Interrupted Subdermal Suture Spacing During Linear Wound Closures and the Effect on Wound Cosmesis: a Randomized Evaluator Blinded Split Wound Comparative Effectiveness Trial
Phase: NA
Conditions: Interrupted Subdermal Suture
Sponsor: University of California, Davis

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
Version Date: 5/6/2014 
Page 1 of 16 
Revised: November 27, 2013  
 
 
NCT03327922 
Interrupted subdermal suture spacing during 
linear wound closures and the effect on wound 
cosmesis: a randomized evaluator blinded split 
wound comparative effectiveness trial 
Date: December 14, 2017 
 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
Version Date: 5/6/2014 
Page 2 of 16 
Revised: November 27, 2013  
 
1) 
Protocol Title 
Interrupted subdermal suture spacing during linear wound closures and the effect on 
wound cosmesis: a randomized evaluator blinded split wound comparative 
effectiveness trial   
2) 
Author of Protocol 
 
X  UC Davis Researcher 
p Researcher from other institution 
p Private Sponsor 
p Cooperative Group 
p Other: _________________ 
 
3) 
IRB Review History 
N/A 
4) 
Objectives 
The purpose of this study is to determine whether the spacing between 
subdermal interrupted sutures during repair of linear cutaneous surgery 
wounds on the trunk or extremities affects scar cosmesis.  We will use a 
split wound model, where half of the wound is repaired with sutures 
spaced two centimeters apart and the other half is repaired with sutures 
spaced one centimeter apart. Three-months post-surgery, the scar will be 
measured via the patient observer scar assessment scale, a validated scar 
instrument.  The scar width, and adverse events will also be recorded. 
5) 
Background 
Sutures are the standard of care in repairing cutaneous wounds. The 
majority of surgical reconstructions following a Mohs micrographic 
surgery and standard surgical excisions require two layers of sutures: a 
deep layer and a top layer. The deep layer dissolves naturally whereas the 
top layer must be removed.   
 
This study aims to investigate whether the spacing of the interrupted deep 
(subdermal) sutures affects surgical wound cosmesis on the trunk and 
extremities. In other words, we would like to determine which of the 
following yields a more cosmetically appealing scar: many closely 
approximated subdermal sutures or fewer, more widely spaced subdermal 
sutures.  We wish to compare the effects of one versus two centimeter 
spacing between sutures. It is possible that fewer, more widely spaced 
sutures may leave more open space in the wound, leaving more tension to 
pull on those few sutures, possibly encouraging the wound to dehisce and 
make it harder to approximate the wound edges yielding a less 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
Version Date: 5/6/2014 
Page 3 of 16 
Revised: November 27, 2013  
cosmetically appealing scar compared to placing many closely 
approximated sutures which would decrease the tension and likely better 
approximate the wound edges yielding a more cosmetically appealing 
scar.  On the other hand, we may find that suture spacing has no effect on 
wound cosmesis and that placing fewer, more widely spaced sutures is 
much more time efficient. We may also find that the effect of suture 
spacing on wound cosmesis is dependent on wound tension. For example, 
perhaps the suture pacing would have no effect on the cosmesis of a 
wound under no tension, however, for a wound under high tension, it is 
possible that many closely approximated sutures would yield better 
cosmetic results for the reasons listed above.   
 
After completing a thorough literature search, there appears to be no data, 
recommendations, or studies published on the affect of subdermal suture 
spacing on wound cosmesis.   
 
6) 
Inclusion and Exclusion Criteria 
Describe how your individuals will be screened for eligibility. 
All patients scheduled for cutaneous surgical procedures with one of the 
study investigators at the UC Davis Dermatology Clinic will be screened 
for eligibility. 
Describe the criteria that define who will be included or excluded in your 
final study sample. 
Inclusion Criteria: 
• 18 years of age or older 
• Able to give informed consent themselves  
• Patient scheduled for cutaneous surgical procedure on the trunk 
and extremities with predicted primary closure 
• Willing to return for follow up visit. 
Exclusion Criteria: 
• Mentally handicapped 
• Unable to understand written and oral English  
• Incarceration 
• Under 18 years of age 
• Pregnant Women 
• Wounds with predicted closure length less than 4 cm  

