Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions
Phase: NA
Conditions: Surgical Incision
Sponsor: Wake Forest University Health Sciences

Secondary versus Tertiary Wound Closure in High Risk  
Gynecologic Abdominal Surgical Incisions 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 04418 
ClinicalTrials.gov:  NCT03861065 
 
 
 
Principal Investigator: 
 
Michael G. Kelly, M.D. 
Department of Obstetrics and Gynecology 
Wake Forest University School of Medicine 
Medical Center Blvd 
Winston-Salem, NC 27157 
 
 
 
Samuel Lentz, M.D. 
Department of Obstetrics and Gynecology  
Section of Gynecology Oncology 
Wake Forest University School of Medicine 
Medical Center Blvd 
Winston-Salem, NC 27157 
 
 
Co-Investigator(s):  
 
Janelle Beth Pakish, M.D. 
Department of Obstetrics and Gynecology 
Wake Forest University School of Medicine 
Medical Center Blvd 
Winston-Salem, NC 27157 
 
David I. Shalowitz, M.D., MSHP 
Department of Obstetrics and Gynecology  
Section of Gynecology Oncology 
Wake Forest Baptist Medical Center 
Wake Forest University School of Medicine 
Medical Center Blvd 
Winston-Salem, NC 27157 
 
 
Biostatistician: 
 
 
Fang-Chi Hsu, Ph.D. 
Wake Forest Baptist Comprehensive Cancer Center 
Wake Forest School of Medicine 
Medical Center Blvd 
Winston-Salem, NC 27157 
 
 
 
 

Secondary versus Tertiary Wound Closure in High Risk  
Gynecologic Abdominal Surgical Incisions 
Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) 
WFBCCC # 04418 
ClinicalTrials.gov:  NCT03861065 
 
 
 
Research Nurse:  
 
Sunshine Ann Poerio 
Wake Forest Baptist Comprehensive Cancer Center 
Wake Forest School of Medicine 
Medical Center Blvd 
Winston-Salem, NC 27157 
 
 
Regulatory Contact: 
 
Cindy Miller 
Wake Forest Baptist Comprehensive Cancer Center 
Wake Forest School of Medicine 
Medical Center Blvd 
Winston-Salem, NC 27157 
 
Protocol Editor: 
 
 
Mac Robinson, Ph.D. 
Wake Forest Baptist Comprehensive Cancer Center 
Wake Forest University School of Medicine 
Medical Center Blvd 
Winston-Salem, NC 27157 
 
 
Participating Institution(s): 
Wake Forest Baptist Medical Center 
 
 
Version Date: 
12-13-18 
Amended: 
 
02-18-19 
 
 
 
9-22-2019 
Confidential

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Gynecologic Abdominal Surgical Incisions 
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Table of Contents 
1.0 
Introduction and Background .......................................................................................... 5 
2.0 
Objectives ...................................................................................................................... 9 
2.1 
Primary Objective ....................................................................................................... 9 
2.2 
Secondary Objective................................................................................................... 9 
3.0 
Study Population ...........................................................................................................10 
3.1 
Inclusion Criteria ........................................................................................................10 
3.2 
Exclusion Criteria .......................................................................................................10 
3.3 
Inclusion of Women and minorities ............................................................................10 
4.0 
Methods ........................................................................................................................10 
4.1 
Registration Procedures ............................................................................................10 
4.2 
Study Activities Table ................................................................................................12 
4.3 
Experimental Methods ...............................................................................................12 
5.0 
Outcome Measures .......................................................................................................13 
5.1 
Primary Outcomes .....................................................................................................13 
5.2 
Secondary Outcomes ................................................................................................13 
6.0 
Analytic Plan..................................................................................................................14 
6.1 
Sample Size and Power ............................................................................................14 
6.2 
Interim Analysis .........................................................................................................14 
6.3 
Analysis of Primary Outcome .....................................................................................14 
6.4 
Analysis of Secondary Outcomes ..............................................................................14 
6.5 
Accrual Rate ..............................................................................................................15 
6.6 
Length of Study .........................................................................................................15 
7.0 
Data Management .........................................................................................................15 
8.0 
Confidentiality and Privacy ............................................................................................15 
9.0 
Data Safety and Monitoring ...........................................................................................15 
10.0 
Adverse Events List and Reporting Requirements .........................................................16 
10.1 
Adverse Event List for Tertiary Closure......................................................................16 
10.2 
Adverse Event Characteristics ...................................................................................16 
10.3 
STRC SAE Reporting Requirements .........................................................................17 
10.4 
WFUHS IRB AE Reporting Requirements .................................................................17 

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11.0 
Reporting of Unanticipated Problems, Adverse Events or Deviations ............................18 
Appendix A – Subject Eligibility Checklist ..................................................................................20 
Appendix B – Protocol Registration Form ..................................................................................21 
Appendix C – Mandatory STRC SAE Reporting Guidelines ......................................................22 
Appendix D – Baseline Data Collection Form ............................................................................29 
Appendix E – Surgery Form ......................................................................................................31 
Appendix F - Wound Form ........................................................................................................32 
Appendix G - Quality of Life (SF-36) .........................................................................................33 
Appendix H – Adverse Event Log .............................................................................................36 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 
Introduction and Background 
 
The Centers for Disease Control (CDC) estimates 1.9% of the estimated 16 
million surgical procedures each year in the United States are complicated by a 
surgical site infection (SSI).  The overall incidence of SSI with hysterectomy is 
between 1-2 %.[1,2]   
 
Surgical site infections are classified as follows: 
 
 
A 2011 study of postoperative surgical patients (general and vascular surgery) 
identified that and SSI resulted in $10,000 of excess hospital costs and 
prolonged hospital stay. [3]  In endometrial cancer patients,  SSIs accounted 
for a $5447 median increase in the 30-day cost of care.[4] A recent article in 
AJOG 2017 noted SSI rates of 2% associated with hysterectomy with an added 
cost of $5000 per case. [5]  Approximately 2/3 of gynecologic SSI are 
superficial incisional infections.[6]  
 
The Centers for Disease Control developed a Surgical Wound Classification 
system as outlined.  This designed as a risk model for (SSI).  As noted with an 
increase in the class there is an increase in the potential for infection. 
 
 

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Specifically related to gynecologic surgery, hysterectomy would be a clean 
contaminated or class II wound.  Gross spillage from the gastrointestinal tract 
would be considered a contaminated or class III wound.  A perforated viscus or 
abscess requiring surgery would be considered a dirty/infected or class IV 
wound.  Prophylactic antibiotics are indicated for class II and III wounds; 
therapeutic antibiotics are necessary for class IV wounds. 
 

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Within the group of class II wounds (hysterectomy), there are a subset of patients 
in which there are factors that increase the risk of SSI above baseline.  These 
include: 
a. Hyperglycemia, 
b. Smoking, 
c. Obesity (BMI > 30),  
d. Depth of subcutaneous tissue > 3 cm, 
e. Coexistent infection at a remote body site, 
f. Vaginal colonization (bacterial vaginosis), 
g. ASA status > 2, 
h. Immunodeficiency (chronic steroids, chemotherapy), and 
i. MRSA. 
Numerous measures have been proved and/or recommended to decrease 
postoperative infection. 
 
