Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment

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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgical Wound; Skin Cancer; Scar; Wound Heal; Patient Satisfaction; Surgical Incision; Patient Preference; Skin Scarring; Wound of Skin
• Intervention / Treatment: Device: Hydrocolloid dressing; Other: Petrolatum jelly dressing

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Recruiting
      • IU Health Physicians Dermatology Meridian Crossing
      • Contact: Syril Keena T Que, MD, MPH; Phone Number: 317-944-4000; Email: sque@iuhealth.org
      • Principal Investigator: Syril Keena T Que, MD, MPH
      • Sub-Investigator: Maria C Bell, MD
      • Sub-Investigator: Claudia Morr
      • Sub-Investigator: Arslan Iqbal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria:

1. Scar localization on acral or hair bearing sites
2. Patients unable to converse in English
3. Patients requiring flap or graft for closure of wound
4. History of allergy to adhesives
5. Patient using topical chemotherapy agents on the surgical site or planning to start it within 3 months after surgery
6. Use of hydrocolloid dressings for post-operative wound care in the past

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hydrocolloid dressing arm; 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; A single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery
Active Comparator: Petrolatum jelly dressing arm; 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; The patient with the control wound will be covered with petrolatum jelly during this time period, which has to be re-applied daily.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indiana University

Publications and helpful links

General Publications

• Holmes SP, Rivera S, Hooper PB, Slaven JE, Que SKT. Hydrocolloid dressing versus conventional wound care after dermatologic surgery. JAAD Int. 2021 Dec 21;6:37-42. doi: 10.1016/j.jdin.2021.11.002. eCollection 2022 Mar.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Estimated): August 17, 2024
• Study Completion (Estimated): August 17, 2024

Study Registration Dates

• First Submitted: October 23, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: scar; patient preference; wound healing; patient satisfaction; skin cancer; scar appearance; surgical incision; dermatologic surgery; wound of skin; cosmetic outcome
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Fibrosis; Wounds and Injuries; Surgical Wound; Skin Neoplasms; Cicatrix; Dermatologic Agents; Emollients; Petrolatum
• Other Study ID Numbers: 15768

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes