A Randomized Controlled Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using a Tissue Adhesive (Dermabond™) Versus Adhesive Strips (Steri-Strips™) Versus Absorbable Sutures
Phase: NA
Conditions: Laceration
Sponsor: Vanderbilt University Medical Center

 
A randomized controlled trial comparing 
cosmetic outcomes of pediatric laceration 
closure using a tissue adhesive 
(Dermabond™) versus adhesive strips 
(Steri-Strips™) versus absorbable sutures 
 
Study Protocol 
 
NCT ID:  NCT03280628 
 
Document Date:  8/10/2017 
 
Principal Investigator: 
Holly R Hanson, MD, MS 
Vanderbilt University Medical Center 
Pediatric Emergency Medicine 
2200 Children’s Way 
Nashville, TN   37232-9100 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Principal Investigator:  Maureen Saint Georges Chaumet, MD, MS 
Revision Date:  8/10/2017 
Study Title:  A randomized controlled trial comparing cosmetic outcomes of pediatric laceration closure using a tissue 
adhesive (Dermabond™) versus adhesive strips (Steri-Strips™) versus absorbable sutures 
Institution/Hospital: Vanderbilt Children’s Hospital 
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Table of Contents 
Section 
Topic 
Page 
I 
Specific Aim and Study Hypothesis 
3 
II 
Summary of Approach 
3 
III 
Background 
3 
IV 
Rationale 
4 
V 
Inclusion and Exclusion Criteria 
4 
VI 
Subject Recruitment and Enrollment 
4 
VII 
Study Procedures 
5 
VIII 
Predictor Variables 
5 
IX 
Outcome Variables 
6 
X 
Ethical Considerations 
7 
XI 
Risks of Study Participation 
7 
XII 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Subjects or Others 
7 
XIII 
Study Withdrawal or Discontinuation 
7 
XIV 
Data Management 
8 
XV 
Statistical Considerations 
8 
XVI 
Privacy and Confidentiality Issues 
8 
XVII 
Follow-up and Record Retention 
9 
XVIII 
Data Safety and Monitoring Plan 
9 
XIX 
References 
9 

Principal Investigator:  Maureen Saint Georges Chaumet, MD, MS 
Revision Date:  8/10/2017 
Study Title:  A randomized controlled trial comparing cosmetic outcomes of pediatric laceration closure using a tissue 
adhesive (Dermabond™) versus adhesive strips (Steri-Strips™) versus absorbable sutures 
Institution/Hospital: Vanderbilt Children’s Hospital 
- 3 - 
 
I. 
Specific Aim and Study Hypothesis 
Specific Aim: The specific aim of this study is to determine the best of 3 different methods 
of closure of simple pediatric lacerations in terms of cosmetic outcome, pain, need for 
sedation, cost and length of ER stay. 
 
Hypothesis:  We hypothesize that the closure of simple pediatric lacerations with either 
a tissue adhesive (DermabondTM), or adhesive strips (Steri-StripsTM) will provide clinically 
equivalent cosmetic outcomes to absorbable sutures while reducing pain, need for 
sedation, cost and length of ER stay without increasing the risk of complications. 
 
II. 
Summary of Approach  
To address the Specific Aim we will conduct a 3-arm randomized controlled trial comparing 
methods of closure of simple pediatric lacerations. The 3 arms will be: DermabondTM, Steri-
StripsTM, and absorbable sutures (our control arm). 
We will examine the association between closure method and the primary outcome 
variable, cosmesis of the resultant scar. 
As a secondary aim we will assess for statistically significant differences in the degree of 
pain experienced by the patient, in the need for sedation, in the cost of each closure method, and 
in the length of the patient’s ER stay. We anticipate that the treatment arms (DermabondTM, Steri-
StripsTM) will demonstrate no clinically significant difference in cosmetic outcomes while reducing 
the pain experienced by patients during laceration closure, reducing the need for sedation, 
reducing costs and reducing the length of patients’ ER stays. 
 
