Suture Repair of Lacerations in the Emergency Department: Comparison Between Absorbable and Non-absorbable Suture Material
Phase: NA
Conditions: Laceration of Hand, Laceration of Forearm
Sponsor: Kenneth Taylor, M.D.

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HRP-591 - Protocol for 
Human Subject Research
Protocol Title:
Provide the full title of the study as listed in item 1 on the “Basic Information” page in CATS IRB (http://irb.psu.edu). 
Suture Repair of Lacerations in the Emergency Department: Comparison between Absorbable and Non-absorbable 
Suture Material 
Principal Investigator:
Name: Kenneth Taylor, MD  
Department: Department of Orthopaedics and Rehabilitation
Telephone: 717-531-5638   
E-mail Address: ktaylor3@pennstatehealth.psu.edu
Version Date:
Provide a version date for this document. This date must be updated each time this document is submitted to the IRB 
office with revisions.  DO NOT revise the version date in the footer of this document. 
November 30, 2022
Clinicaltrials.gov Registration #:
Provide the registration number for this study, if applicable. See “HRP-103- Investigator Manual”, under 
“ClinicalTrials.gov” for more information. 
NCT05281666
Important Instructions for Using This Protocol Template:
This template is provided to help investigators prepare a protocol that includes the necessary information needed by the 
IRB to determine whether a study meets all applicable criteria for approval.
1.
GENERAL INSTRUCTIONS:  

Prior to completing this protocol, ensure that you are using the most recent version by verifying the protocol 
template version date in the footer of this document with the current version provided in the CATS IRB 
Library.

Do not change the protocol template version date located in the footer of this document.

Some of the items may not be applicable to all types of research.  If an item is not applicable, please indicate 
as such or skip question(s) if indicated in any of the instructional text. 

GRAY INSTRUCTIONAL BOXES: Type your protocol responses below the gray instructional boxes of guidance 
language.  If the section or item is not applicable, indicate not applicable.
o
Do NOT delete the instructional boxes from the final version of the protocol.

Add the completed protocol template to your study in CATS IRB (http://irb.psu.edu) on the “Basic 
Information” page.  
2.
CATS IRB LIBRARY: 

Documents referenced in this protocol template (e.g. SOP’s, Worksheets, Checklists, and Templates) can be 
accessed by clicking the Library link in CATS IRB (http://irb.psu.edu).
3.
PROTOCOL REVISIONS: 

When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in 
the guides available in the Help Center in CATS IRB (http://irb.psu.edu) for using track changes. 

Update the Version Date on page 1 each time this document is submitted to the IRB office with revisions.
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If you need help…
All locations: 
Human Research Protection Program
Office for Research Protections
The 330 Building, Suite 205
University Park, PA 16802-7014
Phone: 814-865-1775
Fax: 814-863-8699
Email: irb-orp@psu.edu
https://www.research.psu.edu/irb
Table of Contents
1.0
Objectives
2.0
Background
3.0
Inclusion and Exclusion Criteria
4.0
Recruitment Methods
5.0
Consent Process and Documentation
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
7.0
Study Design and Procedures
8.0
Number of Subjects and Statistical Plan
9.0
Data and Safety Monitoring Plan
10.0
Risks
11.0
Potential Benefits to Subjects and Others
12.0
Sharing Results with Subjects
13.0
Subject Payment and/or Travel Reimbursements
14.0
Economic Burden to Subjects
15.0
Resources Available
16.0
Other Approvals
17.0
Multi-Site Study
18.0
Adverse Event Reporting
19.0
Study Monitoring, Auditing and Inspecting
20.0
Future Undetermined Research: Data and Specimen Banking
21.0
References
22.0
Confidentiality, Privacy and Data Management
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1.0
Objectives
1.1
Study Objectives
Describe the purpose, specific aims or objectives.  State the hypotheses to be tested.
The purpose of the study is to evaluate the use of absorbable and non-absorbable suture material in 
hand lacerations repaired in the Penn State Health Milton S. Hershey (PSHMC) Emergency Department. 
1.2
Primary Study Endpoints
State the primary endpoints to be measured in the study.  
Clinical trials typically have a primary objective or endpoint. Additional objectives and endpoints are 
secondary.  The endpoints (or outcomes), determined for each study subject, are the quantitative 
measurements required by the objectives.  Measuring the selected endpoints is the goal of a trial 
(examples: response rate and survival).
The primary endpoints of this study consist of evaluating wound healing using the Patient and Observer 
Scar Assessment Scale1 (POSAS).  This scale includes assessment by the observer (vascularization, 
pigmentation, thickness, relief, and pliability), as well as by the patient (scar pain, itching, color, 
stiffness, irregularity, and stiffness). There will be a single observer for this study to eliminate any 
interrater bias, and this observer will be a clinician different from the one who removes the sutures. 
1.3
Secondary Study Endpoints
State the secondary endpoints to be measured in the study.
The secondary study endpoints will measure patient reported pain of the scar itself as well as suture 
removal for those with non-absorbable sutures through the use of the visual analogue pain scale (VAS), 
a commonly used scale to judge patients’ pain levels.  We will also record the following: 
-
Hematoma rate 
-
Infection rate (requiring either antibiotics or operative intervention) 
-
Time off of work
2.0
Background 
2.1
Scientific Background and Gaps
Describe the scientific background and gaps in current knowledge. 
For clinical research studies being conducted at Penn State Health/Penn State College of Medicine, and 
for other non-PSH locations as applicable, describe the treatment/procedure that is considered standard 
of care (i.e., indicate how patients would be treated in non-investigational setting); and if applicable, 
indicate if the study procedure is available to patient without taking part in the study.
There has been limited data published on suture type in traumatic hand wounds.  The only study we 
found in our literature review was a retrospective study comparing vicryl vs. nylon suture, and found no 
difference in scar appearance, tenderness, retraction, or complications as far as 6 months after repair2.  
There have been no prospective studies on this topic.  The theoretical advantage of absorbable suture 
for these wounds is they do not require suture removal, thereby removing the discomfort of suture 
removal as well potentially decreasing the burden of follow up. 
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At Penn State Hershey Medical Center, either suture choice included in this study is considered standard 
of care and is routinely used.  Selection as to whether absorbable or non-absorbable suture is used is 
based on the preference and discretion of the resident and attending surgeon involved in the patient 
care.  As such, if patient were to present to the emergency department with a forearm or hand 
laceration and hand surgery were consulted, regardless of whether the patient opts to participate in this 
research study,  their laceration would be repaired with either absorbable or non-absorbable suture 
depending on provider preference and the patient would be scheduled follow up. 
2.2
Previous Data
Describe any relevant preliminary data.
There have been multiple prospective clinical trials on suture type in the context of planned surgical 
incisions, specifically carpal tunnel release, with variable outcomes.  One clinical trial looking at a total of 
40 incisions found no difference in pain, tenderness, inflammation, or outcomes postoperatively3.  
Certain clinical trials favored non-absorbable sutures, reporting higher rate of infection4 or 
inflammation5 with vicryl suture as compared to non-braided, non-absorbable sutures.   On the other 
hand, other clinical trials favored absorbable sutures, describing reduction in pain scores6 and pain 
associated with absorbable suture removal in the setting of other equivalent outcomes7. 
2.3
Study Rationale
Provide the scientific rationale for the research.
This study aims to determine whether the use of non-absorbable (i.e. nylon) versus absorbable (i.e. 
chromic gut) sutures in traumatic hand lacerations affects wound healing, patient perception, and 
development of complications.  
3.0
Inclusion and Exclusion Criteria
Create a numbered list below in sections 3.1 and 3.2 of criteria subjects must meet to be eligible for study 
enrollment (e.g., age, gender, diagnosis, etc.). 
Vulnerable Populations:
Indicate specifically whether you will include any of the following vulnerable populations in this research. You 
MAY NOT include members of these populations as subjects in your research unless you indicate this in your 
inclusion criteria because specific regulations apply to studies that involve vulnerable populations.  
The checklists referenced below outline the determinations to be made by the IRB when reviewing research 
involving these populations. Review the checklists as these will help to inform your responses throughout the 
remainder of the protocol.