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
Version Date: 5/6/2014 
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Revised: November 27, 2013  
Indicate specifically whether you will include or exclude each of the 
following special populations: (You may not include members of the above 
populations as subjects in your research unless you indicate this in your 
inclusion criteria.) 
• Adults unable to consent 
• Individuals who are not yet adults (infants, children, teenagers) 
• Pregnant women 
• Prisoners 
None of these special populations will be included 
7) 
Number of Subjects 
a) Study- Wide: 
This is a single center study; see below. 
b) Local: 
Indicate the total number of subjects to be enrolled locally. 
We will enroll 50 patients locally in this single center study. 
 
8) 
Recruitment Methods 
a) Study-Wide: 
NA 
Describe when, where, and how potential subjects will be recruited. 
Patients will be recruited from the investigators surgical practice at the 
time of the procedure at the University of California, Dermatology Clinic 
Describe the methods that will be used to identify potential subjects. 
The surgical schedule will be examined to identify potential study 
subjects. Faculty will be reminded about the study through a flier posted in 
the doctors charting lounges (Attached). 
Describe materials that will be used to recruit subjects. (Attach copies of 
these documents with the application. For advertisements, attach the final 
copy of printed advertisements. When advertisements are taped for 
broadcast, attach the final audio/video tape. You may submit the wording 
of the advertisement prior to taping to preclude re-taping because of 
inappropriate wording, provided the IRB reviews the final audio/video 
tape.) 
b) HIPAA: 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
Version Date: 5/6/2014 
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Revised: November 27, 2013  
If the research procedures include accessing personal health information 
(PHI) to identify prospective subjects without HIPAA Authorization please 
describe:  
• Why getting HIPAA Authorization is not practicable.  
• Why the research can’t be conducted without access to this PHI.  
• Your plan to protect the PHI from improper use and disclosure, 
including the plan to destroy the PHI at the earliest opportunity.  
• Assurance that the protected health information will not be 
inappropriately reused or disclosed to any other person or entity. 
• Description of the protected health information which will be 
accessed 
The patients name, age, gender, medical record number, operative and 
follow up images and phone number will be recorded in the Redcap 
data system to allow study personnel to contact patients to arrange 
their follow up visits. Information will be deleted from the redcap 
system after 3 years. HIPPA authorization will be obtained from each 
patient. 
 
9) 
Compensation to the Subjects 
 
If the subjects will be compensated for their participation within the study 
describe the amount and type of compensation that will be paid to subjects. 
Clarify how compensation will be pro-rated if the subjects does not 
complete all study visits. 
No compensation provided to study subjects. 
 
10) Study Timelines 
Describe: 
• The duration of an individual subject’s participation in the study. 
3 months 
• The duration anticipated to enroll all study subjects. 
3 months 
• The estimated date for the investigators to complete this study 
(complete primary analyses) 
12 months 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
Version Date: 5/6/2014 
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Revised: November 27, 2013  
11) Study Endpoints 
Describe the primary and secondary study endpoints. 
The primary endpoint will be the score of two blinded reviewers using the 
patient observer scar assessment score at a three-month assessment visit.  
The secondary endpoints will include the width of the scar 1 cm from 
midline on each side at the follow-up visit and any complications from the 
treatment. 
 
Describe any primary or secondary safety endpoints. 
Cutaneous surgery is a very low risk procedure. No deaths have ever been 
observed in our department, minor infections occur at rates of < 3% and 
bleeding and dehiscence at much lower rates still. All adverse events will 
be recorded, and monitored. Serious adverse events will be reported, 
though none are expected. 
12) Procedures Involved 
a) Describe and explain the study design. 
This is a single center, randomized, evaluator blind, split wound study.  
 
Provide a description of all research procedures being performed and 
when they are performed, including procedures being performed to 
monitor subjects for safety or minimize risks. 
 
