Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment

NCT05618912 | Completed Results DMC FDA Device

• 1 other identifier: 15768
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

scar; dermatologic surgery; wound healing; wound of skin; skin cancer; surgical incision; patient satisfaction; patient preference; cosmetic outcome; scar appearance

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Participants With Complications

  7 days, 30 days, 90 days

Study Arms (2)

hydrocolloid dressing arm

EXPERIMENTAL

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

Petrolatum jelly dressing arm

ACTIVE COMPARATOR

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

Interventions

Hydrocolloid dressing DEVICE

A single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery

hydrocolloid dressing arm

Petrolatum jelly dressing OTHER

The patient with the control wound will be covered with petrolatum jelly during this time period, which has to be re-applied daily.

Petrolatum jelly dressing arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

IU Health Physicians Dermatology Meridian Crossing

Carmel, Indiana, 46032, United States

Location

Related Publications (2)

• 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.

  PMID: 34993497 BACKGROUND

• Bell MC, Gangodawila TW, Morr CS, Xue GR, Iqbal A, Merkel EA, Abdulhak AH, Slaven JE, Que SKT. Hydrocolloid Dressing vs Petroleum Ointment for Scar Appearance After Dermatologic Surgery: A Randomized Clinical Trial. JAMA Dermatol. 2025 Dec 1;161(12):1246-1251. doi: 10.1001/jamadermatol.2025.4051.

  PMID: 41123900 DERIVED

MeSH Terms

Conditions

Cicatrix; Skin Neoplasms; Surgical Wound; Patient Satisfaction; Patient Preference

Interventions

Bandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Results Point of Contact

• Title: Dr. Syril Keena T. Que
• Organization: Indiana University School of Medicine

ques@iu.edu

317-944-7744

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Dermatology

Model Details: Each patient will have the surgical scar treated with either type of intervention

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: November 16, 2022
• Study Start: October 17, 2022
• Primary Completion: October 16, 2023
• Study Completion: October 16, 2023
• Last Updated: December 11, 2024
• Results First Posted: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)