Children –Review “HRP-416- Checklist - Children”

Pregnant Women – Review “HRP-412- Checklist - Pregnant Women”

Cognitively Impaired Adults- Review “HRP-417- Checklist - Cognitively Impaired Adults” 

Prisoners- Review “HRP-415- Checklist - Prisoners”

Neonates of uncertain viability or non-viable neonates- Review “HRP-413- Checklist - Non-Viable 
Neonates” or “HRP-414- Checklist - Neonates of Uncertain Viability”
[Do not type here]
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3.1
Inclusion Criteria
Create a numbered list of the inclusion criteria that define who will be included in your final study 
sample (e.g., age, gender, condition, etc.) 

Subject seen in PSHMC Emergency Department for hand or forearm lacerations (i.e. laceration 
below the level of the elbow) that require suture repair, in which hand surgery is consulted

CDC surgical wound classification grades I-IV (Table 1)

Age >18 years of age 

Gender:  male or female (non-pregnant)

Fluent in written and spoken English

Subject is able to provide voluntary, written informed consent

Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and 
is willing to perform all study procedures and follow-up visits

Non-Prisoners
3.2 Exclusion Criteria
Create a numbered list of the exclusion criteria that define who will be excluded in your study.

Known allergy to suture material

History of immunosuppression (i.e. concurrent chemotherapy, steroid use or immunomodulatory 
therapy) 

History of diabetes mellitus 

Pregnancy 

Current Tobacco use

Age < 18 years old

Previous skin laceration at same location

History of previous hypertrophic or keloid scar

Concurrent tendon, nerve or bone injury requiring trip to the operating room

Non-English speaking patients

Cognitive impairment 

Prisoners
3.3
Early Withdrawal of Subjects
3.3.1
Criteria for removal from study
Insert subject withdrawal criteria (e.g., safety reasons, failure of subject to adhere to protocol 
requirements, subject consent withdrawal, disease progression, etc.).
Subjects will be withdrawn from the study for safety reasons including failure of subject to 
adhere to protocol requirements, safety concerns related to the study, or subject consent 
withdrawal.
3.3.2
Follow-up for withdrawn subjects
Describe when and how to withdraw subjects from the study; the type and timing of the data to 
be collected for withdrawal of subjects; whether and how subjects are to be replaced; the 
follow-up for subjects withdrawn from investigational treatment.
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If a subject is withdrawn from the study, data collection will be terminated from that time point 
forward.  All prior data collected will be included in the analysis. These subjects will not be 
replaced, but instead more subjects may need to be enrolled. These new data will be recorded 
and analyzed as would any other new enrollee.
4.0
Recruitment Methods
Upload recruitment materials for your study in CATS IRB (http://irb.psu.edu).  DO NOT include the actual 
recruitment wording in this protocol.  
StudyFinder:  If StudyFinder (http://studyfinder.psu.edu) is to be used for recruitment purposes, separate 
recruitment documents do not need to be uploaded in CATS IRB. The necessary information will be captured 
from the StudyFinder page in your CATS IRB study.  
Any eligibility screening questions (verbal/phone scripts, email, etc.) used when contacting potential 
participants must be uploaded to your study in CATS IRB (http://irb.psu.edu).
[Do not type here]
4.1
Identification of subjects
Describe the source of subjects and the methods that will be used to identify potential subjects (e.g., 
organizational listservs, established recruitment databases, subject pools, medical or school records, 
interactions during a clinic visit, etc.).   If not recruiting subjects directly (e.g., database query for eligible 
records or samples) state what will be queried, how and by whom.
StudyFinder:  
o
If you intend to use StudyFinder (http://studyfinder.psu.edu) for recruitment purposes, include this 
method in this section. 
o
Information provided in this protocol needs to be consistent with information provided on the 
StudyFinder page in your CATS IRB study.
For Penn State Health submissions using Enterprise Information Management (EIM) for recruitment, and 
for non-Hershey locations as applicable, attach your EIM Design Specification form on in CATS IRB 
(http://irb.psu.edu). See “HRP-103- Investigator Manual, What is appropriate for study recruitment?” 
for additional information. DO NOT include the actual recruitment material or wording in this protocol.
Subjects will be identified through their clinical encounter in the Emergency Department.  The 
Emergency Department staff will contact the hand surgery resident on call to inform them of a patient 
who requires a laceration repair that requires hand surgery consultation. Subjects who meet the 
inclusion criteria will be offered participation in the study at the time of their Emergency Department 
visit by a hand surgery resident who is a study team member.  
4.2
Recruitment process
Describe how potential subjects first learn about this research opportunity or indicate as not applicable 
if subjects will not be prospectively recruited to participant in the research.  Subject recruitment can 
involve various methods (e.g., approaching potential subjects in person, contacting potential subjects via 
email, letters, telephone, ResearchMatch, or advertising to a general public via flyers, websites, 
StudyFinder, newspaper, television, and radio etc.). DO NOT include the actual recruitment material or 
wording in this protocol.
[Do not type here]
4.2.1
How potential subjects will be recruited.
Subjects will be recruited after they are identified and a diagnosis is made.  Inclusion/exclusion 
criteria will then be reviewed to confirm eligibility.  
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4.2.2
Where potential subjects will be recruited.
Subjects will be recruited at time of visit in the PSHMC Emergency Department. 
4.2.3
When potential subjects will be recruited.
Subjects will be recruited by a study team member prior to laceration repair.
4.2.4
Describe the eligibility screening process and indicate whether the screening process will occur 
before or after obtaining informed consent. Screening begins when the investigator obtains 
information about or from a prospective participant in order to determine their eligibility.  In 
some studies, these procedures may not take place unless HIPAA Authorization is obtained OR 
a waiver of HIPAA Authorization when applicable for the screening procedures is approved by 
the IRB.  [For FDA regulated studies, consent for any screening activities would need to be 
obtained prior to screening unless specifically waived by the IRB.]
Adult subjects presenting to the PSHMC Emergency Department will be evaluated as part of 
standard of care. Those subjects meeting eligibility requirements will be presented with the 
opportunity to participate in the research study by a member of the study team.
5.0
Consent Process and Documentation 
Refer to the following materials:

The “HRP-090- SOP - Informed Consent Process for Research” outlines the process for obtaining informed 
consent.  

The “HRP-091– SOP - Written Documentation of Consent” describes how the consent process will be 
documented.

The “HRP-314- Worksheet - Criteria for Approval” section 7 lists the required elements of consent.

The “HRP-312- Worksheet - Exemption Determination” includes information on requirements for the 
consent process for exempt research.  In addition, the CATS IRB Library contains consent guidance and 
templates for exempt research.

The CATS IRB library contains various consent templates for expedited or full review research that are 
designed to include the required information.

