A Randomized, Prospective, Double Blind Clinical Trial of Non-cross-linked Porcine Dermis vs. Bioabsorbable Synthetic Mesh for the Repair of Abdominal Wall Defects in At-risk Patients
Phase: NA
Conditions: Ventral Hernia
Sponsor: Wake Forest University Health Sciences

 
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RESEARCH PROTOCOL 
 
TITLE OF PROTOCOL: A Randomized, Prospective, Double Blind Clinical Trial of Non-Cross-
Linked Porcine Dermis vs. Bioabsorbable Synthetic Mesh for the Repair of Abdominal Wall 
Defects in At-Risk Patients 
 
PRIMARY INVESTIGATOR: 
B. Todd Heniford, MD 
Department of General Surgery 
Carolinas Specialty Surgery Center 
1025 Morehead Medical Drive, Suite 300 
Charlotte, NC 28204 
704-355-3168 
 
RESPONSIBLE DEPARTMENTAL CHAIRPERSON: 
Michael Thomason, MD 
Department of General Surgery 
Carolinas Medical Center 
1000 Blythe Blvd, MEB 601 
Charlotte, NC 28203 
704-355-3176 

 
 
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Summary 
 
We propose a randomized, prospective clinical trial to evaluate the use of non-cross-linked porcine 
dermis (Strattice®) versus bioabsorbable tissue reinforcement (Gore® Bio-A®) for repair of 
abdominal wall defects in grade II or III hernia patients according to Ventral Hernia Working Group 
(VHWG) classification 1. 
 
Purpose 
The goal of the proposed study is to evaluate the outcomes of patients implanted with Strattice® 
(LifeCell Corporation, Branchburg, NJ, USA) and Gore® Bio-A® (W. L. Gore & Associates, Inc., 
Newark, DE, USA) for the repair of abdominal wall defects in at-risk patients. Primary endpoints of 
the study will include hernia recurrence, duration of postoperative drains, the incidence of systemic 
and wound-related complications, the need for percutaneous intervention or reoperation and quality- 
of-life with 3 years of follow-up. The study will be prospective and randomized, and the evaluator 
and patient will be blinded as to the type of mesh implanted. 
 
Background and Significance 
Over 150,000 ventral and incisional hernia repairs are performed annually in the United States 2. 
Reinforcing the fascial closure with mesh has dramatically reduced recurrence rates by as much as 
50-70%. Synthetic mesh has been shown to provide durable long-term outcomes; however, its use is 
contraindicated in contaminated fields. Contaminated and dirty wounds include a spectrum of 
operations involving opening or anastomosis of the GI tract, reoperation at the sites of on-going or 
previous infection, fistula, or abscess, infected foreign body, and major break in sterile technique. If a 
permanent synthetic mesh is used under such circumstances, there is greater than 50% risk of 
developing subsequent infection or persistent draining sinus as the synthetic mesh can  harbor 
bacteria and prevent the host immune system from eradicating the infection even with adequate 
antibiotic treatment 3. In the majority of these cases (50-90%), the mesh has to be surgically excised 
to enable the wound to heal 4. 
 
To address the challenge of prosthetic reinforcement in contaminated fields, biologic grafts or meshes 
have been developed. Biologic mesh is made of an acellular collagen matrix derived from dermal, 
fascial, pericardial, or other tissues. Strattice® (LifeCell Corporation, Branchburg, NJ, USA) is a 
common biologic mesh originating from porcine dermal matrix. Biologic meshes allow the body to 
eradicate small amounts of bacterial contamination (up to 104 CFU/ml) by promoting tissue in-growth 
into the mesh collagen matrix. Porcine derived biologic meshes have been shown to clear bacterial 
infection with Staphylcoccus aureus. Strattice was demonstrated to be most effective among porcine 
meshes at lowering bacterial counts5 and has been shown to provide equivalent integrity and strength 
of hernia repair in animal models6. However, in the same animal models followed over longer 
periods of time, we have seen both animal and human derived biologic meshes lose their integrity 
and tensile strength when exposed to bacterial loads at the time of implantation7. The impact of this 
phenomenon has been documented in humans, but its clinical relevance and impact on long term 
results has not been tracked. 
 
In recent years, bioabsorbable, non-tissue derived products have been developed as an alternative to 
biologic mesh. Bioabsorbable mesh employs the same principals as biologic mesh by promoting tissue 

 
 
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in-growth and neovascularization but was developed to address the weaknesses of biologics. Bio-A® 
(W. L. Gore & Associates, Inc., Newark, DE, USA) is a bioabsorble mesh composed of 67% 
polyglycolic acid and 33% trimethylene carbonate commonly used in the reinforcement of soft tissue. 
Identical chemical composition is used in making some sutures and Seamguard®, a product used in 
the reinforcement of staple lines. These are inert materials, neither of which has been known to 
stimulate allergic reactions in human subjects. Bio-A is constructed as a non-woven web that acts as a 
scaffold for tissue in-growth and is absorbed in the body within approximately 6 months.8 
Furthermore, the use Bio-A offers healthcare providers and patients significant cost savings over 
biologics, as much as 66% per square centimeter.9 
 
Although our own animal studies (see below) have demonstrated improved tissue in-growth and 
collagen deposition with bioabsorbable mesh compared to biologic porcine-derived material, no 
randomized, prospective, blinded study comparing these two mesh types is available nor has there 
been long term follow-up which includes quality of life measures in humans. Therefore, we propose a 
randomized, prospective, blinded clinical trial of patients with grade II or III ventral hernias 
according to Ventral Hernia Working Group (VHWG) classification that will compare outcomes of 
Strattice versus Bio-A. Grade II hernias are those in patients with certain comorbidities (diabetes 
mellitus, immunosuppression, current tobacco use, COPD, or BMI>30) that have been associated with 
higher rates of wound infections. Grade III hernias are considered to be potentially contaminated 
due to previous wound infection, presence of intestinal stoma, or violation of gastrointestinal tract1. 
Grade IV hernias are those in contaminated fields (current mesh infection, septic dehiscence), and 
these hernias will be excluded from this study. 
 