After screening and informed consent, demographic data will be collected 
including date of birth, race, gender and medical record number.  This will 
be collected in the redcap database.  
The patient’s wound will be labeled A if it is on the left or superior side of 
the investigator and B if it is on the right or inferior side. A predetermined, 
concealed randomization number will be obtained from the RedCap 
randomization module, which will specify how side A is to be treated. 
Side B will be treated the opposite way as A. Side A will always be closed 
first. The side assigned to be closed with sutures spaced two centimeters 
apart will be treated in a simple, interrupted subdermal pattern. Sutures 
spaced one centimeter apart will be used to treat the opposite side in a 
simple, interrupted subdermal pattern. After placement of the deep 
stitches, both sides of the wound will be sewn together with a top layer of 
stitches, as is the standard of care. A digital image of the wound before 
and after the top stitches are placed will be obtained; these may be used in 
scientific talks and/or for publication purposes. Treatment assignment, 
wound length, demographic data, and digital images will be recorded 
within the redcap database. 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
Version Date: 5/6/2014 
Page 7 of 16 
Revised: November 27, 2013  
Follow-up assessment will be scheduled for three months following the 
procedure, with a one-month window before or after that time if the 
patient cannot return at precisely three months. 
At the follow-up visit, two blinded observers will record their scores 
independently using the physician observer scar assessment score 
instrument (POSAS). The width of the scar on both sides will also be 
measured and recorded 1 cm from midline on both sides of the scar. If one 
half of the scar has more associated erythema, that will be recorded. The 
patient part of the instrument will be independently recorded. This data 
will be recorded in the redcap database. Digital images will then be 
obtained again, which may be used for scientific meeting presentation 
and/or publication purposes. 
 
Describe: 
• Procedures performed to lessen the probability or magnitude of risks. 
All adverse events will be monitored and recorded. Safety precautions will 
be the same as for all patients undergoing cutaneous procedures. Patients 
will be given instructions to call in the event of any complications such as 
bleeding, infection, pain or any concerns. An on call resident will be 
available by phone at all hours, every day of the week. Instructions for 
contacting the on call resident will be given in written form as well. 
• All drugs and devices used in the research and the purpose of their 
use, and their regulatory approval status. 
The type of suture device used on the deep portion of the wound will be at 
the discretion of the investigator. The type used will be either vicryl, 
monocryl, or  PDS as these are all standard of care.  
• The source records that will be used to collect data about subjects. 
(Attach all surveys, scripts, and data collection forms.) 
We will collect all data, demographic and scientific, in the redcap data 
collection system. The patient will be queried for demographic data 
verbally or the patient chart will be examined within the EMR to obtain 
the date of birth, race, gender, date of surgery, date of follow-up, name, 
medical record number, and surgery location. All other data will be 
recorded from assessments during study evaluation.  
• What data will be collected including long-term follow-up. 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
Version Date: 5/6/2014 
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Revised: November 27, 2013  
POSAS scores, width of the scar 1 cm from midline on each side, digital 
images, occurrence of any complications including: spitting sutures, 