1.  Preoperative Measures 
a. Treat remote infections 
b. Clippers if shaving needed 
c. Serum glucose control < 200 mg/dl 
d. Antimicrobial bath/shower 
e. Chlorhexidine abdominal/vaginal prep (70%/4%) 
f. Antibiotic prophylaxis 
 
2. Intraoperative Measures 
a. Surgical technique  
b. Preventing hypothermia 
c. Appropriate re-dosing of prophylactic antibiotics 
d. Prevention of dead space and incisional seromas 
 
Wound management techniques after fascial closure to address reduction in 
incisional infections especially in high risk class II and class III/IV wounds have 
included the following: 
 
• Primary closure with subcutaneous drains and possibly incisional 
vacuum assisted closure device (VAC) for 3-4 days, 
• Secondary closure with wound packing and dressing changes 2-3 
times daily or VAC placement with changes 2-3 times weekly, and 
• Tertiary or delayed primary closure. 
 

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The vacuum–assisted closure (VAC) as noted above involves placement of a 
sterile sponge with negative continuous pressure proven to remove tissue fluid, 
increase blood supple and stimulate the wound thus decreasing time to healing. 
[6,7] 
 
Also, ETHICON has developed suture impregnated with TRICLOSAN as an 
antimicrobial proven to reduce some surgically related infections.  
• CDC Guidelines for the Prevention of Surgical Site Infections 2017 
o Consider the use if triclosan-coated sutures for the prevention of 
SSI. [8] 
• WHO Global Guidelines for The Prevention of Surgical Site Infection 
o The panel suggests the use of triclosan coated sutures for the 
purpose of reducing the risk of SSI, independent of type of 
surgery. [9]  
• American College of Surgeons Surgical Infection Society 
• The use of triclosan coated suture is recommended for wound closure 
in clean and clean contaminated cases when available. [10] 
Abstract 
Introduction 
Surgical site infections (SSI) following gynecological abdominal surgeries are 
associated with prolonged wound healing, additional procedural costs and a lower 
quality of life. The purpose of this study is to describe an alternative wound closure 

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technique (tertiary closure) aimed at improving wound morbidity for high-risk patients 
compared to healing by secondary intention. 
 
Methods 
Patients undergoing surgery at high-risk (class III or III wound) for developing SSI were 
enrolled. Tertiary closure was performed by: 1) running a subcuticular absorbable 
monofilament suture with looping of the suture every 8-10 cm through the skin secured 
with hemoclips and by 2) placing a vacuum assisted closure (VAC) over the incision. On 
post-operative day four (POD #4), the incision was re-approximated at the bedside by 
removing the VAC and applying traction on the suture using hemoclips.  
 
Results 
Six consecutive patients undergoing gynecologic abdominal surgery had tertiary 
closure. The mean patient age and BMI were 51 and 28, respectively. Two patients had 
surgery for benign conditions and four for malignancy. Two of the six wounds were 
class IV (abscess) and the other four wounds were class III (GI contamination). The 
mean operative duration was 5.5 hours and the median length of stay was 4 days. At 
sixty days, no SSI or other wound complications were identified.  
 
Conclusions 
Tertiary closure of high-risk gynecological abdominal wounds is safe and feasible. 
Based on this data, we have designed a larger trial comparing outcomes of tertiary 
closure to secondary closure for high-risk patients undergoing gynecologic abdominal 
surgery. 
2.0 
Objectives 
2.1 
Primary Objective 
2.1.1 To compare the percentage of patients whose  wound remained 
closed on postoperative day #30 after tertiary closure compared to 
historical controls who underwent secondary would closure.  We 
are primarily looking at time to wound closure.  We will be able to 
abstract this information from the postoperative clinic visit 
notes from patients in the "historical control" cohort.  We will identify 
20 patients with characteristics described in the inclusion criteria of 
this study who underwent laparotomy with secondary would closure 
during the calendar year 2018. 
 
2.2 
Secondary Objective 
2.2.1 To compare the proportion of acute and chronic wound infection in 
wounds closed with a tertiary closure technique to historical 
controls receiving a secondary wound closure. 
 

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2.2.2 To compare the length of stay of patients receiving a tertiary wound 
closure to historical controls receiving a secondary wound closure. 
 
2.2.3 To describe the number of patients receiving a tertiary wound 
closure that return within 30 days of surgery as compared to 
historical controls receiving a secondary wound closure.  
 
2.2.4 To describe the quality of life in patients receiving a tertiary wound 
closure. 
3.0 
Study Population 
3.1 
Inclusion Criteria 
3.1.1 Patients with high risk class II, class III, class IV abdominal wounds 
 
3.1.2 Undergoing laparotomy for gynecologic related disorders 
 
Patients undergoing laparotomy for both benign and malignant diagnoses 
will be included in this study  
3.2 
Exclusion Criteria   
3.2.1 Pregnancy 
 
3.2.2 Allergy to triclosan 
 
3.2.3 Patients undergoing HIPEC 
3.3 
Inclusion of Women and minorities 
3.3.1 Women of all races and ethnicity who meet the above-described 
eligibility criteria are eligible for this trial.  
 
3.3.2 The study consent form will also be provided in Spanish for 
Spanish-speaking participants. Based on WFBCCC population 
estimates, we expect approximately 25% Black or African American 
(N=5) and 10% of individuals to be combination of American 
Indian/Alaska Native, Asian and Hispanic/Latina ancestry. Should 
we not meet or exceed these estimates, the PI will engage the 
Cancer Center Health Equity Advisory Group to discuss strategies 
to enhance recruitment in these target populations. 
4.0 
Methods 
4.1 
Registration Procedures 
All patients entered on any WFBCCC trial, whether treatment, companion, 
or cancer control trial, must be linked with a study protocol in EPIC within 
24 hours of Informed Consent. Patients must be registered prior to the 
initiation of the study.   

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You must perform the following steps in order to ensure prompt 
registration of your patient: 
 
1.0 
Complete the Eligibility Checklist (Appendix A) 
2.0 
Complete the Protocol Registration Form (Appendix B) 
3.0 
Alert the Cancer Center registrar by phone, and then send the 
signed Informed Consent Form, Eligibility Checklist and Protocol 
Registration Form to the registrar, either by fax or e-mail. 
 
Contact Information: 
Protocol Registrar PHONE (336) 713-6767 
Protocol Registrar FAX (336) 713-6772 
Protocol Registrar E-MAIL (registra@wakehealth.edu) 
            
*Protocol Registration is open from 8:30 AM - 4:00 PM, Monday-
Friday. 
 
4.0 
Fax/e-mail ALL eligibility source documents with registration. 
Patients will not be registered without all required supporting 
documents. 
Note: If labs were performed at an outside institution, provide a printout of 
the results. Ensure that the most recent lab values are sent. 
 