Add the consent document(s) to your study in CATS IRB (http://irb.psu.edu). Links to Penn State’s consent 
templates are available in the same location where they are uploaded. DO NOT include the actual consent 
wording in this protocol.
[Do not type here]
5.1
Consent Process:
Check all applicable boxes below:
 Informed consent will be sought and documented with a written consent form [Complete Sections 
5.2 and 5.6] 
 Implied or verbal consent will be obtained – subjects will not sign a consent form (waiver of 
written documentation of consent) [Complete Sections 5.2, 5.3 and 5.6] 
  Informed consent will be sought but some of the elements of informed consent will be omitted or 
altered (e.g., deception). [Complete section 5.2, 5.4 and 5.6] 
 Informed consent will not be obtained – request to completely waive the informed consent 
requirement. [Complete Section 5.5]
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The following checkbox is for all locations EXCEPT Penn State Health and College of Medicine: 
 
 Exempt Research at all Locations Except Penn State Health and the College of Medicine: If you 
believe that the research activities outlined meet one or more of the criteria outlined in “HRP-312- 
Worksheet- Exemption Determination.” Please verify by checking this box that if conducting an 
exempt research study, the consent process will disclose the following (all of which are included in 
“HRP-590- Consent Guidance for Exempt Research”):
Penn State affiliation; name and contact information for the researcher and advisor (if the 
researcher is a student); the activities involve research; the procedures to be performed; 
participation is voluntary; that there are adequate provisions to maintain the privacy interests of 
subjects and the confidentiality of the data; and subjects may choose not to answer specific 
questions.  
If the research includes the use of student educational records include the following language in 
this section (otherwise delete): 
Note: If this box has been checked, skip the remainder of section 5 and proceed to section 6 of this 
protocol. If the investigator’s assessment is inaccurate, an IRB Analyst will request revision to the 
protocol and that an informed consent form be submitted for review and approval. Except for 
exemptions where Limited IRB Review (see “HRP-312- Worksheet- Exemption Determination”) is 
required or where otherwise requested by the IRB, informed consent forms for research activities 
determined to be exempt without Limited IRB Review are generally not required to be submitted 
for review and approval by the University Park IRB. 
5.2
Obtaining Informed Consent 
5.2.1
Timing and Location of Consent 
Describe where and when the consent process will take place.
Subjects presenting to the PSHMC Emergency Department for evaluation will be given the 
opportunity to participate in the research study.  Subjects will be given information about the 
study and asked to participate. If eligible, based on inclusion and exclusion criteria, Informed 
Consent will be obtained at the time of the screening visit and the subject will be enrolled in 
the study.  
5.2.2
Coercion or Undue Influence during Consent 
Describe the steps that will be taken to minimize the possibility of coercion or undue influence 
in the consent process.
Study procedures will be fully explained, voluntariness will be emphasized as well as the fact 
that no care will be denied regardless of the subjects decision. Subjects will be given ample 
time to read and review the consent form on their own. All questions the subject may have will 
be answered, and written consent will be obtained. A member of the research team will assist 
in the explanation and obtaining of the written consent. A copy of the signed consent will be 
given to the subject and another copy sent to Medical Records.
 
5.3
Waiver of Written Documentation of Consent 
Review “HRP – 411 – Checklist – Waiver of Written Documentation of Consent.” 
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5.3.1
Indicate which of the following conditions applies to this research:
  The research presents no more that minimal risk of harm to subjects and involves no 
procedures for which written consent is normally required outside of the research context.
OR
  The only record linking the subject and the research would be the consent document and the 
principal risk would be potential harm resulting from a breach of confidentiality. Each subject 
will be asked whether the subject wants documentation linking the subject with the research, 
and the subject’s wishes will govern. (Note: This condition is not applicable for FDA-regulated 
research. If this category is chosen, include copies of a consent form and /or parental 
permission form for participants who want written documentation linking them to the 
research.)
OR
  If the subjects or legally authorized representatives are members of a distinct cultural group 
or community in which signing forms is not the norm, that the research presents no more 
than minimal risk of harm to subjects and provided there is an appropriate alternative 
mechanism for documenting that informed consent was obtained.  (Note: This condition is not 
applicable for FDA-regulated research.) 
Describe the alternative mechanism for documenting that informed consent was obtained:
N/A
5.3.2
Indicate what materials, if any, will be used to inform potential subjects about the research 
(e.g., a letter accompanying a questionnaire, verbal script, implied consent form, or summary 
explanation of the research)
N/A
5.4
Informed consent will be sought but some of the elements of informed consent will be omitted or 
altered (e.g., deception).
Review “HRP-410-Checklist -Waiver or Alteration of Consent Process” to ensure that you have provided 
sufficient information.  
5.4.1
Indicate the elements of informed consent to be omitted or altered
N/A
5.4.2
Indicate why the research could not practicably be carried out without the omission or 
alteration of consent elements
N/A
5.4.3
Describe why the research involves no more than minimal risk to subjects.
N/A
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5.4.4
Describe why the alteration/omission will not adversely affect the rights and welfare of 
subjects.
N/A
5.4.5
If the research involves using identifiable private information or identifiable biospecimens, 
describe why the research could not be practicably be carried out without using such 
information or biospecimens in an identifiable format.
N/A
5.4.6
Debriefing 
Explain whether and how subjects will be debriefed after participation in the study. If subjects 
will not be debriefed, provide a justification for not doing so.  Add any debriefing materials to 
the study in CATS IRB.
N/A
5.5
Informed consent will not be obtained – request to completely waive the informed consent 
requirement
Review “HRP-410-Checklist -Waiver or Alteration of Consent Process” to ensure that you have provided 
sufficient information.
5.5.1
Indicate why the research could not practicably be carried out without the waiver of consent
A waiver is necessary for prescreening purposes only to determine subject eligibility.  Patient 
identifiers are necessary for identification and review of the patient’s medical records.  
5.5.2
Describe why the research involves no more than minimal risk to subjects.
Access to the patient’s medical records for prescreening purposes presents no more than 
minimal risk.
5.5.3
Describe why the alteration/omission will not adversely affect the rights and welfare of 
subjects.
Subjects will not be adversely affected by this alteration/omission.  The waiver is to review the 
patient’s medical records for prescreening/study eligibility purposes only.
5.5.4
If the research involves using identifiable private information or identifiable biospecimens, 
describe why the research could not be practicably be carried out without using such 
information or biospecimens in an identifiable format.
Patient identifiers are necessary for identification and review of the patient’s medical records.  A 
unique study code number will be used for identification of study data.
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5.5.5
Additional pertinent information after participation
Explain if subjects will be provided with additional pertinent information after participation. If 
not applicable, indicate “not applicable.”   
N/A
5.6
Consent – Other Considerations 
5.6.1
Non-English-Speaking Subjects
Indicate what language(s) other than English are understood by prospective subjects or 
representatives.
If subjects who do not speak English will be enrolled, describe the process to ensure that the 
oral and written information provided to those subjects will be in that language. Indicate the 
language that will be used by those obtaining consent.
Indicate whether the consent process will be documented in writing with the long form of the 
consent documentation or with the short form of the consent documentation.  Review “HRP-
091 –SOP- Written Documentation of Consent” and “HRP-103 -Investigator Manual” to ensure 
that you have provided sufficient information. 
N/A
5.6.2
Cognitively Impaired Adults
Refer “HRP-417 -CHECKLIST- Cognitively Impaired Adults” for information about research 
involving cognitively impaired adults as subjects. 
5.6.2.1 Capability of Providing Consent
Describe the process to determine whether an individual is capable of consent.
N/A
5.6.2.2
Adults Unable to Consent
Describe whether and how informed consent will be obtained from the legally 
authorized representative.  Describe who will be allowed to provide informed 
consent. Describe the process used to determine these individual’s authority to 
consent to research.
For research conducted in the state of Pennsylvania, review “HRP-013 -SOP- Legally 
Authorized Representatives, Children and Guardians” to be aware of which 
individuals in the state of Pennsylvania meet the definition of “legally authorized 
representative.”
For research conducted outside of the state of Pennsylvania, provide information 
that describes which individuals are authorized under applicable law to consent on 
behalf of a prospective subject to their participation in the procedure(s) involved in 
this research.  One method of obtaining this information is to have a legal counsel or 
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authority review your protocol along with the definition of “children” in “HRP-013 -
SOP- Legally Authorized Representatives, Children, and Guardians.”
N/A
5.6.2.3 Assent of Adults Unable to Consent
Describe the process for assent of the subjects.  Indicate whether assent will be 
required of all, some or none of the subjects.  If some, indicate which subjects will 
be required to assent and which will not. 
If assent will not be obtained from some or all subjects, provide an explanation of 
why not.
Describe whether assent of the subjects will be documented and the process to 
document assent.  The IRB allows the person obtaining assent to document assent 
on the consent document and does not routinely require assent documents and 
does not routinely require subjects to sign assent documents.
N/A
5.6.3
Subjects who are not yet adults (infants, children, teenagers) 
5.6.3.1 Parental Permission
Describe whether and how parental permission will be obtained. If permission will 
be obtained from individuals other than parents, describe who will be allowed to 
provide permission.  Describe the process used to determine these individual’s 
authority to consent to each child’s general medical care.
For research conducted in the state of Pennsylvania, review “HRP-013-SOP- Legally 
Authorized Representatives, Children and Guardians” to be aware of which 
individuals in the state of Pennsylvania meet the definition of “children.” 
For research conducted outside of the state of Pennsylvania, provide information 
that describes which persons have not attained the legal age for consent to 
treatments or procedures involved in the research, under the applicable law of the 
jurisdiction in which research will be conducted.  One method of obtaining this 
information is to have a legal counsel or authority review your protocol along with 
the definition of “children” in “HRP-013-SOP- Legally Authorized Representatives, 
Children, and Guardians.”
N/A
5.6.3.2 Assent of subjects who are not yet adults
Indicate whether assent will be obtained from all, some, or none of the children. If 
assent will be obtained from some children, indicate which children will be required 
to assent. When assent of children is obtained describe whether and how it will be 
documented.
N/A
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6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
This section is about the access, use or disclosure of Protected Health Information (PHI). PHI is individually 
identifiable health information (i.e., health information containing one or more 18 identifiers) that is transmitted 
or maintained in any form or medium by a Covered Entity or its Business Associate. A Covered Entity is a health 
plan, a health care clearinghouse or health care provider who transmits health information in electronic form.  
See “HRP-103 -Investigator Manual” for a list of the 18 identifiers.  
If requesting a waiver/alteration of HIPAA authorization, complete sections 6.2 and 6.3 in addition to section 
6.1. The Privacy Rule permits waivers (or alterations) of authorization if the research meets certain conditions. 
Include only information that will be accessed with the waiver/alteration. 
[Do not type here]
6.1
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
Check all that apply:
 
