this direct access. The investigator 
shall ensure that the documents provided to the Sponsor do not contain the patient’s name or 
any identifiable data. 

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STATISTICAL METHODS 
 
Our primary endpoint is the number (percentage) of patients who present a femoral approach 
SSI up to 28 (±2) days after surgery. We intend to contrast: 
▪ 
Null hypothesis (Ho): there is no difference in the SSI incidence related 
to the femoral approach between the metallic stapling skin closure and 
the intradermal suture skin closure.  
▪ 
Alternative hypothesis (H1): the SSI incidence related to the femoral 
approach when performing a metallic stapling closure differs from the 
incidence when performing an intradermal suture skin closure. 
 
To our knowledge, no published prospective studies compare SSI incidence between staples and 
intradermal closure. Nonetheless, a 2018 retrospective Finnish study estimated an SSI incidence 
of 9.2% for intradermal suture skin closure and 25.0% for metallic stapling skin closure13. Under 
this assumption, 200 patients (100 per study group) would be necessary to reject the null 
hypothesis at a 5% significance level and a power of 80% using a two-sided 𝒳2 test with a 1:1 
allocation to treatment groups. Accounting a possible dropout rate of 10%, 224 subjects should 
be enrolled (112 per study group). 
 
All analyses related to the intervention efficacy will be based on the intention-to-treat (ITT) 
population, reported according to CONSORT guidelines, basis (as reported in the CONSORT 
guidelines), keeping all patients selected and randomized in the group in which they were 
initially included, regardless of adherence to the protocol. Safety analyses will be based on the 
safety population who have been operated on after randomisation. The demographic and 
clinical profiles of all included subjects will be described by the study group using statistics 
according to variable type.  
 
The primary outcome measure will be compared using the 𝒳2 test. The magnitude of the 
intervention effect will be presented as a cumulative incidence ratio (CIR) at 28 (±2) days after 
surgery, along with a 95% confidence interval (95%CI). In the secondary outcomes, incidences 
will be compared using the 𝒳2 test and the magnitude of the effect will be presented as a CIR 
along with a 95%CI. A regression logistic model will be used to assess the effect of nutritional 
status, BMI, incision length, surgery duration, type of surgery, length of hospital before surgery, 
and femoral approach-related SSI up to 28 (±2) days after surgery.  

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Analysis will be performed using R® version 4.1.0 for Windows® [R Core Team (2020). R: A 
language and environment for statistical computing. R Foundation for Statistical Computing, 
Vienna, Austria. URL: https://www.Rproject.org/]. 
 
 
 
 
 
 
 

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INVESTIGATORS  
 
 
Sponsor 
Dr. Ramón Vila Coll 
Servicio de Angiología y Cirugía Vascular 
 Hospital Universitario de Bellvitge 
Carrer de la Feixa Llarga, s/n, 
08907-L'Hospitalet de Llobregat, Barcelona 
 +34. 93 2607628 
rvila@bellvitgehospital.cat 
Principal 
Investigator 
Dra. Elena Iborra  
Servicio de Angiología y Cirugía Vascular 
Hospital Universitario de Bellvitge 
Carrer de la Feixa Llarga, s/n, 
08907-L'Hospitalet de Llobregat, Barcelona 
+34. 93 2607628 
eiborra@bellvitgehospital.cat 
Coordinator 
Dr. Albert González-Sagredo 
Servicio de Angiología y Cirugía Vascular 
Hospital Universitario de Bellvitge 
Carrer de la Feixa Llarga, s/n, 
08907-L'Hospitalet de Llobregat, Barcelona 
+34. 93 2607221 
albertgonzalezsagredo@gmail.com 
Investigators from 
other hospitals 
  Hospital Germans Trias: Secundino Llagostera Pujol 
Carretera de Canyet s/n, 08916 Badalona 
sllagostera.germanstrias@gencat.cat 
  
Trieste University Hospital:  Mario D’Oria 
Strada di Fiume nº 447, Trieste, Italy  
mario.doria88@outlook.com 

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Ethics 
Committee 
 
Comité de Ética de la Investigación Clínica (CEIC) del Hospital 
Universitario de Bellvitge 
Carrer de la Feixa Llarga, s/n, 
08907-L'Hospitalet de Llobregat, Barcelona 
+34. 93 2607389 
presidenciaCEIC@bellvitgehospital.cat 
Clinical Research 
Unit 
Dr. Sebastián Videla 
Dra. Aurema Otero 
Unidad de Soporte a la Investigación Clínica-[HUB· 
IDIBELL] 
Hospital Universitario de Bellvitge  
Carrer de la Feixa Llarga, s/n, 08907-L'Hospitalet de Llobregat, 
Barcelona  
+34. 93 2607221 ; +34. 93 2602108 
svidela@bellvitgehospital.cat 
Correo electrónico: aoterog@bellvitgehospital.cat 
Contract 
Research 
Organization 
Unidad de Investigación Clínica y de Ensayos Clínicos (UICEC-IDIBELL) 
Hospital Universitario de Bellvitge 
Carrer de la Feixa Llarga, s/n, 
08907-L'Hospitalet de Llobregat, Barcelona 
+34. 93 2607107 
ucicecidibell@bellvitgehospital.cat 
 
 

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