III. 
Background 
Lacerations are a very common presentation in pediatric Emergency Departments (ED). 
In fact, over the past 2 years (February 2015-2017), there were a total of 3100 lacerations repaired 
in the ED at Monroe Carell Jr’s Children’s Hospital at Vanderbilt (VCH). This can be a painful and 
traumatic procedure for children, especially young children. Given that most lacerations occur in 
young children (74.1% in those less than 6 years old), it is important to use noninvasive and 
painless closure methods when possible.10, 11, 15 
Historically, sutures have been the preferred method of closure for lacerations.18 While 
they have been made of different materials over the years, the general concept of needle and 
string has remained mostly consistent.18 However, new methods of wound closures have been 
developed since. Surgical tape was first developed by surgeon Horace Day in 1845.5 The earliest 
versions of surgical tape had several issues including proper adhesion, skin irritation, blocking of 
perspiration, etc.5 The modern version of surgical tape that we are now familiar with (Steri-
StripsTM) has been around since the 1960s, and except for a few minor modifications, it has largely 
gone unchanged.35 
Tissue adhesives, derived from cyanoacrylate, were invented in the 1940s and have been 
used for decades for wound closure outside of the United States.3 However, it wasn’t until 1998 
that the Food and Drug Administration approved 2-octyl cyanoacrylate (DermabondTM) for use in 
the United States.36 
Despite the availability of both adhesive strips and tissue adhesives, a large study at an 
urban ED showed that while tissue adhesives are more likely to be used in children compared to 
adults, especially in facial lacerations, they are still wildly underused.31 In fact, out of the 3100 
lacerations repaired at VCH, only 108 (3.5%) lacerations were closed using tissue adhesives, and 
none were closed with surgical tape exclusively. This is surprising given that tissue adhesives are 
very versatile (they have even been used to close tongue lacerations and nail bed injuries), and 

Principal Investigator:  Maureen Saint Georges Chaumet, MD, MS 
Revision Date:  8/10/2017 
Study Title:  A randomized controlled trial comparing cosmetic outcomes of pediatric laceration closure using a tissue 
adhesive (Dermabond™) versus adhesive strips (Steri-Strips™) versus absorbable sutures 
Institution/Hospital: Vanderbilt Children’s Hospital 
- 4 - 
 
have good tensile strength.6, 13, 28 Whether the clear preference for traditional sutures is due to a 
lack of knowledge or confidence in alternative methods remains unclear. 
 
IV. 
Rationale 
The aim of this study is to compare different methods of pediatric laceration closure. 
Although Steri-StripsTM and other surgical tapes have been available for decades, there are few 
studies looking at their use in pediatric lacerations.26, 34 Tissue adhesives such as DermabondTM 
have also been largely understudied, though this may be due to the fact that they are a relatively 
newer addition on the market. In fact, a metanalysis in 2008 examining the use of tissue adhesives 
for simple traumatic lacerations found only 11 applicable studies, with only 6 using exclusively 
pediatric patients, only 5 using DermabondTM and some studies not using validated scoring 
systems.1, 7 Most studies have used older versions of tissue adhesives, had small sample sizes 
or were used on iatrogenic lacerations (laparoscopic trocar incisions for example).2, 4, 9, 19, 22, 24, 27, 
29, 30 Two studies compared cosmetic outcomes of scars closed with DermabondTM versus Steri-
StripsTM but neither study used sutures as controls.26, 34 In addition, preliminary studies show that 
tissue adhesives and surgical tape are less costly and may lead to less sedation, which in turn 
can lead to decreased length of stay in the ED.8, 14, 20, 21, 25, 33 The proposed study will provide a 
definitive cosmetic comparison of two alternatives to suturing for pediatric lacerations while 
examining the patient/parent experience in terms of pain, cost and length of ED stay in the hope 
that this will allow for improvement in clinical care.  
 