An appropriate prospective, randomized, double-blind clinical trial comparing the outcomes of 
Strattice and Bio-A in patients who would benefit from them most is absolutely needed and will 
allow surgeons to contrast results in an effort to decide which material will improve the outcomes of 
their patients with complicated abdominal wall defects. 
 
Preliminary Data 
We have previously evaluated tissue in-growth, collagen deposition and vessel formation of Bio-A 
and Strattice in sterile fields in a rabbit model. Grafts were implanted subcutaneously and harvested 
at 7, 14, 60, 90 and 180 days. The results are shown below. 

 
 
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grade 
grade 
grade 
 
Graph 1. Total Cellular In-grow th 
 
6 
 
5 
4 
 
3 
 
2 
1 
 
0 
7 
14 
30 
60 
90 
180 
 
days 
 
 
 
 
BioA 
Strattice 
 
 
 
 
Graph 2. Collagen Deposition 
 
5 
 
4 
 
3 
BioA 
 
2 
Strattice 
 
1 
 
0 
7 
14 
30 
60 
90 
 
days 
 
 
 
 
Graph 3. Vessel Formation 
 
5 
 
4 
 
3 
BioA 
2 
Strattice 
 
1 
 
0 
7 
14 
30 
60 
90 
180 
 
days 
 
 
 
Bio-A exhibited a higher degree of cellular in-growth, neovascularization, and collagen deposition 
than Strattice; however, we would like to evaluate use of both of these mesh types in at-risk patients 
to determine if one mesh produces superior outcomes in comparison to the other. 

 
 
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Materials and Methods - Patient Enrollment: 
This is a prospective, randomized study. Study subjects will include patients classified as grade II and 
grade III according to VHWG classification scheduled for elective or non-emergent open ventral 
hernia repair. 
 
Patients will qualify for this study if they meet the following criteria: 
• 
Age 18 or older 
• 
Grade II or III ventral hernia according to VHWG classification system 
• 
Pre-operative informed consent is obtainable 
 
Patients will be excluded from the study if they meet the following criteria: 
• 
Return to the operating room within the next 1 year for additional open abdominal surgery 
is anticipated 
• 
Absence of fascial defect or fascial defect less than 3 cm in greatest dimension 
• 
Presence of previously placed mesh (synthetic or biologic) at the site of surgery, which will 
not be completely removed and will, in part or in whole, remain at the site of implantation 
of the study mesh 
• 
Concurrent placement of another mesh (synthetic or biologic) at the site where the study 
mesh is placed 
• 
Grade IV ventral hernia according to VHWG system 
• 
ASA1 score IV or above 
• 
Any disease or condition along with the surgeon's clinical judgment that contraindicates 
the use of either study mesh 
• 
Pregnancy 
• 
Use of more than one of the same study mesh is not an exclusion criterion in and of itself, 
so long as the type of mesh is selected according to the randomization protocol 
 
During pre-operative evaluation, patients will be informed about the details of the proposed study 
including the use of mesh, methods and possible risks of the procedure as well as possible side effects 
associated with the use of mesh. Implantation of either mesh product should not increase the risk of 
post-operative morbidity. The patients will be informed that the use of non-permanent mesh is 
clinically indicated in their condition and the determination to use a non-permanent mesh intra- 
operatively will be made entirely on clinical grounds and not based on the research protocol. If a 
non-permanent mesh is required (biologic or bioabsorbable), the randomization of the study will 
prescribe which type of mesh will be used. To date, there is no evidence to suggest that either one of 
the study meshes is superior or safer than the other. Patients willing to enroll must be able to give 
their informed consent to a research coordinator, which will include permission to collect data, 
distribute surveys and contact them after surgery for educational and research purposes. 
 
Patient Randomization: 
Randomization will be performed by a certified statistician using a computerized algorithm. Stratified 
randomization will be used based on the demographics, comorbidities and nature of any potential 
 
 
1 American Society of Anesthesiologists 

 
 
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contamination in order to maximize the likelihood of balanced groups. Patients will remain unaware 
of their group assignment or implanted mesh type throughout the duration of the trial. 
 
 
Peri-Operative Care: 
On the day of surgery, each patient will be randomized into one of two mesh groups. A group 
assignment letter in a sealed opaque envelope will be placed into patient’s chart. The chart will be 
marked with a sticker indentifying the patient as part of proposed clinical study. Prior to taking the 
patient back to the operating room, the circulating nurse will check that the patient is appropriately 
consented and understands he/she is enrolled in the study. Furthermore, the circulating nurse is 
responsible for ensuring that the sealed envelope is in the chart and has not been opened. Following 
patient transfer to the operating room and induction of anesthesia, the circulating nurse will perform 
a "time-out", where he/she reads the consent form and notifies the operating room that the patient is 
part of the proposed study. As part of the time-out, the circulating nurse will open the sealed 
envelope and announce the mesh assignment to the surgical team prior to incision. This will give 
sufficient time for the staff to locate all necessary materials. 
 
