Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment: A Randomized Controlled Trial
Phase: NA
Conditions: Scar, Skin Scarring, Skin Cancer, Wound Heal, Wound of Skin, Surgical Wound, Patient Satisfaction, Patient Preference, Surgical Incision
Sponsor: Indiana University

V 10.6.2022 
 
Scar appearance after hydrocolloid dressing versus petrolatum 
ointment: a randomized control trial 
 
 
                                     Principal Investigator 
                                                
                                                  Syril Keena Que, MD, MPH 
 
 
 
Director of Dermatologic Surgery and Cutaneous Oncology 
       Associate Program Director, Micrographic Surgery and Dermatologic Oncology Fellowship  
11590 N. Meridian St., Suite 450 
Carmel, IN 46032 
 
 
 
 
 
 
 
 
 
                                                   Sub-Investigator  
                                     
                                    Maria C. Bell, MD, Department of Dermatology 
Arslan Iqbal MD, Department of Dermatology 
Claudia Morr, MD, Department of Dermatology 
                                                         
                                                         
                                       
                                       
 
 
Support Provided by: 
N/A 
 
 
 
 
 
 
 
 
 
 
 

V 10.6.2022 
 
 
Table of Contents: 
 
 
 
Study Schema 
1.0 
Background & Rationale 
2.0 
Objective(s) 
2.1 
Primary Objective 
2.2 
Secondary Objective 
2.3 
Tertiary/Exploratory/Correlative Objectives 
3.0 
Outcome Measures 
3.1 
Primary Outcome Measures 
3.2 
Secondary Outcome Measures 
3.3 
Tertiary/ Exploratory/ Correlative Outcome Measures 
4.0 
Eligibility Criteria 
4.1 
Inclusion Criteria 
4.2 
Exclusion Criteria 
5.0 
Study Design 
6.0 
Enrollment/Randomization 
7.0 
Reportable Events 
8.0 
Data Safety Monitoring 
9.0 
Study Withdrawal/Discontinuation 
10.0 Statistical Considerations 
11.0 Data Management 
12.0 Privacy/Confidentiality Issues 
13.0 Follow-up and Record Retention 
14.0 References 
15.0 Appendix 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

V 10.6.2022 
 
1.0 Background and Introduction: 
 
Cosmetic satisfaction has become increasingly important in modern era especially for elective surgical 
procedures(1). While postoperative scarring is inevitable, improved scar treatment and prevention has the 
potential to improve a patient’s health-related quality of life (2). Although there are multiple scar 
assessment scales, but five most frequently used scales are: Vancouver Scar Scale (VSS), Visual 
Analogue Scale (VAS) and Patient and Observer Scar Assessment Scale (POSAS), Manchester Scar 
Scale (MSS) and Stony Brook Scar Evaluation Scale (SBSES)(3). 
 
We will be using a Visual Analog Scale (VAS) for our study. For this study scar assessment will be 
performed by review of photographs to allow for inclusion of a larger group of assessors and eligible 
patients than would be possible with in-person assessment. The patient will also be asked to provide 
assessment based on these parameters. Evaluators will be physicians including medical students, 
residents, fellows, and attending surgeons.  
   
Our main aim of this study is to evaluate the difference in cosmetic outcomes for patients whose post-
operative wound was treated with hydrocolloid dressing vs petrolatum ointment (Vaseline) after excision 
or Mohs surgery for cutaneous malignancy or other cutaneous conditions that require surgical 
intervention. Scar cosmesis will be assessed using the VAS.  
 
 
2.0 Objective: 
 
2.1 Primary Objective 
 
1) To determine the difference in scar cosmesis using a hydrocolloid dressing vs petrolatum jelly 
after Mohs surgery or conventional excision.  
 
2.2 Secondary Objective: 
 
2) To compare the complication rate in patients using a hydrocolloid dressing vs petrolatum jelly 
after Mohs surgery or conventional excision. 
 