dehiscence, infection, necrosis, bleeding, and hematoma. 
• Describe how much blood is being drawn and how often 
NA 
b) Humanitarian Use Device (HUD) 
For HUD uses provide a description of the device, a summary of how you 
propose to use the device, including a description of any screening 
procedures, the HUD procedure, and any patient follow-up visits, tests or 
procedures. 
NA 
13) Data and Specimen Banking 
If data or specimens will be banked for future use, describe where the 
specimens will be stored, how long they will be stored, how the specimens 
will be accessed, and who will have access to the specimens. 
NA 
List the data to be stored or associated with each specimen. 
NA 
Describe the procedures to release data or specimens, including: the 
process to request a release, approvals required for release, who can 
obtain data or specimens, and the data to be provided with specimens. 
NA 
14) Data Management and Confidentiality 
Describe the data analysis plan, including any statistical procedures. 
Paired t-test will be performed for POSAS scores and scar width. For 
analysis of complications Fisher’s exact test will be used. 
Provide a power analysis. 
Using g*power statistical software, we calculated we would need to enroll 
50 patients using a split scar model with a mean POSAS score of 12 a 
minimal meaningful clinical difference of 3 points on the 60 point POSAS 
scale with the following assumptions: alpha 0.05, beta 0.10, standard 
deviation 6 (based upon wound eversion study results from trial completed 
by us last year), dropout rate 15%. 
Describe the steps that will be taken secure the data (e.g., training, 
authorization of access, password protection, encryption, physical 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
Version Date: 5/6/2014 
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Revised: November 27, 2013  
controls, certificates of confidentiality, and separation of identifiers and 
data) during storage, use, and transmission. 
Redcap database will be used to record all data. It is maintained by the 
University of California, Davis and encrypted. Passwords for access will 
not be shared. For analysis, data will only be downloaded without personal 
identifiers. 
Describe any procedures that will be used for quality control of collected 
data. 
Questions in the data collection forms will have warning text that will 
appear if users attempt to close them without recording the required data. 
a.) Study-Wide: 
Describe how data and specimens will be handled study-wide: 
NA. Study is single center only. 
• What information will be included in that data or associated with the 
specimens? 
• Where and how data or specimens will be stored? 
• How long the data or specimens will be stored? 
• Who will have access to the data or specimens? 
• Who is responsible for receipt or transmission of the data or 
specimens? 
• How data and specimens will be transported? 
b.) Local 
Describe the local procedures for maintenance of confidentiality. 
• Where and how data or specimens will be stored locally?  
Consent forms will be stored in a locked cabinet. All other study 
related information will be recorded in the redcap data system. 
• How long the data or specimens will be stored locally? 
3 years. 
• Who will have access to the data or specimens locally? 
Only those listed in the study protocol. A statistician will view de-
identified data after collection for analysis purposes. 
• Who is responsible for receipt or transmission of the data or 
specimens locally? 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
Version Date: 5/6/2014 
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Revised: November 27, 2013  
The principal investigator; Daniel Eisen 
• How data and specimens will be transported locally? 
Data will only be downloaded onto encrypted computers directly from the 
redcap database and only when necessary for study administration or data 
analysis. 
 