Materials: 
The study meshes: 
• Strattice® (LifeCell Corporation, Branchburg, NJ, USA) 
• Gore®Bio-A® (W. L. Gore & Associates, Inc., Newark, DE, USA) 
as well as adjunct fixation materials will be drawn from the Operating Room supply. A member of 
the research team will ensure adequate stock of both mesh types. The size of the mesh will be 
determined by the operating surgeon. Unless otherwise clinically indicated, surgeons will obtain at 
least a 5 cm mesh-fascial overlap for the hernia repair, except possibly at the pubis or xiphoid process. 
The mesh is to be secured to the fascia using Prolene™ Polypropylene Suture (Ethicon, Inc., 
Hamburg, Germany) size 0 or greater on a non-cutting needle. Alternatively, an equivalent size 
polypropylene monofilament suture may be used. If more than one piece of subject mesh is required, 
the pieces must be sewn together with a running 0 polypropylene suture with interrupted stitches of 
0 polypropylene every 1.5cm. The mesh pieces may be of different sizes, however, all pieces must be 
of the same material as per the group assignment. Use of more than one type of mesh will result in 
disqualification from the study. 
 
Procedure for Repair of Abdominal Defect: 
In both groups, patients will receive underlay mesh tissue reinforcement followed by standard fascial 
closure with #1 PDS. This technique will require the surgeon to develop a plane between the rectus 
muscle and the posterior rectus sheath or the peritoneum and fascia for mesh placement. The mesh 
product will be placed in the developed space under the defect. As mentioned above, in a rare case 
when larger piece of mesh is required, a second packet of mesh will be opened and the mesh will be 
sutured together as previously mentioned. As described by Dr. Stoppa10-12, the mesh will be secured 
via non-absorbable, full thickness, abdominal wall sutures. Two interrupted sutures will be used to 
anchor the mesh superiorly and two interrupted sutures will be used inferiorly. Additional full 
thickness sutures will be placed every 8 cm circumferentially. After securing the mesh in place, #1 
PDS sutures will be used to close the fascia in a running fashion with 1.5-2 cm “bites” from the fascial 
edge and a 1cm “walk” between stitches.  Skin will be closed with staples or monofilament suture 

 
 
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according to surgeon preference. One or two drains will be placed on the mesh in each case, and one 
or two drains will be placed in the subcutaneous tissues at the discretion of the surgeon depending on 
the amount of subcutaneous tissue dissected. 
 
To qualify for the study, the fascia must be closed completely and without tension. A posterior rectus 
release to relax the fascial closure will be allowed, but a formal components separation, with 
laceration of the external oblique, will disqualify a patient from the study. A mesh bridge is not 
allowed and will result in disqualification from the study. Aside from this restriction, mesh may be 
placed in the preperitoneal or retrorectus position. Careful documentation by the operating surgeon 
of all of the repair components is imperative to avoid introducing bias, as well as precise description 
of the number of transfascial fixation sutures and additional fixation modalities. 
 
 
 
Post-Operative In-Hospital Care: 
All patients will be admitted to the hospital for postoperative monitoring. Depending on the 
preoperative diagnosis and concomitant procedures, patients will typically stay in the hospital for a 
period of 4-7 days. Intravenous antibiotics will be administered to patients with infected wounds and 
at the discretion of the attending surgeon following CDC guidelines. Early clinical outcomes will be 
documented as related to return of GI motility, respiratory status, renal function, pain control, and 
ambulatory status. Criteria for discharge will include absence of fever >100.5oF, adequate oral intake 
to maintain hydration and nutrition, and sufficient pain control with oral analgesics as determined by 
the attending surgeon. 
 
Safety Monitoring: 
Safety  issues  that  may  terminate  the  study  are  significant  differences  in  30  day  mortality  and 
unplanned reoperative interventions, as well as mesh breakdown or wound dehiscence. Given the 
inherently high rates of infection of grade II and III wounds, any observed differences in 
complication rates will be rigorously investigated prior to any sanctions on study continuation. Any 
unexpected mortality will be reported directly to the IRB for their review. Any complications that 
are directly attributed to the implant will also be reported to the IRB. Ronald F. Sing, D.O. will 
perform the role of safety monitor for this study and will be informed of any untoward complication 
including a surgical site infection, seroma formation, wound dehiscence, postoperative evisceration, 
or mortality within 48 hours. Lot numbers for individual mesh products will be recorded in the 
operating room to reference for any complications. In concordance with operating surgeons, any 
untoward events or data as listed above will be reported to the IRB. Current plans are to perform a 
preliminary analysis at N=16 per group patients to evaluate for differences or concerning trends and 
this analysis will be repeated as deemed necessary by the operating surgeons and Dr. Sing. 
Documented meetings will take place every 4 months to discuss any complications and a written 
report will be summarized at the end of each meeting. If statistical significance is reached between 
the groups, or if one group is experiencing clinically worsened outcomes as defined above, we will 
discuss our results with the IRB and terminate the study as deemed necessary. 