V. 
Inclusion and Exclusion Criteria 
a. Inclusion criteria 
i. Age 0 to <18 years 
ii. Parents speak English 
iii. Chief complaint of laceration 
iv. Single, linear laceration 
v. Laceration less than 5 cm in length and 0.5 cm in width 
vi. Laceration less than 12 hours old 
vii. Laceration minimally contaminated (no visible dirt in wound) 
b. Exclusion criteria 
i. Significant medical history that may impact wound healing (hematologic or 
oncologic diagnosis requiring chemotherapy, ichthyosis, epidermolysis 
bullosa, etc.) 
ii. Use of oral steroids (more than 5 days in the past month) 
iii. History of keloid formation 
iv. Allergy to tissue adhesives, adhesive strips, or topical anesthetics 
v. Lacerations requiring deep sutures 
vi. Lacerations caused by animal bites or scratches 
vii. Lacerations located on the scalp, eyebrow, eyelid, lip, mucosa, joint or nail 
bed 
viii. No access to photographic capabilities (camera or smartphone) and/or e-
mail, or unable to return to the VCH ED to have a picture taken 
VI. 
Subject Recruitment and Enrollment 
We will enroll a sample of 90 children and adolescents 0 to <18 years of age. All eligible 
patients will be recorded in the Screening Log (see Appendix I).  

Principal Investigator:  Maureen Saint Georges Chaumet, MD, MS 
Revision Date:  8/10/2017 
Study Title:  A randomized controlled trial comparing cosmetic outcomes of pediatric laceration closure using a tissue 
adhesive (Dermabond™) versus adhesive strips (Steri-Strips™) versus absorbable sutures 
Institution/Hospital: Vanderbilt Children’s Hospital 
- 5 - 
 
Subject identification and enrollment will be performed by trained study staff stationed in 
the VCH ED. The study staff enrolling the patient will obtain written informed consent and/or 
assent, as applicable (see Consent Form and Assent Forms). Study staff will also complete a 
Subject Enrollment Form (see Appendix II) and Subject Data Form (see Appendix III) which will 
be maintained in a locked file in the ED. 
 
VII. 
Study Procedures 
Study Design 
The study design will be a single-blind, randomized controlled trial. After enrollment, all 
participants will have LET placed and their wound washed out with sterile normal saline.  
Depending on which arm they are randomized to, participants will have their laceration 
closed by either DermabondTM, Steri-StripsTM, or absorbable sutures per the treatment arm 
protocols (Protocols, see Appendix IV). Unfortunately, given the nature of the study, neither the 
patient, parent nor health care provider will be blinded to the method of closure. Additional topical 
or injected anesthetics or the use of sedation will be left up to the patient/parent and provider’s 
discretion. After the procedure, both patient (if older than 3 years old) and parent/guardian will be 
asked to fill out a short questionnaire (Questionnaires, see Appendix VI). The parent/guardian will 
be asked to rate the appearance of 3 images of random scars. All parents/guardians in the study 
will rate the same 3 scars to establish a baseline for each parent. The health care provider will 
also be asked to fill out a short questionnaire (Questionnaires, see Appendix VI). Upon discharge, 
the participant and their parent/guardian will be provided with verbal and written return 
precautions by the study staff (Care Instructions, see Appendix V). 
Parents/guardians will be called 3 months after their initial visit for a brief over-the-phone 
interview (Questionnaires, see Appendix VI). At this time, they will be prompted to take a picture 
of the scar and send it to the Investigator by e-mail. A Vanderbilt email address has been set-up 
and is secure per Vanderbilt criteria. As an alternative, they can come back to the VCH ED where 
study staff will ask them a couple of questions in person and take a picture of the scar. 
Every effort will be made to de-identify the images of the scar (using image editing 
software to crop everything on the image but the scar with some surrounding skin). The images 
will then be collected and presented to two Plastic Surgeons who will be blinded to the method of 
closure. They will subsequently score the scar as seen in the images (Questionnaires, see 
Appendix VI). All data will be collected on paper and then transferred to REDCap. Each piece 
of data will be transferred to REDCap by two study staff independently and then examined for 
any differences which can be reconciled by examining the paper forms. This will prevent errors in 
transferring data from paper to electronic format. 
Participants will be compensated with a $15 check after completion of the 3 month 
questionnaire and sending of photo. 
 