To complete the registration process, the Registrar will:   
 
• assign a patient study number 
• register the patient on the study 
 
 
 

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4.2 
Study Activities Table 
 
 
 
 
Pre- 
Study 
 
At 
Surgery 
 
2 weeks 
post-
surgery (+/- 
5 days) 
 
4 weeks 
post-surgery 
(+/- 5 days) 
 
3-month 
Follow-up 
(+/- 5 
days) 
 
Informed consent 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Medical history 
• 
Surgical 
History 
X 
 
 
 
 
Concurrent meds 
X 
 
 
 
 
Physical exam 
X 
 
 
 
X 
Vital signs 
X 
 
 
 
X 
Wound Characteristics 
• 
Wound Class 
• 
Wound Depth 
• 
Wound Size 
 
 
X 
 
 
 
 
Duration of Surgery 
X 
X 
 
 
 
Wound Assessment 
 
 
X 
X 
X 
Quality of life (SF-36) 
X 
 
X 
X 
X 
CBC w/diff, platelets 
X 
 
 
 
 
Comprehensive 
Metabolic Panel 
X 
 
 
 
 
B-HCG (urine or serum) 
X 
 
 
 
 
Adverse event 
evaluation 
 
 
X 
X 
X 
X 
4.3 
Experimental Methods 
4.3.1 Patients will undergo standard of care surgery.  
4.3.2 Study Group: 
4.3.2.1 
High risk clean contaminated wounds (class II) as 
defined with one of the following: 
4.3.2.1.1 Obesity (BMI ≥ 30)  
4.3.2.1.2 Subcutaneous depth ≥ 4 cm  
4.3.2.1.3 ASA class ≥ 2 
4.3.2.1.4 Duration of surgery (from surgery to closure) > 180 
min 
4.3.2.2 
Contaminated wounds (class III) 
4.3.2.3 
Dirty/infected wounds (class IV) 
 
4.3.3 Closure Technique: 
Tertiary closure would involve the following: 
• Fascial closure with PDS Plus 
• Possible subcutaneous tissue approximation with Monocryl Plus 
at the surgeon’s discretion 
• Placement of a running subcuticular skin suture using an 
absorbable monofilament material such as PDS or Monocryl 
Plus without skin approximation 
• Placement of a vacuum-assisted closure device over the 
incision at 125 mm Hg 

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• On Day # 4-7 (surgeon’s discretion) at the bedside using sterile 
technique remove the VAC and approximate the skin edges 
using the previously placed subcuticular suture by pulling the 
suture ends and placing a hemoclip on the suture ends.  
• Sutures would not require removal 
 
4.3.4 Patient Follow-up and Data Collection 
4.3.4.1 
After surgery, the removal of the VAC and closing of the 
superficial aspects of the wound will be performed based 
on the physician’s discretion.  
4.3.4.2 
Patients will be monitored per standard of care 
procedures to assess infection, wound dehiscence, and 
wound complications. 
4.3.4.3 
Wound closure will be noted. 
4.3.4.4 
When the patient is discharged the time will be noted.  
5.0 
Outcome Measures 
5.1 
Primary Outcomes 
5.1.1 The percentage of patients whose wound is closed on 
postoperative day # 30 after tertiary wound closurecompared to 
historical controls who underwent secondary would closure. 
5.2 
Secondary Outcomes 
5.2.1 The proportion of SSI using a tertiary closure technique compared 
to historical controls receiving a secondary would closure. 
 
5.2.2 The length of stay as defined by the time from surgery to discharge 
as compared to historical controls receiving a secondary would 
closure. 
 
5.2.3 The proportion of patients that return within 30 days of surgery.  
 
5.2.4 The quality of life in patients receiving a tertiary wound closure. 
It is expected that tertiary closure will be superior to secondary 
closure.  The time to closure with the tertiary approach should be 
much shorter.  It is unknown if wounds closed in a tertiary manner 
will remain closed.  That was our rationale for choosing wound 
closure at 30 days as the primary endpoint.  Differences in quality 
of life between the two approaches are also unknown. We 
have submitted an abstract from a chart review of 5 patients who 
have undergone tertiary closure.  We are looking to expand this 
cohort of patients to generate more quantitative data. 

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6.0 
Analytic Plan 
6.1 
Sample Size and Power 
Twenty patients with a tertiary closure will be recruited (experimental 
group). The proportion of wound closure within 30 days for these patients 
will be compared to the proportion from 100 historical controls receiving a 
secondary wound closure. We anticipate closer to 100% of wound closure 
in the experimental group and closer to 0% of wound closure in the control 
group.  Assuming the significance level at 0.05 and a two-sided test, we 
have greater than 90% power to claim that the proportions of wound 
closure within 30 days are different between the two groups. 
6.2 
Interim Analysis 
6.2.1 After five patients an interim analysis will be performed to assess 
safety outcome of the trial. If all five patients are unhealthy the 
protocol will be suspended until independent review of outcomes. 
(an unhealthy patient is one with either a wound or systemic 
infection.  A wound infection is an incision with skin 
erythema, purulent drainage, nonviable or necrotic subcutaneous 
tissue or a positive wound culture.  Systemic infection is defined as 
a SIRS response with additional evidence of wound infection as the 
most likely source of the systemic infection). Amendments or 
closure will be made per the recommendation. 
6.3 
Analysis of Primary Outcome 
The chi-squared test will be used to compare the proportions of wound 
closure within 30 days between the experimental group (i.e., patients 
receiving a tertiary wound closure) and the historical control group (i.e., 
patients receiving a secondary wound closure).  Logistic regression 
models will be used when confounding variables such as age will be 
adjusted.  Wound closure status is the outcome measure.  Experimental 
group is the covariate of interest.   
6.4 
Analysis of Secondary Outcomes 
6.4.1 The analysis approach for comparing the proportion of acute and 
chronic wound infection between the two groups is the same as that 
specified in 6.3. 
6.4.2 The distribution of length of stay will be examined and transformed if 
needed.  To compare the length of stay between the two groups, the 
2-sample t-test will be used if the length of stay is normally 
distributed and the Wilxocon rank sum test will be used if it is not 
normally distributed. To adjust for confounding variables, a linear 
regression model will be used if the length of stay is normally 
distributed and a negative binomial model will be used if it is not 
normally distributed. 

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6.4.3 The analysis approach for comparing the proportion of patients that 
return within 30 days of surgery between the two groups is the same 
as that specified in 6.3. 
6.4.4 Descriptive statistics, including mean, standard deviation, median, 
and interquartile range, will be calculated to describe the quality of 
life in patients receiving a tertiary wound closure,   
6.5 
Accrual Rate 
6.5.1 Twenty in one year (approximately two per month) 
6.6 
Length of Study 
6.6.1 The approximate length of the study will be one year. 
7.0 
Data Management 
 
Informed consent document 
EPIC 
Protocol registration form (Appendix B) 
WISER/OnCore 
Baseline Data Collection (Appendix D) 
WISER/OnCore 
Surgery Form (Appendix E) 
WISER/OnCore 
Wound Form (Appendix F) 
WISER/OnCore 
30-Day Follow-up Form (Appendix G) 
WISER/OnCore 
Quality of Life (SF-36) (Appendix H) 
WISER/OnCore  
Adverse Events Log (Appendix I) 
WISER/OnCore 
8.0 
Confidentiality and Privacy 
 
Confidentiality will be protected by collecting only information needed to assess 
study outcomes, minimizing to the fullest extent possible the collection of any 
information that could directly identify subjects, and maintaining all study 
information in a secure manner. To help ensure subject privacy and 
confidentiality, only a unique study identifier will appear on the data collection 
form. Any collected patient identifying information corresponding to the unique 
study identifier will be maintained on a linkage file, store separately from the 
data. The linkage file will be kept secure, with access limited to designated study 
personnel. Following data collection, subject identifying information will be 
destroyed six years after closure of the study, by deleting the linkage files 
consistent with data validation and study design, producing an anonymous 
analytical data set. Data access will be limited to study staff. Data and records 
will be kept locked and secured, with any computer data password protected. No 
reference to any individual participant will appear in reports, presentations, or 
publications that may arise from the study. 
9.0 
Data Safety and Monitoring 
The principal investigator will be responsible for the overall monitoring of the data 
and safety of study participants. The principal investigator will be assisted by 
other members of the study staff. 