 
 
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Outpatient Follow-Up: 
Patients will undergo post-operative follow-up at 1 month, 6 months, and yearly for 3 years. Patients 
will receive reminders of their follow-up visits before each time period.  If the patient is not receiving 
follow-up assessment from Dr. Heniford and his associates, we will also send a provider letter for the 
provider as well as a physician assessment that will be completed by the new provider. At each 
visit, patients will be asked to fill out a short questionnaire (Form A and Form B, attached) that will 
aid in assessing and documenting postoperative symptoms and quality of life. During each follow-up 
visit a board certified or board eligible surgeon, who is blinded with regard to the group assignment, 
will perform a physical examination to assess for the presence of a recurrent hernia, eventration and 
other findings detailed on Form C (attached). Any signs of wound complications will be noted, 
including seroma formation, erythema, drainage, break in the skin, purulence or tenderness to 
palpation. If a recurrent hernia defect is identified on the physical examination, imaging studies will 
be performed as indicated. Once a hernia defect is found, further management options will be 
discussed with the patient. Routine imaging will not be performed as the physical examination has 
been the gold standard for diagnosing abdominal hernias in previous large randomized multicenter 
studies13-14. 
 
 
 
Data Analysis and Statistics 
Demographics, comorbidities, preoperative conditions and the nature of contamination will be 
recorded as well as post-operative hospital course and follow-up findings, including drain outputs, 
the use of antibiotics and drainage procedures, and postoperative quality of life surveys. The latter 
along with hernia recurrences and specific wound complications will be used as primary outcome 
variables. 
 
A power analysis yielded a sample size of 96 patients. With an expected effect size of at least 0.85, it 
was determined that 40 patients in each group will be needed to show significance at the 0.05 level 
with 90% statistical power. In order to accommodate for a 20% attrition rate, 48 patients will be 
recruited into each group. Statistical analysis will be performed using SAS® System version 9.3 (SAS, 
Cary, NC, USA). Both intent-to-treat (ITT) and per protocol analysis will be performed. If the results 
of these two analyses significant differ, efficacy will be determined by the ITT analysis. 
 
Interval outcome variables will be compared using the Wilcoxon-Mann-Whitney test. Serial quality- 
of-life survey results will be compared using repeat-measures ANOVA and non-parametric 
techniques. Frequencies of complications will be analyzed using Chi-square and Fisher's exact test. 
Differences in demographics and preoperative data will be controlled using linear and logistic 
statistical modeling techniques. Once confounders are determined, the effect of mesh type on patient 
outcomes and quality of life will be analyzed using multivariate logistic regression. The significance 
threshold will be set at p<0.05 and will be used for all analyses. 

 
 
 
 
 
 
 
            
 
 
  
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References 
1. Breuing K, Butler CE, Ferzoco S, et al. Incisional ventral hernias: review of the literature and 
recommendations regarding the grading and technique of repair. Surgery. Sep 2010;148(3):544-
558. 
2. Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine 
years' experience with 850 consecutive hernias. Ann Surg. Sep 2003;238(3):391-399; 
discussion 399-400. 
3. Szczerba SR, Dumanian GA. Definitive surgical treatment of infected or exposed ventral 
hernia mesh. Ann Surg. Mar 2003;237(3):437-441. 
4. Cavallaro A, Lo Menzo E, Di Vita M, et al. Use of biological meshes for abdominal wall 
reconstruction in highly contaminated fields. World J Gastroenterol. Apr 21 
2010;16(15):1928-1933. 
5. Harth KC, Broome AM, Jacobs MR, et al. Bacterial clearance of biologic grafts used in hernia 
repair: an experimental study. Surg Endosc. Jul 2011;25(7):2224-2229. 
6. Melman L, Jenkins ED, Hamilton NA, et al. Early biocompatibility of crosslinked and non- 
crosslinked biologic meshes in a porcine model of ventral hernia repair. Hernia. Apr 
2011;15(2):157-164. 
7. Keller JE, Dolce CJ, Walters KC, et al. Effect of bacterial exposure on acellular human dermis 
in a rat ventral hernia model. J Surg Res. Jul 2010;162(1):148-152. 
8. W.L. Gore & Associates, Inc. Gore® Bio-A® Tissue Reinforcement Product 
Brochure.www.goremedical.com/resources/dam/assets/AP3003-EN2.pdf.    Accessed    August 
2012. 
9. Carbonell AM & Matthews BD. Bioabsorbable mesh for complex hernia repair: a technique- 
enhancing surgical tool. General Surgery News Sep 2011:36-37. 
http://www.generalsurgerynews.com/download/BB1158_WM.pdf. Accessed August 2012. 
10. Gaertner WB, Bonsack ME, Delaney JP. Experimental evaluation of four biologic prostheses 
for ventral hernia repair. J Gastrointest Surg. Oct 2007;11(10):1275-1285. 
11. Bauer JJ, Harris MT, Gorfine SR, Kreel I. Rives-Stoppa procedure for repair of large incisional 
hernias: experience with 57 patients. Hernia. Sep 2002;6(3):120-123. 
12. Stoppa RE, Rives JL, Warlaumont CR, Palot JP, Verhaeghe PJ, Delattre JF. The use of Dacron 
in the repair of hernias of the groin. Surg Clin North Am. Apr 1984;64(2):269-285. 
13. Stoppa RE. The treatment of complicated groin and incisional hernias. World J Surg. Sep-Oct 
1989;13(5):545-554. 
14. Itani KM, Hur K, Kim LT, et al. Comparison of laparoscopic and open repair with mesh for 
the treatment of ventral incisional hernia: a randomized trial. Arch Surg. Apr 
2010;145(4):322-328; discussion 328. 
15. Itani KM, Hawn MT. Advances in abdominal wall hernia repair. Preface. Surg Clin North 
Am. Feb 2008;88(1):xvii-xix. 