 
3.0 Outcome measures: 
 
 3.1 Primary outcome measure: 
         
• 
Both the patient and external evaluators (residents, Mohs fellow, other surgeons) will score the 
outcome of the scar based on the VAS. External evaluators will assess and score the scar by 
reviewing a high-quality photograph taken 7 days, 30 days and 90 days after surgery.  
 
 
3.2 Secondary outcome measure: 
 
• 
Complication rate including hematoma, seroma, wound infection requiring antibiotics, opening 
and drainage of wound, dehiscence. Complications will be assessed by physicians other than 
operating surgeon.  
 

V 10.6.2022 
 
 
4.0 Eligibility Criteria: 
 
4.1   Inclusion Criteria:  
  
1) Adult > 18 years of age 
2) Linear scars 
3) Patients underwent conventional excision or Mohs micrographic surgery for primary cutaneous 
cancer or other cutaneous condition that required surgical intervention 
      
4.2 Exclusion Criteria:  
   
1) Age < 18 years of age  
2) Scar localization on acral or hair bearing sites 
3) Patients unable to converse in English 
4) Patients requiring flap or graft for closure of wound 
5) History of allergy to adhesives 
6) Patient using topical chemotherapy agents on the surgical site or planning to start it within 3 
months after surgery 
7) Use of hydrocolloid dressings for post-operative wound care in the past 
 
 
5.0 
Study Design: 
 
• Subjects >18 years of age admitted to the Indiana University Department of Dermatology for an 
excisional surgery by Dr. Syril Keena Que 
 
• 
After informed consent is signed, patients will be randomized either to receive standard daily 
dressing or hydrocolloid dressing using a randomization generator. After closing the wound with 
the sutures, the scar will be covered by a hydrocolloid dressing, which will be left in place for 7 
days (Experimental) or the standard dressing (Control) that will be covered with petrolatum jelly 
and bandaging during this time period, which has to be re-applied daily.  
 
• 
Patients will be followed up at 7, 30 and 90 days after surgery for photographic scar evaluation 
by multiple physicians. 
 
• 
Variables recorded: name, DOB, sex, contact information, primary cutaneous condition 
diagnoses, anatomic site, pathologic report, postoperative scar length, postoperative 
complications, patient VAS scores, and external evaluator (physician or medical student) VAS 
scores. External evaluators will be blinded as to the side treated with hydrocolloid dressings. 
One week after undergoing the procedure, patients will be contacted over the phone by study 
staff (other than the primary surgeon) and will be asked for their responses to the Modified 
Bluebelle Questionnaire. Version 1 of this questionnaire is for patients who received 
conventional dressing and version 2 for patients who received hydrocolloid dressing. Patients 
will be given the option to mail back a paper version of the completed survey, if they prefer. 
 
• 
Data will be captured in Redcap and exported in excel file for statistical analysis.  

V 10.6.2022 
 
• 
Statistical tests: Will be performed with the assistance of an experienced biostatistician. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment of initial subject pool 
Inclusion of consecutive patients that present to IU 
Meridian Crossing clinic with primary cutaneous 
cancer.  
Initial screening and consent 
Conduct baseline assessment, provide study materials, etc.  
• 
Subjects who will qualify for inclusion receive a copy of their signed authorization 
for release of health information form and a copy of the signed informed consent 
form 
• 
Any questions from the subject will be answered by Pi or co-investigator.  
 
Scar Covering 
• 
After the placement of sutures, the scar will be covered by hydrocolloid dressing, 
which will be left in place for 1 week (Experimental) or with petrolatum jelly, which 
will be re-applied by the patient daily for 1 week.  
• 
A randomization generator will be used to determine which wound is treated with 
hydrocolloid dressing. The study will be conducted until there is an equal number in 
each arm. 

V 10.6.2022 
 
 
 
 
 
 
 
6.0 
Enrollment/Randomization 
 
Participants will be identified by their general dermatologists as candidates for excision or Mohs surgery. 
After a discussion of risks, benefits, and alternatives, if the patients choose to undergo surgical excision 
via conventional excision or Mohs, they will be given the option to participate in this study. After 
explaining the study, patient consent will be taken on the day of surgery.  
One week after surgery, patients will be followed up either in clinic or contacted over the phone to fill the 
VAS questionnaire. Patients will also be given an option to complete the questionnaire via email, if they 
prefer.  
 