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable]
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable]
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3]
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3]
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3]
6.2
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
6.2.1
Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual
6.2.1.1
Plan to protect PHI from improper use or disclosure
Include the following statement as written – DO NOT ALTER OR DELETE 
unless this section is not applicable because the research does not involve a 
waiver of authorization. If the section is not applicable, remove the 
statement and indicate as not applicable. 
Information is included in the “Confidentiality, Privacy and Data 
Management” section of this protocol.
6.2.1.2
Plan to destroy identifiers or a justification for retaining identifiers 
Describe the plan to destroy the identifiers at the earliest opportunity 
consistent with the conduct of the research. Include when and how 
identifiers will be destroyed. If identifiers will be retained, provide the legal, 
health or research justification for retaining the identifiers.
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Linking code list will be destroyed upon completion of the study.
6.2.2
Explanation for why the research could not practicably be conducted without access to and use 
of PHI
Provide an explanation for why the research could not practicably be conducted without access 
to and use of PHI.
Patient identifiers are necessary for identification and review of the patient’s medical records.  A 
unique study code number will be used for identification of study data.  
6.2.3
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization
Provide an explanation for why the research could not practicably be conducted without the 
waiver or alternation of authorization.
PHI is required during the recruitment process to determine subject eligibility.
6.3
Waiver or alteration of authorization statements of agreement
By submitting this study for review with a waiver of authorization, you agree to the following statement – 
DO NOT ALTER OR DELETE unless this section is not applicable because the research does not involve a 
waiver or alteration of authorization. If the section is not applicable, remove the statement and indicate 
as not applicable.
Protected health information obtained as part of this research will not be reused or disclosed to any 
other person or entity, except as required by law, for authorized oversight of the research study, or for 
other permitted uses and disclosures according to federal regulations. 
The research team will collect only information essential to the study and in accord with the ‘Minimum 
Necessary’ standard (information reasonably necessary to accomplish the objectives of the research) per 
federal regulations. 
Access to the information will be limited, to the greatest extent possible, within the research team. All 
disclosures or releases of identifiable information granted under this waiver will be accounted for and 
documented.
7.0
Study Design and Procedures
Data collection materials that will be seen or used by subjects in your study must be uploaded to CATS IRB 
(http://irb.psu.edu).   DO NOT include any actual data collection materials in this protocol (e.g., actual survey or 
interview questions)
[Do not type here]
7.1
Study Design
Describe and explain the study design.
This study is a prospective, randomized, single observer blinded study evaluating the use of absorbable 
and non-absorbable suture material in lacerations below the level of the forearm.   Both types of suture 
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material are current standard of care.  Prior to washout and repair, the patient’s wound will be classified 
according to the surgical wound classification system and sent home with 1 week of antibiotics (Keflex, 
unless an allergy precludes this option) as part of their standard of care treatment8.  Subjects will then 
be seen back in clinic at 2, 6, and 12 weeks as part of their standard of care treatment.  At two weeks, 
sutures will be removed.
Recruitment → Randomization → Wound suture (absorbable vs non-absorbable material) → Return to 
clinic site at 2, 6, and 12 weeks
ED*
2 weeks (Hand Clinic)*,**
6 weeks (Hand Clinic)*,**
12 weeks (Hand Clinic)*,**
Initial Visit
Follow-up visit
Follow-up visit
Follow-up visit 
Suture of wound 
Suture removal
VAS (research)
VAS (research)
Inclusion/Exclusion 
Criteria (research) 
VAS (research)
POSAS (research)
POSAS (research)
Informed Consent 
(research) 
POSAS (research)
Randomization (research) 
  * All visits are standard of care
**Study team member at 2, 6, and 12 weeks is a blinded, single observer
7.2
Study Procedures
Provide a step by step description of all research procedures being conducted (broken down by visit, if 
applicable) including such information as below (where and when applicable); describe the following:

HOW: (e.g., data collection via interviews, focus groups, forms such as surveys and questionnaires, 
medical/school records, audio/video/digital recordings, photographs, EKG procedures, MRI, mobile 
devices such as electronic tablets/cell phones, observations, collection of specimens, experimental 
drug/device testing, manipulation of behavior/use of deception, computer games, etc.)