 
 
 
 
 
 
 
            
 
 
  
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FORM B: 
Patient Questionnaire 
Date of Follow-up:    
 
 
 
Date of Surgery:   
 
Since surgery, have you noticed any of the following at your surgical site: 
 
1. Bulges or protrusions? (No) (Yes)    
 
 
2. Drainage? (None) (Clear) (Bloody) (Yellow) (Other)    
 
 
3. Pain 
(excluding 
expected 
surgical 
pain) 
? 
(None) (As expected) (Dull) (Stabbing) (Burning) (Numbness) Severity (0-10)  
 
Since surgery; (Improving) (Constant) (Worsening)   
 
 
 
 
Since discharge from the hospital, have you had any of the following symptoms: 
 
4. Fever (>100.4)? (No) (Yes) Max Temp:     
 
Bowel problems? (None) (Constipation) (Diarrhea) (Nausea) (Vomiting)   
  
Since surgery, have you had any of the following: 
 
5. Antibiotics 
by 
mouth? 
(No) 
(Yes) 
(Currently 
taking) 
(Completed) 
Why was it prescribed?   
 
 
 
 
 
Name of antibiotic:   
                                              
When and how long did you take it?  
 
 
6. Topical antibiotics for your surgical wound? (No) (Yes) Specify    
 
(Bacitracin) (Neomycin) (Polymyxin) (Bactroban/mupirocin) (Silvadene) 
 
7. An open wound requiring dressing changes? (No) (Yes) 
 
What kind and frequency?    
 
 
8. ER or hospital visits (related to surgery)? (No) (Yes) Specify    
 
 
 
9. Since surgery, have you seen a doctor or surgeon at another institution about your wound, 
abdomen, or other issues related to your surgery? (yes) (no). 
 
If yes, who?    
 

 
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FORM C: 
Abdominal Examination 
 
Examiner:     
 
Circle Appropriate Findings 
Exam: Completely Normal 
 
Incision: 
(clean/dry/intact) 
(necrosis) 
(breakdown) 
Describe  other  than  normal  findings: 
 
 
 
 
If open wound: (since surgery) (reopened) length:   
 width:   
 depth:   
 
Condition: 
(infected) 
(necrosis) 
(improving) 
(exudate) 
(granulation) 
(mesh  exposed) 
Dressing: (plain gauze) (iodoform) (wound vac) Describe:_  
 
 
 
Surrounding skin: (normal) (erythema) (cellulitis) (fluctuance) (induration) 
Deep examination: (normal) (seroma) (granuloma) (abscess) 
Drainage: (none) (serous) (serosang) (purulent) (other)     
 
JP Drains: 
1. (serous) (serosang) (purulent) last 24h output   
 
 
2. (serous) (serosang) (purulent) last 24h output   
 
 
3. (serous) (serosang) (purulent) last 24h output   
 
(removed today) 
(removed today) 
(removed today) 
Presence of Bulge: (none) (laxity) (hernia) size: 
x 
location:   
 
 
Recurrent Hernia: (reducible) (incarcerated) Describe:  
 
 
 
 
 
Assessment 
 
Plan 

 
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FORM D: 
Data Collection 
 
 
Demographics 
Age 
Sex 
Race 
Financial Code 
Case Type 
Admission Date 
Discharge Date 
Length of Stay 
OR Charges 
Total Charges 
Weight 
Height 
Body Mass Index 
Comments 
1° Diagnosis 
2° Diagnoses 
1° Procedure 
2° Procedures 
 
Laboratory / 
Radiology 
CXR 
Blood pressure 
Pulse 
Glascow Coma 
Urea 
Sodium 
Potassium 
Chloride 
Bicarb 
BUN 
Creatinine 
Glucose 
Hemoglobin 
WBC 
Platelet Count 
ECG 
 
Medications 
Steroids 
Coumadin 
Anti-Platelet 
PPI 
Other 
No Medications 
 
Comorbidities 
Alcoholism 
Arrythmia 
Asthma 
CHF 
Cirrhosis 
COPD 
CAD 
CVA 
Diabetes 
ESRD 
HIV 
Hypercholesterol 
Illicit Drugs 
History of Cancer 
Hyperlipidemia 
Hypertension 
Hyperthyroidism 
Hypothyroidism 
Morbid Obesity 
Pulmonary HTN 
PVD 
Sleep Apnea 
Tobacco 
Previous Intra- 
Abdominal 
Surgery 
Abdominal 
Trauma 
Renal 
Insufficiency 
Preop Anemia 
Other 
No 
Commorbidities 
 
Operative Record 
Operation Severity 
Number of 
Operations 
Estimated Blood 
Loss 
Peritoneal 
Malignancy 
Time of Operation 
ASA Score 
Blood Transfusion 
Number of Units 
Estimated Blood 
Loss 
Platelet 
Transfusion 
Morphine 
Equivalents (mg) 
Intra-Operative 
Ultrasound 
Operation Time 
Pathology 
Procedure 
Identification 
Concomitant 
Procedure 
If Yes, type 
Incarceration 
If Yes, Organ 
Enterotomy Made 
Mesh Used 
Current Mesh 
Defect Size 
Mesh Size 
Fibrin Glue 
Postop Persistant 
Pain 
If Yes,Injected 
# times per site 
# sites injected 
Prev Abd Surgery 
Prev Hernia 
Repair 
If Yes, how many 
Previous Wound 
Complications 
Surgical 
Technique 
Previous Mesh 
Ventral Location 
# TA Sutures 
 
PostOperative 
Analgesia 
Hydrocodone 
Dilaudid 
Demerol 
Morphine 
Other 
Analgesia Type 
Mechanism 
PCA/Pump 
Epidural 
IV 
Oral 
Other 
 