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10.0 Adverse Events List and Reporting Requirements 
 
10.1 Adverse Event List for Tertiary Closure 
10.1.1 Infection 
As a result of enrollment onto this trial, there is a risk of developing a 
wound infection.  This infection could be minor (skin redness).  A wound 
infection could also involve the deeper tissues underneath the skin.  It that 
occurs, the incision is typically re-opened and the deeper tissues are 
cleaned, irrigated and packed with a dressing.  Rarely, a serious wound 
infection causes you to develop a fever or generalized 
infection.  Treatment of a more serious wound infection could involve the 
following:  re-admission to the hospital, intravenous antibiotics or 
additional surgery. 
 
Enrolled patients will be at medium to high risk for wound complications in general.  Wound 
complications usually occur within the first 30 days of surgery.  Incisional hernia is a more 
"long-term" complication of a surgical wound.  This complication can occur up to 1 year after 
surgery.  Enrolled patients will be monitored carefully for wound complications using our 
standard care approach for patients with medium to high risk for wound complications. 
10.2 Adverse Event Characteristics 
 
• 
CTCAE term (AE description) and grade:  The descriptions and grading 
scales found in the revised NCI Common Terminology Criteria for Adverse 
Events (CTCAE) version 4.0 will be utilized for AE reporting. All appropriate 
treatment areas should have access to a copy of the CTCAE version 4.0. A 
copy of the CTCAE version 4.0 can be downloaded from the CTEP web site 
(http://ctep.cancer.gov). 
• 
‘Expectedness’: AEs can be ‘Unexpected’ or ‘Expected’ (see Section 7.1 
above) for expedited reporting purposes only.   
 
• 
Attribution of the AE: 
 
- 
Definite – The AE is clearly related to the study treatment. 
- 
Probable – The AE is likely related to the study treatment. 
- 
Possible – The AE may be related to the study treatment. 
- 
Unlikely – The AE is doubtfully related to the study treatment. 
- 
Unrelated – The AE is clearly NOT related to the study treatment. 
 
 
 

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10.3 STRC SAE Reporting Requirements 
 
The Safety and Toxicity Reporting Committee (STRC) is responsible for 
reviewing SAEs for WFBCCC Institutional studies as outlined in Appendix C. 
STRC currently requires that all unexpected 4 and all grade 5 SAEs on these 
trials be reported to them for review. All WFBCCC Clinical Protocol and Data 
Management (CPDM) staff members assisting a Principal Investigator in 
investigating, documenting and reporting an SAE qualifying for STRC reporting 
are responsible for informing a clinical member of the STRC as well as the entire 
committee via the email notification procedure of the occurrence of an SAE.  
10.4 WFUHS IRB AE Reporting Requirements 
 
Any unanticipated problems involving risks to subjects or others and adverse 
events shall be promptly reported to the IRB, according to institutional policy. 
Reporting to the IRB is required regardless of the funding source, study sponsor, 
or whether the event involves an investigational or marketed drug, biologic or 
device. Reportable events are not limited to physical injury, but include 
psychological, economic and social harm. Reportable events may arise as a 
result of drugs, biological agents, devices, procedures or other interventions, or 
as a result of questionnaires, surveys, observations or other interactions with 
research subjects. 
 
All members of the research team are responsible for the appropriate reporting to 
the IRB and other applicable parties of unanticipated problems involving risk to 
subjects or others. The Principal Investigator, however, is ultimately responsible 
for ensuring the prompt reporting of unanticipated problems involving risk to 
subjects or others to the IRB. The Principal Investigator is also responsible for 
ensuring that all reported unanticipated risks to subjects and others which they 
receive are reviewed to determine whether the report represents a change in the 
risks and/or benefits to study participants, and whether any changes in the 
informed consent, protocol or other study-related documents are required. 
 
Any unanticipated problems involving risks to subjects or others occurring at a 
site where the study has been approved by the WFUHS IRB (internal events) 
must be reported to the WFUHS IRB within 7 calendar days of the investigator or 
other members of the study team becoming aware of the event. 
 
Any unanticipated problems involving risks to subjects or others occurring at 
another site conducting the same study that has been approved by the WFUHS 
IRB (external events) must be reported to the WFUHS IRB within 7 calendar 
days of the investigator or other members of the study team becoming aware of 
the event. 
 
Any event, incident, experience, or outcome that alters the risk versus potential 
benefit of the research and as a result warrants a substantive change in the 
research protocol or informed consent process/document in order to insure the 
safety, rights or welfare of research subjects. 

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11.0 Reporting of Unanticipated Problems, Adverse Events or 
Deviations 
Any unanticipated problems, deviations or protocol changes will be promptly 
reported by the principal investigator or designated member of the research team 
to the IRB and sponsor or appropriate government agency if appropriate.

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References 
 
1. Wick EC, Hicks C, Bosk CL (2013) Surgical site infection monitoring: are 2 systems 
better than 1? JAMA Surg 148 (12):1085-1086. doi:10.1001/jamasurg.2013.3020 
2. Letourneau AR, Calderwood MS, Huang SS, Bratzler DW, Ma A, Yokoe DS (2013) 
Harnessing claims to improve detection of surgical site infections following 
hysterectomy and colorectal surgery. Infect Control Hosp Epidemiol 34 (12):1321-1323. 
doi:10.1086/673975 
3. Boltz MM, Hollenbeak CS, Julian KG, Ortenzi G, Dillon PW (2011) Hospital costs 
associated with surgical site infections in general and vascular surgery patients. Surgery 
150 (5):934-942. doi:10.1016/j.surg.2011.04.006 
4. Bakkum-Gamez JN, Dowdy SC, Borah BJ, Haas LR, Mariani A, Martin JR, Weaver 
AL, McGree ME, Cliby WA, Podratz KC (2013) Predictors and costs of surgical site 
infections in patients with endometrial cancer. Gynecol Oncol 130 (1):100-106. 
doi:10.1016/j.ygyno.2013.03.022 
5. Steiner HL, Strand EA (2017) Surgical-site infection in gynecologic surgery: 
pathophysiology and prevention. Am J Obstet Gynecol 217 (2):121-128. 
doi:10.1016/j.ajog.2017.02.014 
6. Lazenby GB, Soper DE (2010) Prevention, diagnosis, and treatment of gynecologic 
surgical site infections. Obstet Gynecol Clin North Am 37 (3):379-386. 
doi:10.1016/j.ogc.2010.05.001 
7. Wilkes RP, Kilpad DV, Zhao Y, Kazala R, McNulty A (2012) Closed incision 
management with negative pressure wound therapy (CIM): biomechanics. Surg Innov 
19 (1):67-75. doi:10.1177/1553350611414920 
8. Masden D, Goldstein J, Endara M, Xu K, Steinberg J, Attinger C (2012) Negative 
pressure wound therapy for at-risk surgical closures in patients with multiple 
comorbidities: a prospective randomized controlled study. Ann Surg 255 (6):1043-1047. 
doi:10.1097/SLA.0b013e3182501bae 
9. Rogers SO, Jr. (2017) Surgical Perspective: Centers for Disease Control and 
Prevention Guideline for the Prevention of Surgical Site Infection 2017. Surg Infect 
(Larchmt) 18 (4):383-384. doi:10.1089/sur.2017.097 
10. (2016). In:  Global Guidelines for the Prevention of Surgical Site Infection. WHO 
Guidelines Approved by the Guidelines Review Committee. Geneva,  
 
