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Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment

NCT ID: NCT05618912

Last Updated: 2024-12-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-17

Study Completion Date

2023-10-16

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.

Detailed Description

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Conditions

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

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each patient will have the surgical scar treated with either type of intervention
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

Hydrocolloid dressing

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Petrolatum jelly dressing

Intervention Type OTHER

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

Interventions

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Hydrocolloid dressing

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

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Syril Keena Que

Assistant Professor of Clinical Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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IU Health Physicians Dermatology Meridian Crossing

Carmel, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 34993497 (View on PubMed)

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 Oct 22. doi: 10.1001/jamadermatol.2025.4051. Online ahead of print.

Reference Type DERIVED
PMID: 41123900 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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15768

Identifier Type: -

Identifier Source: org_study_id