Complications 
Air Embolous 
Anast Leak 
Anast Stenosis 
Anesthesia 
Complication 
Atelectasis 
Bladder Injury 
Bleeding 
Bile Duct Injury 
Bowel Injury 
Cardiac 
Arrhythmias 
Cardiac Failure 
Chest Pain 
Colitis 
Constipation 
CVA 
Death 
Deep Infection 
DVT 
Diarrhea 
Enterotomy 
Fever 
Hematoma 
Hernia Recurrence 
Hypercarbia 
Hypertension 
Hypoxia  
Ileus 
Incisional Hernia 
Incision 
Numb/Ting 
Infxn Unknown 
Origin 
Intraabd Abscess 
Kidney Infarction 
Loss Pneumo 
MI 
Nausea 
Pancreatitis 
Enterotomy 
Pneumonia 
Pneumothorax 
Postop 
Hypotension 
Prolong Incision 
Pain 
Mesh Infection 
Pulmonary 
Embolism 
Readmission 30 
Days 
Renal Failure 
Reoperation 
Resp Failure 
Septicemia 
Seroma 
SBO 
Splenic Injury 
Subcutaneous 
Emphysema 

 
 
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Ureteral Injury 
Urinary Retention 
Urine Leak 
UTI 
Vomiting 
Other 
 
Follow-up Data 
Drains 
Wound Comp 
Non-related Comp 
Visual Analog 
Scale 
Date Return to 
Work 
Date Return 
Driving 
Date Return 
Exercise 
Preop Sym 
Returned 
Oral Pain Med 
Amt 
Patient Feels Mesh 
Patient has Pain 
Pain Location 
Pain Exercise Only 
Date No Postop 
Pain 
Hernia Sites 
Injected 
# Sites Injected 
Total Times 
Injected 
Hernia Recurrence 
Recurrence Date 
 
Wound 
Complications 
Antibiotics IV 
Antibiotics PO 
Cellulitis 
Open wound 
Wound Disruption 
 
Wound 
Dehiscence 
Wound Necrosis 
Drain Placement 
Drainage Clear 
Drainage (nos) 
Drainage Purulent 
EC Fistula 
Erythema 
Inflammation 
Fistula 
Hematoma 
Wound Infection 
Local skin 
infection 
Wound Abscess 
Deep Infection 
Mesh Infection 
Infected Seroma 
Intraabd Infection 
Intraabd Abscess 
Ischemia 
Seroma 
Seroma 
Intervention 
Wound 
Intervention 
Wound Vac 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 15 of 28 
 
 
 
Carolinas Medical Center 
Carolinas HealthCare System 
 
 
Dear Patient: 
 
You are receiving this letter because you have agreed to be in our study involving your 
recent hernia repair.  We are contacting you in respect to 1 month follow up after your 
surgery. 
 
The enclosed form is a questionnaire to be completed by a medical provider.  We would 
prefer you come to Carolinas Medical Center to be seen by our surgical team, however 
due to time and distance we understand if this is not possible.    We have outlined on the 
form enclosed specific questions about the healing of your surgical site.  This form can be 
completed at the time of your next medical appointment you have scheduled and should 
take approximately 3 minutes of the appointment. 
 
We have also included a letter to give to the provider who will be seeing you for this 
appointment to explain the need for this assessment from your involvement in the study.  
We hope you are doing well and please contact us at (704)-355-1813 for any questions or 
concerns you may want to discuss. 
 
Thank you very much for your time. We hope to hear from you soon. 
 
Sincerely, 
 
 
 
B. Todd Heniford, MD 
 
 
 
Principal Investigator 
 
 
 
 
 
 
 
 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 16 of 28 
 
 
 
Carolinas Medical Center 
Carolinas HealthCare System 
 
 
Dear Patient: 
 
You are receiving this letter because you have agreed to be in our study involving your 
recent hernia repair.  We are contacting you in respect to 6 month follow up after your 
surgery. 
 
The enclosed form is a questionnaire to be completed by a medical provider.  We would 
prefer you come to Carolinas Medical Center to be seen by our surgical team, however 
due to time and distance we understand if this is not possible.    We have outlined on the 
form enclosed specific questions about the healing of your surgical site.  This form can be 
completed at the time of your next medical appointment you have scheduled and should 
take approximately 3 minutes of the appointment. 
 
We have also included a letter to give to the provider who will be seeing you for this 
appointment to explain the need for this assessment from your involvement in the study.  
We hope you are doing well and please contact us at (704)-355-1813 for any questions or 
concerns you may want to discuss. 
 
Thank you very much for your time. We hope to hear from you soon. 
 
Sincerely, 
 
 
 
B. Todd Heniford, MD 
 
 
 
Principal Investigator 
 
 
 
 
 
 
 
 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 17 of 28 
 
 
 
Carolinas Medical Center 
Carolinas HealthCare System 
 
 
Dear Patient: 
 
You are receiving this letter because you have agreed to be in our study involving your 
recent hernia repair.  We are contacting you in respect to 12 month follow up after your 
surgery. 
 
The enclosed form is a questionnaire to be completed by a medical provider.  We would 
prefer you come to Carolinas Medical Center to be seen by our surgical team, however 
due to time and distance we understand if this is not possible.    We have outlined on the 
form enclosed specific questions about the healing of your surgical site.  This form can be 
completed at the time of your next medical appointment you have scheduled and should 
take approximately 3 minutes of the appointment. 
 