 
 
 

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Appendix A – Subject Eligibility Checklist 
 
 
IRB Protocol No.  00055298  
Protocol No CCCWFU 04418 
Study Title: Secondary versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical 
Incisions 
Principal Investigator:  Michael G. Kelly, M.D. 
Inclusion Criteria 
(as outlined in study protocol) 
Criteria 
is met 
Criteria 
is NOT 
met 
Source Used to Confirm * 
(Please document dates and lab 
results) 
Patients with high risk class II, 
class III, class IV abdominal 
wounds 
□ 
□ 
 
Undergoing laparotomy for 
gynecologic related disorders 
□ 
□ 
 
Patients undergoing laparotomy 
for both benign and malignant 
diagnoses will be included in this 
study 
□ 
□ 
 
Exclusion Criteria 
(as outlined in study protocol) 
Criteria 
NOT 
present 
Criteria 
is 
present 
Source Used to Confirm * 
(Please document dates and lab 
results) 
Pregnancy 
□ 
□ 
 
Allergy to triclosan 
□ 
□ 
 
Patients undergoing HIPEC 
□ 
□ 
 
 
This subject is      
 eligible /  ineligible     for participation in this study. 
 
OnCore Assigned PID: ___ ___ ___ ___ ___ ___ ___ ___  
 
 
 
 
Signature of research professional confirming eligibility: _______________________  
 
Date: ___ ___/___ ___/___ ___ 
 
Signature of Treating Physician**:  _____________________________________  
 
Date: ___ ___/___ ___/___ ___ 
 
 
* Examples of source documents include clinic note, pathology report, laboratory results, etc. When listing 
the source, specifically state which document in the medical record was used to assess eligibility. Also 
include the date on the document. Example: “Pathology report, 01/01/14” or “Clinic note, 01/01/14” 
 
**Principal Investigator signature can be obtained following registration if needed 

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Appendix B – Protocol Registration Form 
 
DEMOGRAPHICS 
Patient: Last Name: _____________________ First Name: ___________________________ 
MRN:          ___ ___ ___ ___ ___ ___ ___ ___ DOB (mm/dd/yy): ___ ___ / ___ ___ / ___ ___ 
ZIPCODE:  ___ ___ ___ ___ ___ 
 
 
SEX:   
  Male      Female 
Ethnicity (choose one):   Hispanic 
Non-Hispanic 
Race (choose all that 
apply): 
 WHITE           BLACK            ASIAN 
 PACIFIC ISLANDER                 NATIVE AMERICAN 
Height:   ___ ___.___ inches 
Weight: ___ ___ ___.___lbs.(actual) 
Surface Area: ___ ___.___m2   
 
Primary Diagnosis: ____________________________________________________________ 
Date of Diagnosis: ___ ___ /___ ___/___ ___ 
 
Performance Status: ___ ___ ___    ECOG   
Protocol Registrar can be contact by calling 336-713-6767 between 8:30 AM and 4:00 PM, Monday – Friday. 
 
Completed Eligibility Checklist and Protocol Registration Form must be hand delivered, faxed or e-mailed to 
the registrar at 336-7136772 or registra@wakehealth.edu. 
 
PROTOCOL INFORMATION 
Date of Registration: 
___ ___ / ___ ___ / ___ ___ 
MD Name (last) : 
______________________       
Informed written consent: 
(consent must be signed prior to 
registration) 
 YES  NO 
 
Date Consent Signed: 
___ ___ / ___ ___ / ___ ___ 
 
PID # (to be assigned by OnCore): 
___ ___ ___ ___ ___ ___ ___ ___ 
 

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Appendix C – Mandatory STRC SAE Reporting Guidelines 
 
 
 
 
 
Mandatory STRC SAE Reporting Requirements in WISER 
This document describes reporting requirements of adverse events from WFBCCC 
Investigator Initiated interventional trials to the Safety and Toxicity Review Committee 
(STRC). A trial is considered a WFBCCC Investigator Initiated interventional trial if the 
following criteria are met: 
 
1) The Principal Investigator (PI) of the trial is a member of a department at the 
Wake Forest University Baptist Medical Center. 
2) WFBCCC is considered as the primary contributor to the design, implementation 
and/or monitoring of the trial. 
3) The trial is designated as “Interventional” using the Clinical Research 
Categories definitions provided by the NCI in the Data Table 4 
documentation. 
(https://cancercenters.cancer.gov/GrantsFunding/DataGuide#dt4) 
 
There are two distinct types of WFBCCC Investigator Initiated interventional trials based 
on where patient enrollment occurs.  These include: 
 
1) Local WFBCCC Investigator Initiated interventional trials defined as trials where all 
patients are enrolled from one of the WFBCCC sites. These include the main 
outpatient Cancer Center clinics (located in Winston-Salem) as well as WFBCCC 
affiliate sites located in Bermuda Run (Davie Medical Center), Clemmons, 
Lexington, High Point, or Wilkesboro. 
2) Multi-Center WFBCCC Investigator Initiated interventional trials defined as trials 
where patients are enrolled from other sites in addition to WFBCCC sites.   
There are three types of trials that are included in this category: 
a. Trials sponsored by the NCI Community Oncology Research Program 
(NCORP) that are conducted at multiple sites where the PI is a member of a 
department at the Wake Forest University Baptist Medical Center. 
b. Trials sponsored by Industry that are conducted at multiple sites and the 
PI is a member of a department at the Wake Forest University Baptist 
Medical Center. 
c. Trials sponsored by WFBCCC that are conducted at multiple sites and the 
PI is a member of a department at the Wake Forest University Baptist 
Medical Center. 
Safety and Toxicity Review Committee (STRC; 
previously known as CROC)  Serious Adverse 
Event (SAE) Notification SOP 
     Date: 07/10/2019 
 

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All Adverse Events (AEs) and Serious Adverse Events (SAEs) that occur on any patients 
enrolled on WFBCCC Investigator Initiated Interventional trials must be entered into the 
WISER system. The only exception to this requirement is for patients enrolled on NCORP 
trials at non- WFBCCC sites. AEs and SAEs for NCORP patients enrolled at WFBCCC sites 
must be entered into the WISER system. Once these AEs and SAEs are entered in WISER, 
certain actions must be taken regarding the reporting of specific Adverse Events to the 
STRC. 
All Adverse Events that occur during protocol intervention (defined below) and are coded as 
either 1) unexpected grade 4, 2) unplanned inpatient hospitalization > 24 hours (regardless 
of grade), or grade 5 (death) must be reported to the STRC using the using the SAE console in 
WISER. 
 