WHERE: (e.g., classrooms, labs, internet/online, places of business, medical settings, public spaces, 
etc.)
7.2.1
Visit 1 – Enrollment (ED Visit)
Provide a description of what procedures will be performed on visit 1 or day 1 or pre-test in 
order of how these will be done.  If your study only involves one session or visit, use this section 
only and indicate 7.2.2 as not applicable. 
Visit 1: Subject presents to Emergency Department with lacerations below the level of 
the forearm.  Subjects that meet inclusion criteria will be identified and consented.  
Ample time will be allowed for informed consent. The risk of keeping the wound open 
the additional time to obtain informed consent is considered low. Subjects will be 
randomized utilizing the National Cancer Institute Clinical Trial Randomization Tool 
(https://ctrandomization.cancer.gov/home/) and placed into one of two study groups – 
absorbable or non-absorbable suture material.  Prior to washout and repair, the 
patient’s wound will be classified according to the CDC surgical wound classification 
system. The washout and laceration repair will then be done in a standard fashion using 
1 liter of normal saline to irrigate the wound, and closure of the wound using a 
horizontal mattress type of stitch.  
Information will be collected from the subject’s EMR and entered into a data collection 
form – age, gender, laterality, comorbidities, wound classification, location of laceration, 
mechanism, contamination, tissue involved, and antibiotics given.
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There is not a classification that would indicate the use of either of the two suture 
materials.  There is also not a classification that would put a subject at greater risk if 
randomized to one material versus another.  Both sutures are used in multiple 
classification settings per physician preference.
Both suture types are appropriate in nearly any setting aside from those who meet 
exclusion criteria.  There is little concern that taking away the physician or participant 
choice to suture material could make the risk greater than the physician just seeing the 
patient and using whatever material is preference.
The treatment of any adverse event would not be affected by suture type. If an event 
were to occur prior to suture removal, the subject may be seen by the on-call or clinic 
team (non-study personnel). This would be recorded as an adverse event and treated 
accordingly. If seen by the blinded observer prior to suture removal, the observer would 
be unblinded, treat the event accordingly, and record it as an AE.
7.2.2
Visit 2 – 2-weeks following ED Visit (Hand Clinic)
Provide a description of what procedures will be performed on visit 2 or day 2 or post-test in 
order of how these will be done.  If your study involves more than two sessions or visits 
replicate this section for each additional session or visit (e.g., 7.2.3, 7.2.4, etc.). 
Visit 2: Subjects will be seen in the Hand Clinic approximately 2 weeks after their initial 
Emergency Department visit.  At this time, subjects in the non-absorbable suture material group 
will have their sutures removed.  All subjects will have their wound assessed by a blinded single 
observer, utilizing the POSAS and VAS.
7.2.3
Visit 3 - 6-weeks following ED Visit (Hand Clinic)
Provide a description of what procedures will be performed on visit 2 or day 2 or post-test in 
order of how these will be done.  If your study involves more than two sessions or visits 
replicate this section for each additional session or visit (e.g., 7.2.3, 7.2.4, etc.). 
Visit 3: At the subject’s 6-week follow-up clinic appointment, all subjects will have their wound 
assessed by a blinded single observer, utilizing the POSAS and VAS.
Visit 4 - 12-weeks following ED Visit (Final Visit in Hand Clinic)
Provide a description of what procedures will be performed on visit 2 or day 2 or post-test in 
order of how these will be done.  If your study involves more than two sessions or visits 
replicate this section for each additional session or visit (e.g., 7.2.3, 7.2.4, etc.). 
Visit 4: At the subject’s 12-week follow-up clinic appointment, all subjects will have their wound 
assessed by a blinded single observer, utilizing the POSAS and VAS.  
7.3
Duration of Participation
Describe how long subjects will be involved in this research study.  Include the number of sessions and 
the duration of each session - consider the total number of minutes, hours, days, months, years, etc.  
Approximately 12 weeks from time of initial Emergency Department encounter until last clinic follow-up 
visit. 
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7.4
Test Article(s) (Study Drug(s) and/or Study Device(s))
7.4.1
Description
Provide a brief description of all test articles (drugs (including any foods and dietary 
supplements), devices and/or biologics used in the research including the purpose of their use 
and their approval status with the Food and Drug Administration (FDA). Include information 
about the form of the drug product (e.g., tablets, capsules, liquid).
The two suture materials used in this study are chromic gut (absorbable) and nylon suture (non-
absorbable).  Both are products of Ethicon and FDA approved.   Both are monofilament sutures 
used as standard practice as suture material.  Chromic gut suture loses its tensile strength in 
approximately 10-21 days and fully dissolves over the course of three months.
7.4.2
Treatment Regimen
Describe dose, route of administration and treatment duration. Include information about dose 
adjustments.
N/A – This study involves suture material that is applied to a wound once.  The nylon suture 
(non-absorbable) will be removed at the subject’s 2-week follow-up appointment. There is no 
drug administration.
7.4.3
Method for Assigning Subject to Treatment Groups
Describe the randomization process and how the associated treatment assignment will be 
made.
Subjects will be randomized utilizing the National Cancer Institute Clinical Trial Randomization 
Tool (https://ctrandomization.cancer.gov/home/) and placed into one of two study groups – 
absorbable or non-absorbable suture material.
7.4.4
Subject Compliance Monitoring
Insert the procedures for monitoring subject compliance.
Subject compliance will be determined based on whether subjects come to their follow-up 
appointments where sutures will be removed (in the nylon suture group) and assessments will 
be made, as described previously.  Subjects in the absorbable suture group are also asked to 
return for follow-up to assess wound healing and subject compliance is determined in the same 
manner.
7.4.5
Blinding of the Test Article
Describe how the test article is blinded.
The single observer who sees subjects at the 2, 6, and 12-week follow-up visits will be blinded.
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7.4.6
Receiving, Storage, Dispensing and Return 
7.4.6.1
Receipt of Test Article 
Describe how the test article will be obtained and from what source. 
Describe how the study test article will be packaged along with amounts 
(e.g., number of tablets/capsules or volume of liquid) and labeling. If drug 
kits are used, describe all the contents of the kit and associated labeling.
Both suture materials are current standard of care treatment and available 
in the Emergency Department.  A study device log will be utilized to record 
details of each suture device that is used for the study.
7.4.6.2
Storage
Describe the plans to store, handle the test article so they will be used only 
on subjects and only by authorized investigators. Describe storage 
temperature requirements and how temperature will be monitored and 
recorded.
All suture material used in the Emergency Department is obtained from the 
Emergency Department laceration carts.  They are stored at room 
temperature.
7.4.6.3
Preparation and Dispensing
Describe how the test article will be assigned to each subject and 
dispensed. Describe the steps necessary to prepare the test article. Include 
where the test article preparation will be done and by whom. Fully 
describe how the study treatment is to be administered and by whom.
Subjects will be assigned to groups based on methods previously described.
7.4.6.4
Return or Destruction of the Test Article
Describe the procedures for final reconciliation of the test article supply at 
the end of the study and whether the test article is to be shipped back to a 
source or destroyed on site.
Absorbable sutures dissolve on their own without intervention.  The non-
absorbable sutures will be removed at the subject’s two-week follow-up 
visit and disposed of at the practice site per standard of care.
7.4.6.5
Prior and Concomitant Therapy
Describe what prior and/or concomitant medical therapy will be collected. 
Describe which concomitant medicines/therapies are permitted during the 
study. Describe which concomitant medicines are not permitted during the 
study.
There will be no prior or concomitant medical or surgical therapy.
8.0
Number of Subjects and Statistical Plan
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8.1
Number of Subjects
Indicate the maximum number of subjects to be accrued/enrolled. Distinguish between the number of 
subjects who are expected to be enrolled and screened, and the number of subjects needed to 
complete the research procedures if applicable (i.e., numbers of subjects excluding screen failures.)
A maximum of 32 subjects, 16 in each group will be enrolled.  
8.2
Sample size determination
If applicable, provide a justification of the sample size outlined in section 8.1  to include reflections on, 
or calculations of, the power of the study.
Minimum sample size required to detect a difference in a normalized POSAS score of 1 between two 
groups is 16 subjects/group, at a standard deviation of 1 (power 80%, p-value <0.05).  Therefore, we 
plan to enroll a total of 32 subjects, 16 in each group.  
8.3
Statistical methods
Describe the statistical methods (or non-statistical methods of analysis) that will be employed.
We will utilize a trained statistician to conduct our statistical analysis.  We will likely use a paired T test 
for quantitative values and a Mann-Whitney U test for scaled values, though this will ultimately be 
determined by our statistician at time of analysis following data collection. 
9.0
Data and Safety Monitoring Plan
This section is required when research involves more than Minimal Risk to subjects as defined in “HRP-001 
SOP- Definitions.”
Minimal Risk is defined as the probability and magnitude of harm or discomfort anticipated in the research that 
are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of 
routine physical or psychological examinations or tests.  For research involving prisoners, Minimal Risk is the 
probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in 
the routine medical, dental, or psychological examination of healthy persons. 
Please complete the sections below if the research involves more than minimal risk to subjects, otherwise 
indicate each section as not applicable. 
[Do not type here]
9.1
Periodic evaluation of data
Describe the plan to periodically evaluate the data collected regarding both harms and benefits to 
determine whether subjects remain safe.
N/A 
9.2
Data that are reviewed
Describe the data that are reviewed, including safety data, untoward events, and efficacy data.
N/A
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9.3
Method of collection of safety information
Describe the method by which the safety information will be collected (e.g., with case report forms, at 
study visits, by telephone calls and with subjects).
N/A
9.4
Frequency of data collection
Describe the frequency of data collection, including when safety data collection starts.
N/A
9.5
Individuals reviewing the data
Identify the individuals who will review the data. The plan might include establishing a data and safety 
monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the 
sponsor.
N/A
9.6
Frequency of review of cumulative data
Describe the frequency or periodicity of review of cumulative data.
N/A
9.7
Statistical tests
Describe the statistical tests for analyzing the safety data to determine whether harms are occurring.
N/A
9.8
Suspension of research
Describe any conditions that trigger an immediate suspension of research.
N/A
10.0
Risks
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, a description of the 
probability, magnitude, duration and reversibility of the risks. Consider all types of risk including physical, 
psychological, social, legal, and economic risks.  Note: Loss of confidentiality is a potential risk when conducting 
human subject research.