15) Provisions to Monitor the Data to Ensure the Safety of Subjects 
This is required when research involves more than Minimal Risk to 
subjects. 
The plan might include establishing a data monitoring committee and a 
plan for reporting data monitoring committee findings to the IRB and the 
sponsor. 
Describe: 
• The plan to periodically evaluate the data collected regarding both 
harms and benefits to determine whether subjects remain safe. 
Risks from this study are minimal. All adverse events will be monitored 
and recorded. Study personnel will immediately share all adverse events 
with the principal investigator.  
• What data are reviewed, including safety data, untoward events, and 
efficacy data. 
Only safety data will be reviewed. Efficacy data will be determined after 
study follow up is completed since this study concerns non-life threatening 
outcomes. 
• How the safety information will be collected (e.g., with case report 
forms, at study visits, by telephone calls with participants). 
Safety information will be collected within the redcap database. 
• The frequency of data collection, including when safety data collection 
starts. 
Safety data collection begins immediately following the procedure. 
Patients will be instructed to call immediately with any complications 
from their procedures. Patients will also be queried at follow up (3 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
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Revised: November 27, 2013  
months) regarding complications in case they fail to call and are treated by 
an outside physician. 
• Who will review the data. 
The principal investigator and study personnel will review the data. 
• The frequency or periodicity of review of cumulative data. 
The study investigator will review safety data weekly after enrollment. 
• The statistical tests for analyzing the safety data to determine whether 
harm is occurring. 
Both interventions in this study are relatively low risk and have been used 
in surgery for decades. Serious adverse events are not expected. Typically 
if one occurs it affects both sides of the wound in the form of infection, 
bleeding, or dehiscence. If the adverse event is localizable to a single site 
it will be recorded as such and the results analyzed after study completion.  
• Any conditions that trigger an immediate suspension of the research. 
Any serious complication, such as hospital admission for treatment related 
to the procedure will trigger cessation of recruitment, until study personnel 
meet and determine it is safe to continue enrolling patients.  
16) Withdrawal of Subjects 
Describe anticipated circumstances under which subjects will be 
withdrawn from the research without their consent. 
None 
Describe any procedures for orderly termination. 
For subjects that do not want to continue to participate in the study, then 
they may do so by informing us by phone or in person or by email. There 
is no risk to early study termination. 
Describe procedures that will be followed when subjects withdraw from 
the research, including partial withdrawal from procedures with 
continued data collection. 
If patients change their mind about participation prior to or during their 
procedure the surgeon will use his or her judgment with regarding the 
spacing of the dermal sutures to close the deep layer of skin. No data 
collection will occur in the future. 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
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Revised: November 27, 2013  
17) Risks to Subjects 
List the reasonably foreseeable risks, discomforts, hazards, or 
inconveniences to the subjects related the subjects’ participation in the 
research. Include as may be useful for the IRB’s consideration, describe 
the probability, magnitude, duration, and reversibility of the risks. 
Consider physical, psychological, social, legal, and economic risks. 
The primary risk of participating is that one side of the wound may look 
different than the other. The author has thus far conducted 5 split scar 
studies and none of the participants from these trials has requested 
revision of the scar based upon differences in appearance of the two 
halves. Typically, differences are not extreme in individuals. Other risks 
are the same for every cutaneous surgical procedure regardless of study 
enrollment: infection, bleeding, dehiscence, 100% chance of scar. Risks of 
bleeding and infection are less than 3% in our facility and typically minor 
in nature. 
If applicable, indicate which procedures may have risks to the subjects 
that are currently unforeseeable. 
The study intervention is commonly performed. Though unforeseeable 
risks are always possible, they are not probable here. 
If applicable, indicate which procedures may have risks to an embryo or 
fetus should the subject be or become pregnant. 
NA 
If applicable, describe risks to others who are not subjects. 
NA 
18) Potential Benefits to Subjects 
Describe the potential benefits that individual subjects may experience 
from taking part in the research. Include as may be useful for the IRB’s 
consideration, the probability, magnitude, and duration of the potential 
benefits. 
Indicate if there is no direct benefit. Do not include benefits to society or 
others. 
No direct benefit to individual subjects. 
19) Vulnerable Populations 
If the research involves individuals who are vulnerable to coercion or 
undue influence, describe additional safeguards included to protect their 
rights and welfare. 
NA 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
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Revised: November 27, 2013  
20) Multi-Site Research 
NA 
21) Community-Based Participatory Research 
NA 
22) Sharing of Results with Subjects 
Results of the study participants own outcome measurements will be 
shared with patient verbally if they request.  
23) Setting 
Patients will be recruited from the University of California, , Dermatology 
Clinic cutaneous surgery practice, 3301 C St, #1300, Sacramento, CA 
95816. 
Research procedures will be performed at the University of California, 
Davis Department of Dermatology cutaneous surgery practice. 3301 C St, 
#1400, Sacramento, CA 95816. 
24) Resources Available 
Principle Investigator- Board Certified Dermatologist with fellowship 
training in cutaneous surgery. Will recruit, enroll, evaluate study subjects 
and oversee study. 
 