A research nurse or clinical research coordinator when made aware that an adverse event 
meets one of the above criteria has occurred on a WFBCCC Investigator Initiated 
interventional trial, is responsible for informing a clinical member of the STRC by phone (or 
in-person) about the adverse event. The nurse/coordinator should contact the treating 
physician prior to calling the STRC clinical member to obtain all details of the SAE, as well as 
all associated toxicities to be recorded along with the SAE. In addition, this nurse or 
coordinator is responsible for entering the adverse event information into the SAE console in 
WISER.  Once the adverse event has been entered into the SAE console an email informing 
the entire STRC committee will be generated. 
 
THESE REPORTING REQUIREMENTS APPLY TO any staff member on the study team for a 
WFBCCC Institutional Interventional trial. Ultimately, the protocol PI has the primary 
responsibility for AE identification, documentation, grading and assignment of attribution to 
the investigational agent/intervention. However, when an AE event as described above is 
observed, it is the responsibility of the person who observed the event to be sure that it is 
reported to the STRC. 
 
What is considered during protocol intervention? 
During protocol intervention is considered to be the time period while a patient is on study 
treatment or during the time period within 30 days of last study treatment (even if patient 
begins a new (non-study) treatment during the 30 days). This window of 30 days should be 
the standard window to be used in all protocols unless a specific scientific rationale is 
presented to suggest that a shorter window can be used to identify events. If it is a trial 
sponsored by Industry and the sponsor requires a longer window for monitoring of SAEs, 
then the longer window of time specified by the sponsor should be followed. 
 
What is considered as an Unexpected Grade 4 event? 
Any grade 4 event that was not specifically listed as an expected adverse event in the 
protocol should be considered as unexpected. A grade 4 adverse event can be considered to 
be unexpected if it is an event that would not be expected based on the treatment being 

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received or if it is unexpected based on the health of the patient. In either case, if there is 
any uncertainty about whether a grade 4 adverse event is expected or unexpected it should 
be reported to STRC. 
 
STRC notification responsibilities of the person (e.g., nurse) handling the 
reporting/documenting of the SAE in WISER: 
1. Make a phone call (or speak in person) to the appropriate clinical member of the 
STRC as listed below (page if necessary) 
2. Enter a new SAE into the SAE module that is located in the Subject>> CRA Console in 
WISER WITHIN 24 HOURS of first knowledge of the event. Information can be 
entered and saved, but the STRC members will not be notified until a date is 
entered into the STRC Notification Date Field. This will ensure that all persons that 
need to be made aware of the event (i.e., study team members and STRC members) 
will be notified; remember to file a copy of the confirmation. 
3. Document that the appropriate person(s) on the STRC has been contacted. Indicate 
the name of the STRC clinician that was contacted in the Event Narrative field in the 
SAE console of the particular subject. 
4. Document whether or not the protocol should be suspended based on the 
discussion with the STRC clinician. This is the major function of the email 
notification. Enter whether the protocol should be suspended in the Event Narrative 
Field. 
5. Follow up/update the clinical member(s) of STRC regarding any new developments or 
information obtained during the course of the SAE investigation and reporting 
process. 
 
Elements needed to complete the SAE form in the Subject Console in WISER (see Screen Shot 
3): 
1. Event Date 
2. Reported Date 
3. Reported by 
4. If Grade 5, enter Death Date 
5. If Grade 5, enter Death occurred: within 30 days 
6. Event Narrative: Brief description (include brief clinical history relevant to this event, 
including therapies believed related to event). Begin narrative with the STRC clinician 
who was notified and Date/Time notified. In addition, state attribution by STRC 
clinician as either “Unrelated”, “Unlikely”, “Possibly”, “Probably”, or “Definitely”.  
Always include the following here: 
i. STRC clinician name and comments 
ii. Date of last dose before the event 
iii. Is suspension of the protocol needed? Y/N 
7. Treating Physician comments 
8. PI comments, if available 
9. Protocol Attribution after discussion with STRC clinician 

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10. Outcome (Fatal/Died, Intervention for AE Continues, Migrated AE, Not Recovered/Not 
Resolved, Recovered/Resolved with Sequelae, Recovered/Resolved without Sequelae, 
Recovering and Resolving) 
11. Consent form Change Required? Y/N 
12. SAE Classification *This is required in order for the email notification to be sent* 
13. Adverse Event Details – Enter all details for each AE associated with the SAE. 
a. Course start date 
b. Category 
c. AE Detail 
d. Comments 
e. Grade/Severity 
f. Unexpected Y/N 
g. DLT Y/N 
h. Attributions 
i. Action 
j. Therapy 
k. Click ADD to attach the AE Detail to the SAE. 
14. Enter Date Notified STRC -- *This is required for the email notification to be sent* 
15. Click Submit. The auto-generated notification email will disseminate within 5 minutes. 
If you do not receive an email within 5 minutes, check that you have entered the 
“Date Notified STRC” and the “SAE Classification”. If these have been entered and the 
email still has not been received, take a screen shot of the SAE in WISER and 
immediately email it out to all of the STRC members listed in this SOP. In the subject 
line, indicate that this is a manual transmission of the SAE in lieu of the auto-
generated email. It is required that a notification goes to the STRC members 
immediately so that their assessment can be obtained within the 24 hour time frame 
requirement. Contact the Cancer Center Programmer/Analyst to alert that there is an 
issue with the auto-generated email. 
 
The Clinical Members of STRC to Notify by Phone or Page: 
Bayard Powell, MD – Director-at-Large, WFBCCC; Section Head, 
Hematology/Oncology  
Glenn Lesser, MD – Hematology Oncology  
Stefan Grant, MD, JD-Hematology  
Jimmy Ruiz, MD-Hematology Oncology  
Mercedes Porosnicu, MD- Hematology Oncology  
         Michael Farris, MD – Radiation Oncology  
 
Definition of Unavailable: 
As a general guideline if the first clinician that is contacted does not respond to the phone 
call or page within 30 minutes, then initiate contact with a different STRC clinician. Allow up 
to 30 minutes for the new STRC clinician to respond to a phone call or page before contacting 
another member. These times (30 minutes) are a general guideline. Best judgment as a 

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clinical research professional should be used giving considerations of the time of day, 
severity of the SAE, and other circumstances as to when it is appropriate to contact backup 
clinicians. If the event occurs near the end of day, then leave messages (voice or email) as 
appropriate and proceed with submitting the STRC notification form. It is important to take 
reasonable steps and to document that some type of contact has been initiated to one or 
more of the clinical members of STRC. 
 