If applicable, indicate which procedures may have risks to the subjects that are currently unforeseeable.

If applicable, indicate which procedures may have risks to an embryo or fetus should the subject be or 
become pregnant.

If applicable, describe risks to others who are not subjects.

Loss of confidentiality will be minimized as the research team will only have access to the research data 
and all information will be kept on a password-protected computer or in a locked filing cabinet.
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
Subjects will be assigned to a treatment program by chance. The treatment received may prove to be 
less effective or to have more side effects than the other research treatment(s) or other available 
treatments.

Risks related to the laceration repair, independent of the study, include hematoma, infection, and 
wound healing issues including wound breakdown or dehiscence.  

Non-absorbable suture risks:  Adverse reactions associated with the nylon suture material include wound 
dehiscence, gradual loss of tensile strength over time, calculi formation in urinary and biliary tracts when 
prolonged contact with salt solutions such as urine and bile occurs, infection, minimal acute inflammatory 
tissue reaction, and transitory local irritation at the wound site. Broken needles may result in extended or 
additional surgeries or residual foreign bodies. Inadvertent needle sticks with contaminated surgical needles 
may result in transmission of bloodborne pathogens.

Absorbable suture risks:  Adverse reactions of the plain and chromic suture material include wound 
dehiscence, calculi formation in urinary and/or biliary tracts and prolonged contact with salt solutions such 
as urine and bile occurs, and transitory local irritation at the wound site.  Patients with allergy or 
hypersensitivity to collagen or chromium may experience reactions resulting in inflammation, tissue 
granulation, fibrosis, wound suppuration, bleeding, sinus formation, secondary infection or inflammatory 
response characteristic of foreign body response.
This suture may have variable rates of absorption over time (depending on such factors as the type of 
suture used, the presence of infection, and the tissue site).  This may result in failure to provide adequate 
wound support in closure of sites where expansion, stretching or distension etc. may occur, unless 
additional support is supplied through the use of nonabsorbable suture material.  Failure to provide 
adequate wound support in elderly, malnourished, or debilitated patents or in patients suffering from 
cancer, anemia, obesity, infection or other conditions may delay wound healing.
11.0
Potential Benefits to Subjects and Others 
11.1
Potential Benefits to Subjects
Describe the potential benefits that individual subjects may experience from taking part in the research. 
If there is no direct benefit to subjects, indicate as such. Compensation is not considered a benefit. 
Compensation should be addressed in section 13.0.
There is no direct benefit to subjects.  
11.2
Potential Benefits to Others
Include benefits to society or others. 
Data gathered from this study could help providers determine the best suture material for their patients 
and reduce complications of suture repairs. 
12.0
Sharing Results with Subjects
Describe whether results (study results or individual subject results, such as results of investigational diagnostic 
tests, genetic tests, or incidental findings) will be shared with subjects or others (e.g., the subject’s primary care 
physicians) and if so, describe how information will be shared. 
N/A
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13.0
Subject Payment and/or Travel Reimbursements
Describe the amount, type (cash, check, gift card, other) and timing of any subject payment or travel 
reimbursement. If there is no subject payment or travel reimbursement, indicate as not applicable. 
Extra or Course Credit:  Describe the amount of credit and the available alternatives. Alternatives should be 
equal in time and effort to the amount of course or extra credit offered. It is not acceptable to indicate that the 
amount of credit is to be determined or at the discretion of the instructor of the course. 
Approved Subject Pool: Indicate which approved subject pool will be used; include in response below that 
course credit will be given and alternatives will be offered as per the approved subject pool procedures. 
Each study participant will be paid $25.00 upon completion of the study.  This will be payable at their final 12-
week follow-up visit in the form of a Greenphire debit card.  
14.0
Economic Burden to Subjects
14.1
Costs
Describe any costs that subjects may be responsible for because of participation in the research.
The research related tests and procedures that will be provided at no cost include:

Patient and Observer Scar Assessment Scale (POSAS)

Visual Analog Scale (VAS)
14.2
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.
If there is no sponsor agreement that addresses compensation for medical care for research subjects 
with a research-related injury, include the following text as written - DO NOT ALTER OR DELETE:
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Costs for the treatment of research-related injuries 
will be charged to subjects or their insurance carriers. 
For sponsored research studies with a research agreement with the sponsor that addresses 
compensation for medical care for research-related injuries, include the following text as written - DO 
NOT ALTER OR DELETE:
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Such charges may be paid by the study sponsor as 
outlined in the research agreement and explained in the consent form.
N/A
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15.0
Resources Available 
15.1
Facilities and locations
Identify and describe the facilities, sites and locations where recruitment and study procedures will be 
performed. 
If research will be conducted outside the United States, describe site-specific regulations or customs 
affecting the research, and describe the process for obtaining local ethical review. Also, describe the 
principal investigator’s experience conducting research at these locations and familiarity with local 
culture.
Penn State Health Milton S. Hershey Medical Center
15.2
Feasibility of recruiting the required number of subjects
Indicate the number of potential subjects to which the study team has access.  Indicate the percentage 
of those potential subjects needed for recruitment.
The study team has access to all patients with hand and forearm lacerations who come through the 
Penn State Health Hershey Emergency Department requiring hand surgery consultation who meet 
inclusion criteria.  It is unknown the exact percentage of those patients needed for recruitment as the 
number who come into the Emergency Department in which hand surgery is consulted is variable. 
15.3
PI Time devoted to conducting the research
Describe how the PI will ensure that a sufficient amount of time will be devoted to conducting and 
completing the research. Please consider outside responsibilities as well as other on-going research for 
which the PI is responsible.
Sufficient time will be devoted to conducting the research and reviewing the data.
15.4
Availability of medical or psychological resources
Describe the availability of medical or psychological resources that subjects might need as a result of 
their participation in the study, if applicable.
Penn State Health Milton S. Hershey Medical Center
15.5
Process for informing Study Team
Describe the training plans to ensure members of the research team are informed about the protocol 
and their duties, if applicable.
All team members are provided copies of all IRB approved documents – protocol, data collection tools, 
approval memos, etc.  Updates are provided regularly.
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16.0
Other Approvals
16.1
Other Approvals from External Entities
Describe any approvals that will be obtained prior to commencing the research (e.g., from engaged 
cooperating institutions IRBs who are also reviewing the research and other required review 
committees, community leaders, schools, research locations where research is to be conducted by the 
Penn State investigator, funding agencies, etc.).
N/A
16.2
Internal PSU Committee Approvals
Check all that apply:
  Anatomic Pathology – Penn State Health only – Research involves the collection of tissues or use of 
pathologic specimens. Upload a copy of “HRP-902 - Human Tissue For Research Form” in CATS IRB. 
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA 
or gene therapy).
  Clinical Laboratories – Penn State Health only – Collection, processing and/or storage of extra tubes 
of body fluid specimens for research purposes by the Clinical Laboratories; and/or use of body fluids 
that had been collected for clinical purposes but are no longer needed for clinical use. Upload a copy 
of “HRP-901 - Human Body Fluids for Research Form” in CATS IRB. 
  Clinical Research Center (CRC) Advisory Committee – All campuses – Research involves the use of 
CRC services in any way.
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest.
  Radiation Safety – Penn State Health only – Research involves research-related radiation 
procedures. All research involving radiation procedures (standard of care and/or research-related) 
must upload a copy of “HRP-903 - Radiation Review Form” in CATS IRB. 
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE.
  Scientific Review – Penn State Health only – All investigator-written research studies requiring 
review by the convened IRB must provide documentation of scientific review with the IRB 
submission. The scientific review requirement may be fulfilled by one of the following: (1) external 
peer-review process; (2) department/institute scientific review committee; or (3) scientific review by 
the Clinical Research Center Advisory committee.  NOTE: Review by the Penn State Health Cancer 
Institute (PSCI) Protocol Review Committee or the PSCI Disease Team is required if the study 
involves cancer prevention studies or cancer patients, records and/or tissues. For more information 
about this requirement see the IRB website.
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  St. Joseph Administrative Review – Penn State Health only – Penn State Health Research that will be 
conducted at St. Joseph Medical Center or St. Joseph Community Medical Groups. 
17.0
Multi-Site Study
If this is a multi-site study (i.e., a study in which two or more institutions coordinate, with each institution 
completing all research activities outlined in a specific protocol) and the Penn State PI is the lead investigator, 
describe the processes to ensure communication among sites in the sections below.
[Do not type here]
17.1
Other sites 
List the name and location of all other participating sites. Provide the name, qualifications and contact 
information for the principal investigator at each site and indicate which IRB will be reviewing the study 
at each site.
N/A
17.2
Communication Plans
Describe the plan for regular communication between the overall study director and the other sites to 
ensure that all sites have the most current version of the protocol, consent document, etc.  Describe the 
process to ensure all modifications have been communicated to sites. Describe the process to ensure 
that all required approvals have been obtained at each site (including approval by the site’s IRB of 
record).   Describe the process for communication of problems with the research, interim results and 
closure of the study.
N/A
17.3
Data Submission and Security Plan
Describe the process and schedule for data submission and provide the data security plan for data 
collected from other sites.  Describe the process to ensure all engaged participating sites will safeguard 
data as required by local information security policies.
N/A
17.4
Subject Enrollment
Describe the procedures for coordination of subject enrollment and randomization for the overall 
project.
N/A
17.5
Reporting of Adverse Events and New Information
Describe how adverse events and other information will be reported from the clinical sites to the overall 
study director. Provide the timeframe for this reporting.
N/A
17.6
Audit and Monitoring Plans
Describe the process to ensure all local site investigators conduct the study appropriately. Describe any 
on-site auditing and monitoring plans for the study.
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N/A
18.0
Adverse Event Reporting
18.1
Adverse Event Definitions
For device studies, incorporate the following definitions into the below responses, as written:
Unanticipated 
adverse device 
effect
Any serious adverse effect on health or safety or any life-threatening problem 
or death caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence 
in the investigational plan or IDE application (including a supplementary plan 
or application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects.
18.2
Recording of Adverse Events
Address the frequency and process for eliciting adverse event information from research subject, e.g., 
“Research subjects will be routinely questioned about adverse events at study visits.”
In the response, incorporate the following as written:
All adverse events (serious or non-serious) and abnormal test findings observed or reported to study 
team believed to be associated with the study drug(s) or device(s) will be followed until the event (or 
its sequelae) or the abnormal test finding resolves or stabilizes at a level acceptable to the 
investigator.
An abnormal test finding will be classified as an adverse event if one or more of the following criteria 
are met:

The test finding is accompanied by clinical symptoms

The test finding necessitates additional diagnostic evaluation(s) or medical/surgical 
intervention; including significant additional concomitant drug treatment or other therapy
NOTE: Simply repeating a test finding, in the absence of any of the other listed criteria, does 
not constitute an adverse event.

The test finding leads to a change in study drug dosing or discontinuation of subject 
participation in the clinical research study

The test finding is considered an adverse event by the investigator.
All adverse events (serious or non-serious) and abnormal test findings observed or reported to study 
team believed to be associated with the study drug(s) or device(s) will be followed until the event (or its 
sequelae) or the abnormal test finding resolves or stabilizes at a level acceptable to the investigator.
An abnormal test finding will be classified as an adverse event if one or more of the following criteria are 
met:

The test finding is accompanied by clinical symptoms

The test finding necessitates additional diagnostic evaluation(s) or medical/surgical intervention; 
including significant additional concomitant drug treatment or other therapy
NOTE: Simply repeating a test finding, in the absence of any of the other listed criteria, does not 
constitute an adverse event.

The test finding leads to a change in study drug dosing or discontinuation of subject 
participation in the clinical research study

The test finding is considered an adverse event by the investigator.
18.3
Causality and Severity Assessments
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE: 
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The investigator will promptly review documented adverse events and abnormal test findings to 
determine 1) if the abnormal test finding should be classified as an adverse event; 2) if there is a 
reasonable possibility that the adverse event was caused by the study drug(s) or device(s); and 3) if the 
adverse event meets the criteria for a serious adverse event.
If the investigator’s final determination of causality is “unknown and of questionable relationship to the 
study drug(s) or device(s)”, the adverse event will be classified as associated with the use of the study 
drug(s) or device(s) for reporting purposes.  If the investigator’s final determination of causality is 
“unknown but not related to the study drug(s) or device(s)”, this determination and the rationale for the 
determination will be documented in the respective subject’s case history.
18.4
Reporting of Adverse Reactions and Unanticipated Problems to the FDA  
18.4.1 Written IND/IDE Safety Reports
For a drug study under an IND, incorporate the following from 21 CFR 312.32 as written – DO 
NOT ALTER OR DELETE: 
The Sponsor-Investigator will submit a written IND Safety Report (i.e., completed FDA Form 
3500A) to the responsible new drug review division of the FDA for any observed or volunteered 
adverse event that is determined to be a serious and unexpected, suspected adverse reaction.  
Each IND Safety Report will be prominently labeled, “IND Safety Report”, and a copy will be 
provided to all participating investigators (if applicable) and sub-investigators.
Written IND Safety Reports will be submitted to the FDA as soon as possible and, in no event, 
later than 15 calendar days following the Sponsor-Investigator’s receipt of the respective 
adverse event information and determination that it meets the respective criteria for reporting.
For each written IND Safety Report, the Sponsor-Investigator will identify all previously 
submitted IND Safety Reports that addressed a similar suspected adverse reaction experience 
and will provide an analysis of the significance of newly reported, suspected adverse reaction in 
light of the previous, similar report(s) or any other relevant information.
Relevant follow-up information to an IND Safety Report will be submitted to the applicable 
review division of the FDA as soon as the information is available and will be identified as such 
(i.e., “Follow-up IND Safety Report”).
If the results of the Sponsor-Investigator’s follow-up investigation show that an adverse event 
that was initially determined to not require a written IND Safety Report does, in fact, meet the 
requirements for reporting; the Sponsor-Investigator will submit a written IND Safety Report as 
soon as possible, but in no event later than 15 calendar days, after the determination was made.
For a device study under an IDE, incorporate the following from 21 CFR 812.150 as written – 
DO NOT ALTER OR DELETE: 
The Sponsor-Investigator will submit a completed FDA Form 3500Ato the FDA’s Center for 
Devices and Radiological Health for any observed or volunteered adverse effect that is 
determined to be an unanticipated adverse device effect.  A copy of this completed form will be 
provided to all participating sub-investigators.
The completed FDA Form 3500Awill be submitted to the FDA as soon as possible and, in no 
event, later than 10 working days after the Sponsor-Investigator first receives notice of the 
adverse effect.
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If the results of the Sponsor-Investigator’s follow-up evaluation show that an adverse effect that 
was initially determined to not constitute an unanticipated adverse device effect does, in fact, 
meet the requirements for reporting; the Sponsor-Investigator will submit a completed FDA 
Form 3500Aas soon as possible, but in no event later than 10 working days, after the 
determination was made.
For each submitted FDA Form 3500A, the Sponsor-Investigator will identify all previously 
submitted reports that that addressed a similar adverse effect experience and will provide an 
analysis of the significance of newly reported adverse effect in light of the previous, similar 
report(s). 
Subsequent to the initial submission of a completed FDA Form 3500A, the Sponsor-Investigator 
will submit additional information concerning the reported adverse effect as requested by the 
FDA.
N/A
18.4.2 Telephoned IND Safety Reports – Fatal or Life-threatening Suspected Adverse Reactions
For a drug study under an IND, incorporate the following from 21 CFR 312.32 into the 
response, as written:
In addition to the subsequent submission of a written IND Safety Report (i.e., completed FDA 
Form 3500A), the Sponsor-Investigator will notify the responsible review division of the FDA by 
telephone or facsimile transmission of any unexpected, fatal or life-threatening suspected 
adverse reaction. 
The telephone or facsimile transmission of applicable IND Safety Reports will be made as soon 
as possible but in no event later than 7 calendar days after the Sponsor-Investigator’s receipt of 
the respective adverse event information and determination that it meets the respective criteria 
for reporting.
N/A
18.5
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE: 
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) 
experienced by a subject or other individual, which in the opinion of the investigator is determined to be 
(1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures.
18.6
Unblinding Procedures
Describe the procedures for unblinding study therapy on a subject, including documentation of this in 
the subject’s source document. Include example(s) here why someone might unblind a study. In most 