Randomization 
Randomization will be accomplished using randomizer.org software to generate a set of 
90 numbers from 1 to 3 for 90 enrolled participants. Each digit from 1 to 3 will correspond to a 
study arm. 
 
Data Acquisition 
Study data will be acquired through the means of the aforementioned questionnaires 
(Questionnaires, see Appendix VI), phone interviews, and by simple chart review. The secondary 
outcome of “cost of visit” will be acquired through Medical Records. 
 

Principal Investigator:  Maureen Saint Georges Chaumet, MD, MS 
Revision Date:  8/10/2017 
Study Title:  A randomized controlled trial comparing cosmetic outcomes of pediatric laceration closure using a tissue 
adhesive (Dermabond™) versus adhesive strips (Steri-Strips™) versus absorbable sutures 
Institution/Hospital: Vanderbilt Children’s Hospital 
- 6 - 
 
VIII. 
Predictor Variables 
Predictor variables are the 3 treatment allocation arms: DermabondTM, Steri-StripsTM, and 
absorbable sutures. Other independent variables to be collected include demographics of the 
patient (age, sex, race/ethnicity), specifics of the laceration (location, length and width, time 
between trauma and wound closure) and level of training of the provider who will be closing the 
wound. Demographics will be extracted from the patient Electronic Medical Record and from the 
parent Questionnaire (Questionnaires, see Appendix VI). Both the specifics of the laceration and 
the level of training of the provider will be extracted from the provider questionnaire at the time of 
the procedure (Questionnaires, see Appendix VI).  
 
IX. 
Outcome Variables 
a. Primary outcome variable 
The primary outcome will be cosmesis of the resultant scar as measured on a 100 mm Visual 
Analogue Scale where a score of 0 corresponds to “worst scar” and a score of 100 corresponds 
to “best scar.” This scale has been validated as a scoring method to evaluate cosmesis of a 
scar.12, 16, 17, 23, 32 Due to its sensitivity and the fact that it provides parametric data, the scale allows 
for smaller, more practical sample sizes to show clinically-significant differences in populations.12, 
16, 17, 23, 32 The Visual Analogue Scale will be used by two Plastic Surgeons blinded to closure 
method to rate a patient’s scar at 3 months. In addition, parents will be asked to rate the scar on 
a scale of 0 to 100 during their over-the-phone interview at 3 months. We will compare their rating 
of their child’s scar to the average of their ratings of the 3 images of random scars at the initial 
visit.  
b. Secondary outcome variables 
i. Pain experienced by patient 
This secondary outcome will be evaluated by the patient (if age-
appropriate), parent and provider at the time of the ER visit 
(Questionnaires, see Appendix VI). Patients aged 3 to 12 will be asked to 
rate their pain on a Wong-Baker FACES® Pain Rating Scale (licensing for 
use in progress). Patients aged 12 to 18 will be asked to rate their pain 
using a 100 mm Visual Analogue Scale with a score of 0 corresponding to 
“No pain” and a score of 100 corresponding to “Terrible pain.” Parents and 
providers will each be asked to score how much pain they felt the patient 
experienced on the same Visual Analogue Scale. 
ii. Need for anesthetics/anxiolytics/sedation 
This secondary outcome examines the need for adjuncts to control 
pain/anxiety including LET, injected lidocaine, anxiolytics or systemic pain 
medications, ketamine sedation or others. Data will be collected by study 
staff observing the procedure. Data will also be extracted from the patient’s 
Electronic Medical Record. 
iii. Length of procedure 
This secondary outcome, measured in minutes, will be collected by study 
staff observing the procedure. 
iv. Cost of visit 
This data will be extracted from the patient’s Electronic Medical Records 
and from the Billing Department. 
v. Length of ER stay 
This data will be extracted from the patient’s Electronic Medical Records. 
vi. Resource utilization 

Principal Investigator:  Maureen Saint Georges Chaumet, MD, MS 
Revision Date:  8/10/2017 
Study Title:  A randomized controlled trial comparing cosmetic outcomes of pediatric laceration closure using a tissue 
adhesive (Dermabond™) versus adhesive strips (Steri-Strips™) versus absorbable sutures 
Institution/Hospital: Vanderbilt Children’s Hospital 
- 7 - 
 
