Effect of Replacing Buried Sutures With Tissue Adhesive on Aesthetic Outcome of Surgical Wounds.
Phase: NA
Conditions: Surgical Wound
Sponsor: West Virginia University

Clinical Protocol 
Principal Investigator 
 
Michael Kolodney, MD, PhD, BS 
Department 
 
 
Dermatology 
Protocol Number 
 
1710792979 
Study Title 
 
:  
Effect of replacing buried sutures with tissue adhesive on aesthetic 
outcome of surgical wounds.  
1. Subjects will be recruited from patients scheduled for surgery at the WVU University Town 
Centre (UTC) dermatology clinic.  
2. Criteria for enrolment consists of the following: age 18 years or older with postoperative defects 
of at least 3 cm, resulting from either Mohs micrographic surgery or surgical excision at the 
West Virginia University dermatology clinic. Those eligible will be willing to give informed 
consent and return for follow-up visits 3 months and 6 months following surgery. Patients will 
be excluded if they are pregnant, unable to understand English, mentally impaired, incarcerated, 
or have nonlinear closures.  
3. Potential subjects who meet criteria and express interest will be given a written consent form at 
the WVU UTC dermatology clinic by study personnel prior to enrolling in the study.  
4. Potential subjects will be verbally informed of all pertinent information regarding the study. 
They will be given ample time to ask questions and make an informed decision as to whether or 
not they wish to enroll in the study.  
5. Patients undergoing multiple surgical repairs on the same visit can include up to three closures 
in the study.  
6. Each closure will be assigned a study number.   
7. Surgeons of varying experience levels (i.e. attending, fellows, and residents) will be included in 
the study in order to increase external validity.  
8. Wounds halves will be labeled as A (left/superior) or B (right/inferior), the halves will be 
randomized to receive either tissue glue or deep sutures. The nurse will refer to the 
randomization list and inform the surgeon which side of the wound will receive tissue glue and 
which side will receive deep sutures.  Following common practice of wound labeling, side A will 
always be left or superior from the surgeon’s perspective, whereas side B will always be right or 
inferior from the surgeon’s perspective. 
9. Per randomization, half of the wound will be closed with deep absorbable sutures followed by 
superficial non-absorbable sutures. The other half of the wound will be closed with superficial 
non-absorbable sutures followed by tissue glue (Dermabond).  Tissue glue will be spread to 
cover an area extending one cm from the wound margin on both sides.  
10. Patients will be instructed to use a cotton-tipped applicator to apply petroleum jelly only to the 
side of their wound without tissue glue two times a day for one week following surgery.   
11. After suture removal, tissue glue will be re-applied to both halves of the wound.  
12. We plan to enroll 70 wounds in the study in order to detect a difference of 4 on the Patient 
Observer Scar-Assessment Scale, since the scale is based on a 60-point system. We calculated 
that we would need to enroll at least 40 subjects using an assumed standard deviation of 7.6, 
Approved:22-Jan-2018Expires:9-Jan-2019Number:1710792979

alpha of 0.05, and a power of 90. However, due to the length of the study we expect a dropout 
rate of approximately 40%. 
13. Wounds will be evaluated at 3 month and 6 month follow-ups. These time points were chosen 
due to the ability to see differences in surgical interventions at these time points, while 
differences in surgical interventions are more difficult to distinguish over time. In addition, study 
quality will decrease over time since patients will be more likely to drop out of the study.  
14. The efficacy of intervention methods will be assessed at the 3 month and 6 month follow-ups by 
having the patient and two blinded observers rate the healing progression of the wound using 
the POSAS. The observers will be either dermatology faculty or dermatology. The POSAS is a 
standard metric in measuring wound healing in cutaneous surgery studies since it does not 
require training but takes into account the scar assessment of the patient and observers. 
Subsequently, the height and width of the scar will be measured and compared to the 
surrounding unaffected skin. The assessments of the two blind observers will be averaged. Data 
will be managed using REDCap, a World Wide Web-based data collection page. All adverse 
events and any complications will be consistently monitored and recorded for each side of the 
scar.  
15. After the patients have their scar observed at the 3 month and 6 month follow-ups, they will be 
financially compensated for their travel and participation in the study. Patients will be paid $50 
for each visit, potentially earning a total of $100 for their participation in the study. This money 
will be provided by funds from the WVU Department of Dermatology. Patients will be asked to 
provide their Social Security Number and verification of U.S Citizenship or Permanent Resident 
Status to receive payment. 
16. We will use a paired Wilcoxon test to compare the mean POSAS scores for the two wound 
closure techniques at 3 and 6 months after surgery. To compare differences in scar height, 
width, and depth between the two closure techniques at the 3 and 6 month follow-ups paired 
Wilcoxon tests will be used. McNemar tests will be used to calculate differences in the 
proportion of scars with measurable heights and depths between the two wound closure 
techniques. This will help account for instances where patients have a scar height and depth of 
zero. R statistical computing software will be used to run statistical analyses (R Foundation for 
Statistical Computing, Vienna, Austria). The intent-to-treat principle will be used to compute the 
study outcomes.  
Approved:22-Jan-2018Expires:9-Jan-2019Number:1710792979