We have also included a letter to give to the provider who will be seeing you for this 
appointment to explain the need for this assessment from your involvement in the study.  
We hope you are doing well and please contact us at (704)-355-1813 for any questions or 
concerns you may want to discuss. 
 
Thank you very much for your time. We hope to hear from you soon. 
 
Sincerely, 
 
 
 
 
B. Todd Heniford, MD 
 
 
 
Principal Investigator 
 
 
 
 
 
 
 
 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 18 of 28 
 
 
 
Carolinas Medical Center 
Carolinas HealthCare System 
 
 
Dear Patient: 
 
You are receiving this letter because you have agreed to be in our study involving your 
recent hernia repair.  We are contacting you in respect to 24 month follow up after your 
surgery. 
 
The enclosed form is a questionnaire to be completed by a medical provider.  We would 
prefer you come to Carolinas Medical Center to be seen by our surgical team, however 
due to time and distance we understand if this is not possible.    We have outlined on the 
form enclosed specific questions about the healing of your surgical site.  This form can be 
completed at the time of your next medical appointment you have scheduled and should 
take approximately 3 minutes of the appointment. 
 
We have also included a letter to give to the provider who will be seeing you for this 
appointment to explain the need for this assessment from your involvement in the study.  
We hope you are doing well and please contact us at (704)-355-1813 for any questions or 
concerns you may want to discuss. 
 
Thank you very much for your time. We hope to hear from you soon. 
 
Sincerely, 
 
 
 
 
B. Todd Heniford, MD 
 
 
 
Principal Investigator 
 
 
 
 
 
 
 
 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 19 of 28 
 
 
 
Carolinas Medical Center 
Carolinas HealthCare System 
 
 
Dear Patient: 
 
You are receiving this letter because you have agreed to be in our study involving your 
recent hernia repair.  We are contacting you in respect to 36 month follow up after your 
surgery. 
 
The enclosed form is a questionnaire to be completed by a medical provider.  We would 
prefer you come to Carolinas Medical Center to be seen by our surgical team, however 
due to time and distance we understand if this is not possible.    We have outlined on the 
form enclosed specific questions about the healing of your surgical site.  This form can be 
completed at the time of your next medical appointment you have scheduled and should 
take approximately 3 minutes of the appointment. 
 
We have also included a letter to give to the provider who will be seeing you for this 
appointment to explain the need for this assessment from your involvement in the study.  
We hope you are doing well and please contact us at (704)-355-1813 for any questions or 
concerns you may want to discuss. 
 
Thank you very much for your time. We hope to hear from you soon. 
 
Sincerely, 
 
 
 
 
B. Todd Heniford, MD 
 
 
 
Principal Investigator 
 
 
 
 
 
 
 
 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 20 of 28 
 
 
Carolinas Medical Center 
Carolinas HealthCare System 
Physician Assessment: 
Patient Name: ___________________________________   Date of Operation: 
_____________________ 
Abdominal Exam: (check ALL that apply) 
Incision? 
 Clean/dry/intact 
 
 necrosis 
 
 breakdown 
 
 other       
specify:______________________________________________ 
 
Open Wound? 
If yes:  
 yes 
 since surgery 
 no 
 reopened 
 
Length ___________ 
width_____________ depth______________ 
 
If yes to Open Wound, Condition of Wound: 
 infected 
 does not apply 
 necrosis 
 
 improving 
 
 fibrinous exudate 
 
 granulation 
 
 mesh exposed 
 
 other    specify: 
_______________________________________________ 
 
If yes to Open Wound, Dressing applied: 
 plain gauze (wet to dry) 
 does not apply 
 iodoform 
 
 wound vacuum 
 
 other  specify: 
_______________________________________________ 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 21 of 28 
 
 
Surrouding Skin: 
 normal 
 
 erythema 
 
 cellulitis 
 
 fluctuance 
 
 induration 
 
Deep Examination: 
 normal 
 
 seroma 
 
 granuloma 
 
 abscess 
 
Drainage? 
 none 
 
 serous 
 
 serosanguinous 
 
 purulent 
 
 other
 
specify:____________________________________________
___ 
 
Presence of 
Bulge? 
 none 
 
 laxity, does not feel like hernia but slight bulging 
 
 yes, feels like hernia 
 
 uncertain 
 
If yes to bulge: 
Location: 
________________________________ 
 does not apply 
Length: 
__________________________________ 
 
Width: 
__________________________________ 
 
If yes to bulge:  
 reducible 
 does not apply 
 incarcerated (non reducible) 
 
 associated with pain 
 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 22 of 28 
 
Please provide any additional comments/concerns about your examination today: 
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
______________________________________________________________________________
___________________________________ 
 
May we contact you for additional information on your assessment today?  
 Yes (provide contact # 
below) 
 No 
Would you like to be contacted in regards to your assessment today? 
 Yes (provide contact # 
below) 
 No 
Provider 
Name:________________________________________________________________________ 
Provider Signature:_________________________________________ Date 
Examined:_______________ 
Contact 
Number:_______________________________________________________________________ 
Thank you for your time and completion of the assessment. 
 
 
 
 
 
 
 
 
 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 23 of 28 
 
 
Carolinas Medical Center 
Carolinas HealthCare System 
 
 
Dear Provider: 
 
You are receiving this letter because your patient has agreed to be in our study involving 
their recent hernia repair.  We are contacting the patient at this point in time for 1 month 
follow up after their surgery. 
 