This secondary outcome examines the need for personnel in the room to 
keep the child calm or still. This data will be collected by study staff 
observing the procedure. 
vii. Likelihood that parent would recommend wound closure type 
This secondary outcome will be measured using a 100 mm Visual 
Analogue Scale with a score of 0 corresponding to “Extremely unlikely” and 
a score of 100 corresponding to “Extremely likely.” This data will be 
extracted from the parent questionnaire at the time of the ED visit 
(Questionnaires, see Appendix VI). 
viii. Complications 
Prevalence of complications (infection, dehiscence, etc.) will be evaluated. 
This secondary outcome will be obtained during the brief phone 
questionnaire with parents at 3 months after the ED visit (Questionnaires, 
see Appendix VI). 
ix. Poor cosmetic outcome 
This secondary outcome will be extracted from the Visual Analogue Scales 
used to rate a patient’s scar, as evaluated by both the parent and Plastic 
Surgeons blinded to method of closure (Questionnaires, see Appendix VI). 
A score less than 35 mm on the 100 mm scale will be considered “poor 
cosmetic outcome” as used in previous studies. 
x. Presence of train tracks 
This secondary outcome will be extracted from the Plastic Surgeon 
questionnaire at 3 months (Questionnaires, see Appendix VI). 
 
X. 
Ethical Considerations 
DermabondTM and Steri-StripsTM are both FDA-approved methods of laceration closure 
and there have been no studies demonstrating the inferiority of these closure methods compared 
to sutures, the traditional method of laceration closure. Thus, randomizing patients to either 
DermabondTM or Steri-StripsTM treatment arms does not violate the principle of equipoise. 
 
XI. 
Risks of Study Participation 
Surveillance for medical risks, including but not limited to infection and dehiscence, will be 
performed during the study of each subject by Dr. Maureen Saint Georges Chaumet. 
The specific aim of this study involves the collection of Personal Health Information (PHI). 
HIPAA regulations pertaining to subjects’ PHI will be reviewed with the Vanderbilt IRB and 
assurance of conformity to these regulations and protection of PHI provided. As noted, we are 
taking steps to protect this information. Study staff are required to honor and preserve patient 
confidentiality and privacy at all times and in all management of data and data files. All completed 
subject information forms will be initially placed in a locked box in the VCH ED after enrollment 
and data collection. Forms will then be promptly transferred to individual patient files and 
maintained in a locked data collection box in a locked office in order to maintain confidentiality 
and security of data. Photos will be e-mailed to a secure Vanderbilt e-mail. Access to computer 
files will be further restricted by file passwords. The database will be maintained on REDCap. 
 

Principal Investigator:  Maureen Saint Georges Chaumet, MD, MS 
Revision Date:  8/10/2017 
Study Title:  A randomized controlled trial comparing cosmetic outcomes of pediatric laceration closure using a tissue 
adhesive (Dermabond™) versus adhesive strips (Steri-Strips™) versus absorbable sutures 
Institution/Hospital: Vanderbilt Children’s Hospital 
- 8 - 
 
XII. 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Subjects or Others 
Any unexpected problems involving risks to subjects or others will be immediately reported 
to the Institutional Review Board of Vanderbilt University within ten days using the IRB form 
#1105. 
 
XIII. 
Study Withdrawal or Discontinuation 
Patients and their parent/guardian(s) will be told very explicitly by the investigators that 
their participation in this research investigation is entirely voluntary and that they may withdraw at 
any time. We will further emphasize verbally and in the informed consent document that a decision 
on the part of the patient or parent/guardian(s) to not participate will in no way change, 
compromise or jeopardize the patient’s care. Indeed, we anticipate that a number of eligible 
patients will not be enrolled on this basis.  
 
XIV. 
Data Management 
Participants’ information (Subject Enrollment Form, see Appendix II, Questionnaires, see 
Appendix VI, pictures) will be kept in a separate file for each subject. Data will be transferred to 
the REDCap server. This data will then be sent for statistical analysis. 
 
