Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment

Study Overview
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Brief Summary
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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 and dermatologic surgeons will then complete surveys 7 days, 30 days, and 90 days after surgery to evaluate the cosmetic appearance of these scars.

Official Title
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Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment: A Randomized Controlled Trial

Conditions
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Skin Scarring, Skin Cancer, Wound Heal, Wound of Skin, Surgical Wound, Patient Satisfaction, Patient Preference, Surgical Incision, Scar

Intervention / Treatment
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* Device: Hydrocolloid dressing
* Other: Petrolatum jelly dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult > 18 years of age Linear scars Patients underwent conventional excision or Mohs micrographic surgery for primary cutaneous cancer or other cutaneous condition that required surgical intervention Exclusion Criteria: Scar localization on acral or hair bearing sites Patients unable to converse in English Patients requiring flap or graft for closure of wound History of allergy to adhesives Patient using topical chemotherapy agents on the surgical site or planning to start it within 3 months after surgery Use of hydrocolloid dressings for post-operative wound care in the past

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each patient will have the surgical scar treated with either type of intervention
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydrocolloid dressing arm<br>After informed consent and 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) | Device: Hydrocolloid dressing<br>* A single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery<br>|
| Active Comparator: Petrolatum jelly dressing arm<br>and the other group of patients (control), after closing the wound with the sutures, the scar will be covered with petrolatum jelly during this time period, which has to be re-applied daily. | Other: Petrolatum jelly dressing<br>* The patient with the control wound will be covered with petrolatum jelly during this time period, which has to be re-applied daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic outcome | Patient and surgeon assessment of cosmetic outcome using modified visual analogue scar scale. The minimum value is 1 and the maximum value is 10. 1 is the worst possible scar appearance and 10, is the best possible scar appearance. | 7 days | 
| Cosmetic outcome | Patient and surgeon assessment of cosmetic outcome using modified visual analogue scar scale. The minimum value is 1 and the maximum value is 10. 1 is the worst possible scar appearance and 10, is the best possible scar appearance. | 30 days | 
| Cosmetic outcome | Patient and surgeon assessment of cosmetic outcome using modified visual analogue scar scale. The minimum value is 1 and the maximum value is 10. 1 is the worst possible scar appearance and 10, is the best possible scar appearance. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | 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 | 7 days, 30 days, 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scar, surgical incision, patient satisfaction, patient preference, cosmetic outcome, scar appearance, dermatologic surgery, wound healing, wound of skin, skin cancer