The enclosed form is a questionnaire to be completed by you as the medical provider.  
We would be glad to see the patient at Carolinas Medical Center by our surgical team, 
however due to time and distance we understand if this is not possible.  We have outlined 
on the form enclosed specific questions about the healing of the patient’s surgical site.  
This form can be completed at a convenient time and should take approximately 3 
minutes of the appointment. 
 
Please contact us at (704)-355-1813 for any questions or concerns you may want to 
discuss. 
 
Thank you very much for your time. 
 
Sincerely, 
 
 
 
 
B. Todd Heniford, MD 
 
 
 
Principal Investigator 
 
 
 
 
 
 
 
 
 
 
 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 24 of 28 
 
 
 
Carolinas Medical Center 
Carolinas HealthCare System 
 
 
Dear Provider: 
 
You are receiving this letter because your patient has agreed to be in our study involving 
their recent hernia repair.  We are contacting the patient at this point in time for 6 month 
follow up after their surgery. 
 
The enclosed form is a questionnaire to be completed by you as the medical provider.  
We would be glad to see the patient at Carolinas Medical Center by our surgical team, 
however due to time and distance we understand if this is not possible.    We have 
outlined on the form enclosed specific questions about the healing of the patient’s 
surgical site.  This form can be completed at a convenient time and should take 
approximately 3 minutes of the appointment. 
 
Please contact us at (704)-355-1813 for any questions or concerns you may want to 
discuss. 
 
Thank you very much for your time. 
 
Sincerely, 
 
 
 
 
B. Todd Heniford, MD 
 
 
 
Principal Investigator 
 
 
 
 
 
 
 
 
 
 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 25 of 28 
 
 
Carolinas Medical Center 
Carolinas HealthCare System 
 
 
Dear Provider: 
 
You are receiving this letter because your patient has agreed to be in our study involving 
their recent hernia repair.  We are contacting the patient at this point in time for 12 month 
follow up after their surgery. 
 
The enclosed form is a questionnaire to be completed by you as the medical provider.  
We would be glad to see the patient at Carolinas Medical Center by our surgical team, 
however due to time and distance we understand if this is not possible.    We have 
outlined on the form enclosed specific questions about the healing of the patient’s 
surgical site.  This form can be completed at a convenient time and should take 
approximately 3 minutes of the appointment. 
 
Please contact us at (704)-355-1813 for any questions or concerns you may want to 
discuss. 
 
Thank you very much for your time. 
 
Sincerely, 
 
 
 
 
B. Todd Heniford, MD 
 
 
 
Principal Investigator 
 
 
 
 
 
 
 
 
 
 
 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 26 of 28 
 
 
Carolinas Medical Center 
Carolinas HealthCare System 
 
 
Dear Provider: 
 
You are receiving this letter because your patient has agreed to be in our study involving 
their recent hernia repair.  We are contacting the patient at this point in time for 24 month 
follow up after their surgery. 
 
The enclosed form is a questionnaire to be completed by you as the medical provider.  
We would be glad to see the patient at Carolinas Medical Center by our surgical team, 
however due to time and distance we understand if this is not possible.    We have 
outlined on the form enclosed specific questions about the healing of the patient’s 
surgical site.  This form can be completed at a convenient time and should take 
approximately 3 minutes of the appointment. 
 
Please contact us at (704)-355-1813 for any questions or concerns you may want to 
discuss. 
 
Thank you very much for your time. 
 
Sincerely, 
 
 
 
 
B. Todd Heniford, MD 
 
 
 
Principal Investigator 
 
 
 
 
 
 
 
 
 
 
 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 27 of 28 
 
 
Carolinas Medical Center 
Carolinas HealthCare System 
 
 
Dear Provider: 
 
You are receiving this letter because your patient has agreed to be in our study involving 
their recent hernia repair.  We are contacting the patient at this point in time for 36 month 
follow up after their surgery. 
 
The enclosed form is a questionnaire to be completed by you as the medical provider.  
We would be glad to see the patient at Carolinas Medical Center by our surgical team, 
however due to time and distance we understand if this is not possible.    We have 
outlined on the form enclosed specific questions about the healing of the patient’s 
surgical site.  This form can be completed at a convenient time and should take 
approximately 3 minutes of the appointment. 
 
Please contact us at (704)-355-1813 for any questions or concerns you may want to 
discuss. 
 
Thank you very much for your time. 
 
Sincerely, 
 
 
 
 
B. Todd Heniford, MD 
 
 
 
Principal Investigator 
 
 
 
 
 
 
 
 
 
 
 

 
Bio-A vs Strattice 
Version: 2nd 
Date: 7/29/2014 
Page 28 of 28 
 
 
Carolinas Medical Center 
Carolinas HealthCare System 
 
 Reminder for Follow Up 
Patient Name:_________________________      Date of Surgery:__________________________ 
Please contact us approximately 2-3 weeks prior to the following follow up interval times to 
coordinate a clinic appointment with your surgeon. 
1 month:____________  
 
Appointment Time:________________________ 
6 month:____________  
 
Appointment Time:________________________ 
12 month:___________  
 
Appointment Time:________________________ 
24 month:___________  
 
Appointment Time:________________________ 
36 month: __________  
 
Appointment Time:________________________ 
If you would prefer us to call you for the appointments, please check below and provide us a 
contact number. 
 Please contact me for follow up reminders    Contact 
#:__________________________________ 
 
 Please contact me via email for follow up reminders   E-
mail:_____________________________ 
 
 Please do not contact me, I will call 704-355-1813 for follow-up reminders.