XV. 
Statistical Considerations 
We are planning a study of a continuous response variable from independent control 
and experimental subjects with 1 control per experimental subject. In previous studies, the 
response within each subject group was normally distributed with a standard deviation of 15 mm 
on a 100 mm Visual Analogue Scale and the minimal clinically important difference between two 
scars was 15 mm on a 100 mm Visual Analogue Scale.16, 17, 32 We performed multiple sample 
size power calculations using STATA 14.1 (College Station, Texas). Using one-way ANOVA, 
with a power of 90% and an alpha of 0.05, we would need between 5 and 21 subjects per group 
to detect a clinically significant difference of 5 to 15 mm between groups depending on the 
standard deviation in each group (in anticipation of the fact that we may have a larger standard 
deviation). In order to assure an effective sample size after accounting for dropouts and missing 
data, we propose to recruit 30 experimental subject per treatment arm and 30 control subjects, 
for a total of 90 subjects. 
  
XVI. 
Privacy and Confidentiality Issues 
After the parents have signed the consent form, and the patient has signed the assent 
form as applicable, one copy will be given to the parents and one copy will be kept by Dr. Maureen 
Saint Georges Chaumet in a locked data collection box in a locked office. All efforts, within reason, 
will be made to keep protected health information (PHI) private. PHI is health information that is 
or has been gathered or kept by Vanderbilt as a result of a subject’s healthcare. This includes 
data gathered for research studies, and can be traced back to the subject. Using or sharing 
(“disclosure”) such data must follow federal privacy rules. By signing the consent for this study, 
subjects are agreeing (“authorization”) to the uses and possible sharing of PHI. If a patient or their 
parent/guardian decides to be in this research study, he/she is also agreeing to let the study team 
use and share PHI as described below.  
As part of the study, Dr. Maureen Saint Georges Chaumet and her study team may share 
the results of a subjects’ study-linked questionnaires and photos, as well as parts of the medical 

Principal Investigator:  Maureen Saint Georges Chaumet, MD, MS 
Revision Date:  8/10/2017 
Study Title:  A randomized controlled trial comparing cosmetic outcomes of pediatric laceration closure using a tissue 
adhesive (Dermabond™) versus adhesive strips (Steri-Strips™) versus absorbable sutures 
Institution/Hospital: Vanderbilt Children’s Hospital 
- 9 - 
 
record, to the groups named below. These groups may include people from the Federal 
Government Office for Human Research Protections, the Vanderbilt University Institutional 
Review Board, and insurance companies for billing purposes.  Federal privacy rules may not 
apply to these groups; they have their own rules and codes to assure that all efforts, within reason, 
will be made to keep PHI private.  
Dr. Maureen Saint Georges Chaumet may give health data, without a subject’s name, to 
others or use it for other research projects. Vanderbilt and Dr. Maureen Saint Georges Chaumet 
and her staff will keep each subject’s PHI in strict confidence, and will comply with any and all 
laws regarding the privacy of such information. 
 
XVII. 
Follow-up and Record Retention 
Research data will not be kept in a subject’s medical record. Deidentified study results will 
be kept for up to 5 years after the study is finished but all identifying data will be destroyed once 
the study is finished. 
 
XVIII. 
Data Safety and Monitoring Plan 
Surveillance for medical risks, including but not limited to infection and dehiscence, will be 
performed during the study of each subject by the study investigators. Any adverse events will be 
reported as per IRB guidelines.   
Electronic data have several levels of protection. Any file that may contain patient 
identifiers will be password protected.  All computers upon which data are stored are likewise 
password protected and are running anti-virus programs that automatically update definitions. All 
data are automatically backed-up to a secondary hard drive on a nightly basis. Access to the 
Vanderbilt computer network is protected at the level of firewalls, TCP wrappers and university-
assigned user IDs. Data are secured with encryption algorithms and the network is maintained by 
the Medical Center’s Network Computer Services. 
 