Co-Investigator- Procedural Dermatology Fellow: will recruit, enroll, and 
evaluate study subjects. 
 
Board certified dermatologists with fellowship training in cutaneous 
surgery: will recruit, enroll, and evaluate study subjects.  
 
Board certified dermatologists: will recruit, enroll, and evaluate study 
subjects. 
Dermatology residents: will recruit, enroll, and evaluate study subjects. 
 
Study coordinator: will correspond with IRB, perform audits of consent 
forms, and handle administrative requirements of study 
 
Junior Specialist: will correspond with IRB and handle administrative 
requirements of study 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
Version Date: 5/6/2014 
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Revised: November 27, 2013  
 
Patient Record Abstractor: perform research study maintenance in Epic 
and scanning consent forms to Epic. 
 
Approximately 30 patients undergo cutaneous surgeries every week in our 
center. We should easily be able to recruit our required number within 3 
months. 
 
The principle investigator and procedural dermatology fellow will recruit 
and treat patients continuously five days a week.  
 
Outpatient, dermatologic surgery facility with 6 procedure rooms, and 
more than a dozen nursing staff. 
 
No psychological support is likely necessary for those undergoing the 
procedure. Medical help is available in the event of a complication from 
7:30 AM- 5 PM Monday-Friday. An on call resident is available for all 
times the clinic is not available and patients may also visit the Emergency 
Department. 
 
A pre-enrollment meeting will occur where the protocol is carefully 
explained. We will print algorithms for study personnel. They may 
additionally refer to redcap database where the questions will guide them 
through data capture and the procedure. We will also have a lab practicing 
the procedure on a simulated patient mannequin designed for teaching 
cutaneous surgical procedures.  
25) Prior Approvals 
NA 
26) Provisions to Protect the Privacy Interests of Subjects 
Only study personnel and nurses normally present during cutaneous 
procedures and follow-ups will be present. Personal information will be 
obtained just once at study recruitment. It will not be required at follow 
up. 
Examination of the wound will not differ significantly in practice from 
standard medical care, during which a faculty member and resident and 
nurse typically participate in the patients care. In this situation, the number 
of interactions will be the same or less, since only two study investigators 
will be required. Medical students will not participate in study patient 
follow-up evaluation. 
Indicate how the research team is permitted to access any sources of 
information about the subjects. 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
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Access to study information will be permitted only for data entry and for 
study monitoring. Study staff will be requested to only access this 
information for these purposes only. 
27) Compensation for Research-Related Injury 
If the research involves more than Minimal Risk to subjects, describe the 
available compensation in the event of research related injury. 
No compensation will be provided.  
Economic Burden to Subjects 
No additional cost to participate in the study will be incurred. Standard of 
care and other routine costs will be billed to the patient or the patient’s 
insurance carrier, Medicare, or Medi-cal, where appropriate. Only the 
costs of research and experimental procedures will be paid by the 
sponsor/department 
28) Consent Process 
We will obtain written informed consent from all subjects. Study 
personnel will be obtaining consent in person at the Dermatology clinic at 
3301 C St, #1300, Sacramento, CA 95816. Patients will be given as much 
time as they like to consider enrolling. 
We will review the consent form binder once a month to ascertain 
signatures on the consent and HIPAA forms. The study coordinator, Lam 
Nguyen will review the binder independently at routine intervals. 
Our experience from past studies indicates it takes less than 5 minutes to 
explain the study. The subject will be allowed to take as much time as they 
like to read the forms, ask questions or consider participation.  
We will inform the subject that enrollment is optional and that we will 
treat them without bias and with all the quality that they should normally 
expect outside of study participation. 
Subjects will be asked if they understand the study and if they have any 
questions. 
We will not enroll anyone who does not understand written or verbal 
English. The vast majority of our cutaneous surgical population is English 
speaking. 
 

PROTOCOL TITLE: Interrupted subdermal suture spacing during linear wound closures 
and the effect on wound cosmesis: a randomized evaluator blinded split wound 
comparative effectiveness trial   
Version Date: 5/6/2014 
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Revised: November 27, 2013  
Waiver or Alteration of the Consent Process (consent will not be 
obtained, required information will not be disclosed, or the research 
involves deception) 
NA 
Subjects who are not yet adults (infants, children, teenagers) 
NA 
Cognitively Impaired Adults 
NA 
Adults Unable to Consent 
NA 
Adults Unable to Consent 
NA 
For HUD uses provide a description of how the patient will be informed of 
the potential risks and benefits of the HUD and any procedures associated 
with its use. 
29) Process to Document Consent in Writing 
We will follow “SOP: Written Documentation of Consent (HRP-091)” 
 
30) Drugs or Devices 
NA 
 
 
 
References  
After completing a literature search, it has been determined that there are no publications, 
recommendations, or studies invetigating the relationship between interrupted 
subdermal suture spacing and wound cosmesis.