STRC CLINICAN RESPONSIBILITY: 
It is the responsibility of the STRC clinician to review all reported events, evaluate the events 
as they are reported; and communicate a response to the Investigator, event reporter and 
the members of STRC. The review will include but not be limited to the information reported; 
there may be times when additional information is needed in order for an assessment to be 
made and further communication directly with the investigator may be warranted. STRC 
reserves the right to disagree with the Investigator's assessment. If STRC does not agree with 
the Investigator, STRC reserves the right to suspend the trial pending further investigation. If 
there is any immediate danger or harm that could be present for a future patient based on 
the information provided in the STRC report then an immediate suspension of enrollment 
should be considered. 
 
AMENDMENTS TO PREVIOUS REPORTS 
If all pertinent information is unavailable with the initial submission, once the additional 
information is available do not submit a new report. Rather, go to the original email that 
was sent to the STRC and using that email “reply to all”. Entitle this new email “Amendment 
for (list date of event and patient ID)” this will avoid duplications of the same event. List the 
additional information being reported. This information needs to be entered into WISER as 
well. To do this, go to the Subject console and click SAEs on the left column. Click on the 
appropriate SAE number that needs updating. Then click update. This will allow additional 
information to be added 
 
Acronyms 
AE – Adverse Event 
STRC-Safety and Toxicity Review Committee 
SAE-Serious Adverse Event 
WFBCCC – Wake Forest Baptist Comprehensive Cancer Center 
NCI-National Cancer Institute 
WISER –Wake Integrated Solution for Enterprise Research 
Screen Shots: 
 
The following screen shots come from the SAE Console within the Subject Console in WISER. 
 
 
 

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Screen Shot 1: 
 
 
Screen Shot 2: 
 
 
 
 

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Screen Shot 3: 
 
 
Screen Shot 4: 
 
 
 
 
 

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Appendix D – Baseline Data Collection Form 
Instructions: Fill this form out to collect baseline data 
 
1. BMI: ___ ___ .___ 
 
2. ASA Class 
 II 
 III 
 IV 
 V 
 VI 
 
3. Medical Comorbidities 
 Acute Myocardial Infarction 
 History of Myocardial Infarction 
 Congestive Heart Failure 
 Peripheral Vascular Disease 
 Cerebrovascular Disease  
 Chronic Obstructive Pulmonary Disease (COPD) 
 Dementia 
 Paralysis (Hemiplegia or Paraplegia) 
 Diabetes 
 Diabetes with Complications 
 Renal Disease 
 Mild Liver Disease 
 Moderate/Severe Liver Disease 
 Peptic Ulcer Disease 
 Rheumatologic Disease 
 AIDS 
 
(Additional) 
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________ 
 
4. Surgical History 
 
a. Has the patient had previous surgery? 
 Yes    
 No 
b. If Yes, please describe: 
___________________________________________________________
___________________________________________________________
___________________________________________________________
___________________________________________________________ 

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5. Tobacco Use (Check all that apply): 
Smoking Status:  
 Current Every day smoker,  
 Current some day smoker,  
 Former smoker,  
 Heavy Tobacco smoker,  
 Light Tobacco smoker,  
 Never assessed,  
 Never Smoker,  
 Passive smoke exposure- 
 Never smoker,  
 Smoker-current status unknown,  
 Unknown if ever smoked 
 
Start date (mm/dd/yyyy): ___ ___/___ ___/___ ___ ___ ___ 
 
Quit date (mm/dd/yyyy): ___ ___/___ ___/___ ___ ___ ___ 
 
Types (Check all that apply):  
 Cigarettes,  
 Pipe,  
 Cigars,  
 E-cig/Vapor w/nicotine,  
 E-cig/Vapor w/o 
 
Pack/Day: __ 
 
Years: ___ ___ 
 
Smokeless Tobacco: 
 Current user, 
 Former user, 
 Never used, 
 
Unknown 
 
Types: 
 Snuff, 
 Chew 
 
Quit date (mm/dd/yyyy): ___ ___/___ ___/___ ___ ___ ___ 
 
Comment: 
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________ 
 
 

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Appendix E – Surgery Form 
Instructions: Use this form to fill out relevant surgery information 
 
1. Date of Surgery (mm/dd/yyyy): ___ ___/___ ___/___ ___ ___ ___ 
 
2. Wound Measurements 
a. Subcutaneous depth: _ ___ ___ cm 
b. Length: ___ ___ .___ cm 
c. Width: ___ ___.___ cm 
 
3. Procedure 
a. Colon bundle used? 
 Yes 
No 
b. Antibiotic use: 
 Yes 
No 
i. If Yes, name type, dose and frequency:  
ii. Type: _______________________________________ 
iii. Dose: _______________________________________ 
iv. Frequency: __________________________________ 
c. Is the antibiotic type appropriate?  
 Yes 
No 
 
4. Length of Surgery 
 
a. Surgery Start Time (hh:mm): ___ ___:___ ___  
 
b. Surgery Stop (hh:mm): ___ ___:___ ___  
 
c. Time total time (hh:mm): ___ ___:___ ___ 
 
5. Wound Class 
 II  
 
 III 
  
 IV 
6. Intraoperative Complications (free text): 
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________ 
 
 
 
 
 
 
 

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Appendix F - Wound Form 
 
Visit: 
 2 weeks 
 4 weeks 
 3 months 
 
Date of encounter (mm/dd/yyyy): ___ ___/___ ___/___ ___ ___ ___   
 
1. Infection: 
 Yes    
 No 
If yes, date infection occurred: (mm/dd/yyyy): ___ ___/___ ___/___ ___ ___ ___ 
 
2. Did Wound Dehiscence occur? 
 Yes    
 No 
If yes, date: (mm/dd/yyyy): ___ ___/___ ___/___ ___ ___ ___ 
Physician’s assessment of why dehiscence occurred: 
________________________________________________________________
________________________________________________________________
________________________________________________________________
________________________________________________________________ 
 
3.  Percentage of wound healing:  _________% 
 
4. Day of hospital discharge (mm/dd/yyyy): ___ ___/___ ___/___ ___ ___ ___ 
 
5. Post-surgery date wound is closed  
(mm/dd/yyyy): ___ ___/___ ___/___ ___ ___ ___ 
 
6. Is the wound closed on POD # 30? 
 Yes    
 No  
 
7. Wound Complications (free text): 
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________
___________________________________________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Appendix G - Quality of Life (SF-36) 
Instructions: Have the patient compete this evaluation at baseline, 2, 4, 6 and at 3 
months follow-up 
 
Standard Form – 36 (SF-36) 
OnCore PID: 
Date: 
Standard Form 36 Survey:  The SF-36 Form is one of many outcomes assessments designed by 
the Medical Outcomes Trust in Boston, MA.  It is designed to approximate the improvement in 
health status from a medical intervention. 
 