XIX. 
References  
(1) 
Beam, JW. “Tissue adhesives for simple traumatic lacerations.” J Athl Train 43.2 (2008): 
222-4. 
(2) 
Bruns, T et al. “Laceration repair using a tissue adhesive in a children's emergency 
department.” Pediatrics 98.4.1 (1996): 673-5. 
(3) 
Bruns, T and JM Worthington. “Using tissue adhesive for wound repair: A practical guide to 
Dermabond.” Am Fam Physician 61.5 (2000): 1383-1388. 
(4) 
Devrukhkar, VN et al. “Evaluation of isoamyl 2-cyanoacrylate tissue adhesive in 
management of pediatric lacerations: An alternative to suturing.” Ann Maxillofac Surg 5.1 
(2015): 49-54. 
(5) 
Edelman, J. “A brief history of tape.” Ambidextrous 5 (2006): 45-46. 
(6) 
Edwards, S and L Parkinson. “Is Fixing Pediatric Nail Bed Injuries With Medical Adhesives 
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(7) 
Farion, KJ et al. “Tissue adhesives for traumatic lacerations: a systematic review of 
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(8) 
Harman, S et al. “Efficacy of pain control with topical lidocaine-epinephrine-tetracaine during 
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185.13 (2013): 629-34. 
(9) 
Hasan, Z et al. “Sutureless skin closure with isoamyl 2-cyanoacrylate in pediatric day-care 
surgery.” Pediatr Surg Int 25.12 (2009): 1123-5. 

Principal Investigator:  Maureen Saint Georges Chaumet, MD, MS 
Revision Date:  8/10/2017 
Study Title:  A randomized controlled trial comparing cosmetic outcomes of pediatric laceration closure using a tissue 
adhesive (Dermabond™) versus adhesive strips (Steri-Strips™) versus absorbable sutures 
Institution/Hospital: Vanderbilt Children’s Hospital 
- 10 - 
 
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(27) Saxena, AK and GH Willital. “Octylcyanoacrylate tissue adhesive in the repair of pediatric 
extremity lacerations.” Am Surg 65.5 (1999): 470-2. 
(28) Shapiro, AJ et al. “Tensile strength of wound closure with cyanoacrylate glue.” Am Surg 
67.11(2001): 1113-5. 
(29) Simon, HK et al. “Lacerations against Langer's lines: to glue or suture?” J Emerg Med 16.2 
(1998): 185-9. 
(30) Simon, HK et al. “Long-term appearance of lacerations repaired using a tissue adhesive.” 
Pediatrics 99.2 (1997): 193-5. 
(31) Singer, AJ et al. “Patterns of use of topical skin adhesives in the emergency department.” J 
Acad Emerg Med 17.6 (2010): 670-2. 
(32) Tejani, C et al. “A comparison of cosmetic outcomes of lacerations on the extremities and 
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43. 

Principal Investigator:  Maureen Saint Georges Chaumet, MD, MS 
Revision Date:  8/10/2017 
Study Title:  A randomized controlled trial comparing cosmetic outcomes of pediatric laceration closure using a tissue 
adhesive (Dermabond™) versus adhesive strips (Steri-Strips™) versus absorbable sutures 
Institution/Hospital: Vanderbilt Children’s Hospital 
- 11 - 
 
(33) Zempsky, WT et al. “Economic comparison of methods of wound closure: wound closure 
strips vs. sutures and wound adhesives.” Int Wound J 2.3 (2005): 272-81. 
(34) Zempsky, WT et al. “Randomized controlled comparison of cosmetic outcomes of simple 
facial lacerations closed with Steri Strip Skin Closures or Dermabond tissue adhesive.” J 
Pediatr Emerg Care 20.8 (2004): 519-24. 
(35) History of 3M Medical Tapes. Available at 
http://solutions.3mae.ae/wps/portal/3M/en_AE/Medical_Tapes_EU/home/history/. 
Accessed: June 21, 2017. 
(36) US Food and Drug Administration. FDA Dermabond Approval Order. Available at 
http://www.accessdata.fda.gov/cdrh_docs/pdf/P960052b.pdf. Accessed: June 21, 2017.