All surgical procedures and physical interventions will be conducted as part of standard clinical care. The 
only element performed as part of research is collection of survey data relating to scar assessment and 
satisfaction.  
 
7.0 
Reportable Events 
 
All adverse events or deviations of the protocol will be documented as per date, reason and all deviation 
will be presented to the clinical trials team and communicated to the IRB committee as required per 
institutional policies and federal regulations.  
 
8.0 
Data Safety Monitoring 
 
This is a minimal risk study and data will be stored in a secure database to ensure patient privacy and 
confidentiality. 
 
9.0 
Study Withdrawal/Discontinuation 
 
Patients may withdraw from the study at any time on the day of their procedure by letting their nurse or 
surgeon know they no longer wish to participate. Incomplete surveys will be collected and destroyed. 
Patients may be withdrawn from the study if they meet any exclusion criteria that were not immediately 
apparent at time of enrollment. 
 
 
10.0 
Statistical Considerations 
 
Statistical power will be set at 0.80 with an assumed effect size of 0.2. With an alpha value of 0.05, the 
study will require 100 patients to achieve this statistical power. A 95% confidence interval will be used to 
determine significance.  
 
Any feasible potential outliers have been identified and will be included in the survey and statistical 
analysis. Statisticians will provide ongoing assistance with data analysis throughout the study. 
 
 
11.0 
Statistical Data Management 
Scar Assessment  
A follow-up assessment will be conducted 7 days, 30 days AND 90 
days after the surgery. Patients will be given VAS assessment 
questionnaire and the modified bluebelle questionnaire on the day of 
surgery, will be contacted via phone at specific time periods. 
Clinicians will evaluate the scar outcome through the use of high-
quality photographic images.

V 10.6.2022 
Primary data will be collected on REDCap and Excel with the survey administered in office via tablet or a 
paper version. Phone interviews will be conducted as mentioned timelines after the surgery, with patients 
given the option to complete the survey via email if they prefer. Medical records will be assessed, and 
data will be stored electronically in REDCap and Excel on the Dermatology Department Server.  The 
storage location will be backed up manually every week.  Other data sources include data from the Cerner 
medical record system, which will be incorporated into the Excel sheet or REDCap workbook, as needed.  
Quality assurance steps will include: testing of database by study team prior to moving to production 
mode.  The following quality control methods will be used: extraction and cleaning of data that will be 
used for analysis every 3 months. 
 
12.0 
Privacy/Confidentiality Issues 
 
All patient identifying information (name, MRN, phone number, skin cancer type, date of surgery, etc.) 
collected in this study will be deidentified prior to data analysis. All written records will be converted to a 
computerized database and subsequently destroyed.  
 
 
13.0 
Follow-up and Record Retention 
 
Data will be collected for 5 years after patient enrollment, beginning on or after July up until 1 years after 
the last patient is enrolled or until study termination. Data will be entered into a computerized database on 
a rolling basis as it is collected. Written records will be destroyed. 
 
 
14.0 References 
 
1. 
Corrado G, Calagna G, Cutillo G, Insinga S, Mancini E, Baiocco E, et al. The Patient and 
Observer Scar Assessment Scale to Evaluate the Cosmetic Outcomes of the Robotic Single-Site 
Hysterectomy in Endometrial Cancer. Int J Gynecol Cancer. 2018;28(1):194-9. 
2. 
Huang LC, Chen DZ, Chen LW, Xu QC, Zheng ZH, Dai XF. The use of the Scar Cosmesis 
Assessment and rating scale to evaluate the cosmetic outcomes of totally thoracoscopic cardiac surgery. J 
Cardiothorac Surg. 2020;15(1):250. 
3. 
Fearmonti R, Bond J, Erdmann D, Levinson H. A review of scar scales and scar measuring 
devices. Eplasty. 2010;10:e43.