cases, the unblinding will be part of managing a serious adverse reaction and will be reported with the 
serious adverse event. However, in cases where unblinding was not associated with a serious adverse 
event, such actions should be reported in a timely manner.
Unblinding should be rare as subjects will be treated per standard of care practices.  Subject unblinding 
would only occur if the single observer needed to evaluate the wound prior to suture removal.  This 
would likely only occur between the ED visit and 2-week follow-up visit.  However, a non-study team 
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clinical provider will likely remove any sutures, if necessary, prior to the single observer assessing the 
wound.  If unblinding occurs, it will be documented in the subject’s source document.  The subject will 
not be withdrawn from the study.
18.7
Stopping Rules
In studies with a primary safety endpoint or studies with high risk to study subjects, provide the rules 
that define the circumstances and procedures for interrupting or stopping the study. If an independent 
Data and Safety Monitoring (DSMB) or Committee (DSMC) is set up for the study, the same stopping 
rules should be incorporated into the safety analysis plan as well.
There will be no stopping rules in this study, as both suture materials are FDA approved and safe for 
patient use.
If a subject, at any point in the study, demonstrates adverse reactions to the suture material, they will 
be treated accordingly.  Subjects in the absorbable suture material group will be treated with an 
antihistamine.  Subjects in the non-absorbable suture material group will have their sutures removed 
and treated with an antihistamine if needed.  These subjects will not be removed from the study, but 
will be included in a subgroup analysis. 
19.0
Study Monitoring, Auditing and Inspecting
19.1
Auditing and Inspecting
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE: 
The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 
documents (e.g., source documents, regulatory documents, data collection instruments, study data 
etc.).  The investigator will ensure the capability for inspections of applicable study-related facilities 
(e.g., pharmacy, diagnostic laboratory, etc.).
20.0
Future Undetermined Research: Data and Specimen Banking
If this study is collecting identifiable data and/or specimens that will be banked for future undetermined 
research, please describe this process in the sections below.  This information should not conflict with 
information provided in section 22 regarding whether or not data and/or specimens will be associated with 
identifiers (directly or indirectly).  If NOT applicable, indicate as such below in all sections.
[Do not type here]
20.1
Data and/or specimens being stored
Identify what data and/or specimens will be stored and the data associated with each specimen.
N/A
20.2
Location of storage
Identify the location where the data and/or specimens will be stored.
N/A
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20.3
Duration of storage
Identify how long the data and/or specimens will be stored. If data and/or specimens will be stored 
indefinitely, indicate as such. 
N/A
20.4
Access to data and/or specimens
Identify who will have access to the data and/or specimens.
N/A
20.5
Procedures to release data or specimens
Describe the procedures to release the data and/or specimens, including: the process to request a 
release, approvals required for release, who can obtain data and/or specimens, and the data to be 
provided with the specimens.
N/A
20.6
Process for returning results
Describe the process for returning results about the use of the data and/or specimens.
N/A
21.0
References
List relevant references in the literature which highlight methods, controversies, and study outcomes.
1.
Draaijers, L., Tempelman, F., Botman, Y., Tuinebreijer, W., Middelkoop, E., Kreis, R. and van Zuijlen, P., 2004. 
The Patient and Observer Scar Assessment Scale: A Reliable and Feasible Tool for Scar Evaluation. Plastic and 
Reconstructive Surgery, 113(7), pp.1960-1965.
2.
Shetty, P., Dicksheet, S. and Scalea, T., 1997. Emergency department repair of hand lacerations using 
absorbable vicryl sutures. The Journal of Emergency Medicine, 15(5), pp.673-674.
3.
KHARWADKAR, N., NAIQUE, S. and MOLITOR, P., 2005. Prospective Randomized Trial Comparing Absorbable 
and Non-Absorbable Sutures in Open Carpal Tunnel Release. Journal of Hand Surgery, 30(1), pp.92-95.
4.
Menovsky, T., Bartels, R., van Lindert, E. and André Grotenhuis, J., 2004. SKIN CLOSURE IN CARPAL TUNNEL 
SURGERY: A PROSPECTIVE COMPARATIVE STUDY BETWEEN NYLON, POLYGLACTIN 910 AND STAINLESS STEEL 
SUTURES. Hand Surgery, 09(01), pp.35-38.
5.
EREL, E., PLEASANCE, P., AHMED, O. and HART, N., 2001. Absorbable Versus Non-Absorbable Suture in 
Carpal Tunnel Decompression. Journal of Hand Surgery, 26(2), pp.157-158.
6.
Bæk Hansen, T., Kirkeby, L., Fisker, H. and Larsen, K., 2009. Randomised controlled study of two different 
techniques of skin suture in endoscopic release of carpal tunnel. Scandinavian Journal of Plastic and 
Reconstructive Surgery and Hand Surgery, 43(6), pp.335-338.
7.
Theopold, C., Potter, S., Dempsey, M. and O’Shaughnessy, M., 2011. A randomised controlled trial of 
absorbable versus non-absorbable sutures for skin closure after open carpal tunnel release. Journal of Hand 
Surgery (European Volume), 37(4), pp.350-353.
8.
Onyekwelu, I., Yakkanti, R., Protzer, L., Pinkston, C., Tucker, C. and Seligson, D., 2017. Surgical Wound 
Classification and Surgical Site Infections in the Orthopaedic Patient. JAAOS: Global Research and Reviews, 
1(3), p.e022.
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22.0
Confidentiality, Privacy and Data Management 
IMPORTANT: The following section is required for all locations EXCEPT Penn State Health and the College of 
Medicine.  Penn State Health and College of Medicine should skip this section and complete “HRP-598 
Research Data Plan Review Form.” In order to avoid redundancy, for this section state “See the Research Data 
Plan Review Form” if you are conducting Penn State Health research. Delete all other sub-sections of section 
22.
For research being conducted at Penn State Health or by Penn State Health researchers only: The research 
data security and integrity plan is submitted using “HRP-598 – Research Data Plan Review Form.”  
Refer to Penn State College of Medicine IRB’s “Standard Operating Procedure Addendum: Security and 
Integrity of Human Research Data,” which is available on the IRB’s website. In order to avoid redundancy, for 
this section state “See the Research Data Plan Review Form” if you are conducting Penn State Health 
research. Delete all sub-sections of section 22. 
For all other research: complete the following section.  Please refer to PSU Policy AD95 for information 
regarding information classification and security standards and requirements.  It is recommended that you work 
with local IT staff when planning to store, process, or access data electronically to ensure that your plan can be 
carried out locally and meets applicable requirements.   If you have questions about Penn State’s Policy AD95 or 
standards or need a consultation regarding data security, please contact security@psu.edu. 
See the Research Data Plan Review Form 
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