INSTRUCTIONS: 
This survey asks for views about your health.  This information will help 
keep track of how you feel and how well you are able to do your usual daily activities.  Answer 
every question marking the answer as indicated.  If you are unsure about how to answer a 
question, please give the best answer you can. 
1. In general, would you say your health is: 
(Circle One) 
 
1. Excellent 
2. Very Good 
3. Good 
4. Fair 
5. Poor 
 
2. Compared to one year ago, how would 
you rate your health in general at this 
time? (Circle One) 
1. Much better now than one year ago 
2. Somewhat better now than one year ago 
3. About the same as one year ago 
4. Somewhat worse that one year ago  
5. Much worse now than one year ago 
3.  The following items are about activities you might do during a typical day.  Does your health 
now limit you in these activities?  If so, how much?    (Circle the appropriate number for 
each question) 
Activities 
Yes, limited  
a lot 
Yes, limited 
a little 
No, not 
limited 
a. Vigorous activities, such as running, lifting 
heavy objects, or participation in strenuous 
sports 
1 
2 
3 
b. Moderate activities, such as moving a table, 
Vacuuming, bowling or golfing 
 
1 
2 
3 
c. Lifting or carrying groceries 
1 
2 
3 
d. Climbing several flights of stairs 
1 
2 
3 
e. Climbing one flight of stairs 
1 
2 
3 
f. Bending, kneeling, or stooping 
1 
2 
3 
g. Walking more than a mile 
1 
2 
3 

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h. Walking several blocks 
1 
2 
3 
i. Walking one block 
1 
2 
3 
j. Bathing or dressing yourself 
1 
2 
3 
4.  During the past 4 weeks, have you had any of the following problems with your work or other 
regular activities as a result of your physical health? (Circle the appropriate number for each 
question) 
a. Cut down on the amount of time you spent on work 
or other activities 
Yes = 1 
No = 2 
b.   Accomplished less than you would like 
Yes = 1 
No = 2 
c.   Were limited in the kind of work or other activities 
Yes = 1 
No = 2 
d.  Had difficulty performing the work or other activities (For 
example – requiring an extra effort) 
Yes = 1 
No = 2 
 
5. During the past 4 weeks, have you had any of the following problems with your work or other 
regular daily activities as a result of any emotional problems (such as feeling depressed or 
anxious)? (Circle the appropriate number for each question) 
a. Cut down on the amount of time you spent on work or other 
activities 
Yes = 1 
No = 2 
b.   Accomplished less than you would like 
Yes = 1 
No = 2 
c.   Didn’t do work or other activities as carefully as usual 
Yes = 1 
No = 2 
 
6. During the past 4 weeks, to what extent has your physical health 
or emotional problems interfered with your normal social 
activities with family, friends, neighbors or groups? (Circle 
one) 
1. Not at all 
2. Slightly 
3. Moderately 
4. Quite a bit 
5. Extremely 
 
7. How much bodily pain have you had during the past 4 weeks?  
(Circle one) 
1. None 
2. Very mild 
3. Mild 
4. Moderate 
5. Severe 
6. Very severe 
 
8. During the past 4 weeks, how much did pain interfere with your 
normal work (including both work outside the home and 
housework)?  (Circle one) 
1. Not at all 
2. Slightly 
3. Moderately 
4.  Quite a bit 
5.  Extremely 

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9. These questions are about how you feel and how things have been with you during the past 4 
weeks.  For each question, please give the one answer that comes closest to the way you have been 
feeling.  How much of the time during the past 4 weeks: (Circle one number on each line) 
 
All of 
the 
time 
Most 
of the 
time 
A good 
bit of 
the time 
Some 
of the 
time 
A little 
of the 
time 
None of 
the time 
a. Did you feel full of pep? 
1 
2 
3 
4 
5 
6 
b. Have you been a very nervous 
person? 
1 
2 
3 
4 
5 
6 
c. Have you felt so down in the dumps 
that nothing could cheer you up? 
1 
2 
3 
4 
5 
6 
d. Have you felt calm and peaceful? 
1 
2 
3 
4 
5 
6 
e. Did you have a lot of energy? 
1 
2 
3 
4 
5 
6 
f. Have you felt downhearted and blue? 
1 
2 
3 
4 
5 
6 
g. Did you feel worn out? 
1 
2 
3 
4 
5 
6 
h. Have you been a happy person? 
1 
2 
3 
4 
5 
6 
i. Did you feel tired? 
1 
2 
3 
4 
5 
6 
 
10. During the past 4 weeks, how much of the time has your physical 
health or emotional problems interfered with your social activities 
(like visiting friends, relatives etc.)? (Circle one) 
1. All of the time 
2. Most of the time 
3. Some of the time 
4. A little of the time 
5. None of the time 
 
11. How TRUE or FALSE is each of the following statements to you? (Circle one for each line). 
 
Definitely 
True 
Mostly 
True 
Don’t 
Know 
Mostly 
False 
Definitely 
False 
a. I seem to get sick easier than other 
people 
1 
2 
3 
4 
5 
b. I am as healthy as anybody I know 
1 
2 
3 
4 
5 
c. I expect my health to get worse 
1 
2 
3 
4 
5 
d. My health is excellent 
1 
2 
3 
4 
5 
 
 

Secondary versus Tertiary Wound Closure in High Risk  
Gynecologic Abdominal Surgical Incisions 
CCCWFU # 04418 
 
Version Date 09/22/19                                                                                                                          Page 36 of 36 
Appendix H – Adverse Event Log 
 
WFBCCC Adverse Event (AE) Log 
PI: _________________   Subject PID: 
________________ 
MRN: ________________ 
Cycle #: _________            Cycle Start Date: ____________      Cycle Start Time: ___________         Cycle End Date: ____________           Cycle End Time: ____________                
Adver
se 
Event 
CTC 
Term 
Lab 
Valu
e 
Grad
e         
(1-5) 
per 
CTC 
Sta
rt 
Dat
e 
En
d 
Dat
e 
Attribution 
DEF=Definite 
PROB=Proba
ble 
POSS=Possi
ble 
UNLK=Unlikel
y 
UNRL=Unrela
ted 
Expect
ed 
N=No   
Y=Yes 
Serious 
Adverse Event 
Detail        
NO=No                 
LT=Life 
Threatening 
DTH=Death 
DIS=Disability 
HOS=Hospitaliz
ation           
CA=Caused 
congenital 
anomaly               
RI=Required 
intervention to 
prevent 
impairment  
Dose 
Limiti
ng 
Toxitit
y 
(DLT)     
N=No     
Y=Yes 
Action Taken 
NO=None          
DR=Dose 
Reduced 
RI=Regimen 
Interrupted        
TD=Therapy 
discontinued 
INTR=Interrup
ted then 
reduced 
Therapy Given   
NO=None  
SYM=Symptom
atic  SUP= 
Supportive    
VSUP=Vigorou
s supportive 
Reportabl
e?      
IRB-IRB       
STRC-
STRC          
FDA-FDA    
SPON-
Sponsor 
(Mark all 
that apply) 
Adver
se 
Event 
Report 
(AER) 
Filed      
N=No   
Y=Yes 
Outcome  
R=Recover
ed TX=Still 
under 
treatment/ 
observatio
n A=Alive 
with 
sequalae 
D=Died   
Treating 
MD 
Initials/D
ate 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
Serious Adverse Event: Hospitalization; Disability; Birth Defect; Life-threatening; Death. 
CTCAE Version 4 - http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf 
STRC- Safety and Toxicity Review Committee 
Version 1/10/18