ScarNCT05618912

Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment

A study testing Hydrocolloid dressing and Petrolatum jelly dressing in people with Scar and Skin Scarring, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Scar, Skin Scarring, Skin Cancer
What is being tested?: Hydrocolloid dressing and Petrolatum jelly dressing
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 146 participants
Where: 1 siteUnited States
Study dates: 17 Oct 2022to 16 Oct 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

IU Health Physicians Dermatology Meridian Crossing
Carmel, Indiana, 46032

Other trials in United States

About this study

Official title: 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.

Conditions: Scar, Skin Scarring, Skin Cancer, Wound Heal, Wound of Skin, Surgical Wound
Being tested: Hydrocolloid dressing, Petrolatum jelly dressing
Keywords: scar, dermatologic surgery, wound healing, wound of skin, skin cancer, surgical incision, patient satisfaction, patient preference, cosmetic outcome, scar appearance
Medical subject headings: Cicatrix, Skin Neoplasms, Surgical Wound, Patient Satisfaction, Patient Preference

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hydrocolloid dressingDevice
A single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery
Petrolatum jelly dressingOther
The patient with the control wound will be covered with petrolatum jelly during this time period, which has to be re-applied daily.

Study groups in NCT05618912
Study group	Role	What they receive
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) Receives: 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. Receives: Other: Petrolatum jelly dressing

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 90 days

Secondary outcomes (1)

Number of Participants With Complications
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
Measured: 7 days, 30 days, 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 202216 Oct 2023

First posted16 Nov 2022
Study start17 Oct 2022
Primary completion16 Oct 2023
Study completion16 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ScarStudies of the same condition, open and under way.
More trials run by Indiana UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Each patient will have the surgical scar treated with either type of intervention
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 146 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05618912
Sponsor's protocol ID: 15768
Status last verified: Dec 2024
First submitted: 23 Oct 2022
Last updated: 11 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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.
PubMed 34993497
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.
PubMed 41123900

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05618912
Acronym / sponsor ID: 15768
Conditions: Scar, Skin Scarring, Skin Cancer, Wound Heal, Wound of Skin, Surgical Wound
Keywords: scar, dermatologic surgery, wound healing, wound of skin, skin cancer, surgical incision, patient satisfaction, patient preference
Study type: Interventional
Recruitment status: Completed
Enrolment: 146 participants (actual)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: 17 Oct 2022 (actual)
Primary completion: 16 Oct 2023 (actual)
Study completion: 16 Oct 2023 (actual)
First posted: 16 Nov 2022 (actual)
Results: Posted 11 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2
Model description: Each patient will have the surgical scar treated with either type of intervention

Arm	Type	Receives
hydrocolloid dressing arm	Experimental	Device: Hydrocolloid dressingAfter 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)
Petrolatum jelly dressing arm	Active comparator	Other: Petrolatum jelly dressingand 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hydrocolloid dressingA single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery	Device	hydrocolloid dressing arm
Petrolatum jelly dressingThe patient with the control wound will be covered with petrolatum jelly during this time period, which has to be re-applied daily.	Other	Petrolatum jelly dressing arm

Primary outcome

Cosmetic Outcome
Time frame: 7 days
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.
Cosmetic Outcome
Time frame: 30 days
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.
Cosmetic Outcome
Time frame: 90 days
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.

1 secondary outcome

Number of Participants With Complications
Time frame: 7 days, 30 days, 90 days

Results and safety

Results posted to the registry on 11 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hydrocolloid Dressing Arm	72	58
Petrolatum Jelly Dressing Arm	74	55

Primary outcome: Cosmetic Outcome

Time frame: 7 days. Mean (Standard Error). Unit: score on a scale

Measure	Hydrocolloid Dressing Arm n = 64	Petrolatum Jelly Dressing Arm n = 65
Patients - Overall	7.4 (2.0)	6.6 (1.9)
Surgeons - Overall	6.3 (1.7)	6.00 (1.8)
Patients - Color	7.1 (1.8)	6.6 (1.8)
Surgeons - Color	6.44 (0.13)	5.97 (0.14)
Patients - Texture	6.8 (2.0)	6.4 (2.0)
Surgeons - Texture	5.83 (0.16)	5.80 (0.15)
Patients - Scar Line	7.0 (2.1)	6.4 (2.1)
Surgeons - Scar Line	6.48 (0.12)	6.30 (0.12)

Population analysed: The above numbers reflect the number of patients who responded at 7-day postoperative followup and is smaller than the original number of participants in each arm due to lack of response by some participants

Primary outcome: Cosmetic Outcome

Time frame: 30 days. Mean (Standard Error). Unit: score on a scale

Measure	Hydrocolloid Dressing Arm n = 64	Petrolatum Jelly Dressing Arm n = 60
Patients - Overall	7.6 (1.5)	7.6 (1.9)
Surgeons - Overall	7.07 (0.13)	7.00 (0.14)
Patients - Color	7.5 (1.5)	7.5 (1.8)
Surgeons - Color	7.17 (0.14)	7.21 (0.15)
Patients - Texture	7.0 (1.6)	6.4 (2.1)
Surgeons - Texture	6.48 (0.12)	6.30 (0.12)
Patients - Scar Line	7.3 (1.7)	7.3 (2.1)
Surgeons - Scar Line	7.04 (0.14)	6.95 (0.14)

Population analysed: The above numbers reflect the number of patients who responded at 30-day postoperative followup and is smaller than the original number of participants in each arm and the number of participants analyzed at 7-day followup due to lack of response by some participants

Primary outcome: Cosmetic Outcome

Time frame: 90 days. Mean (Standard Error). Unit: score on a scale

Measure	Hydrocolloid Dressing Arm n = 58	Petrolatum Jelly Dressing Arm n = 55
Patients - Overall	8.2 (1.8)	8.1 (1.6)
Surgeons - Overall	7.94 (0.12)	7.92 (0.12)
Patients - Color	7.1 (1.8)	6.6 (1.8)
Surgeons - Color	6.44 (0.13)	5.97 (0.14)
Patients - Texture	8.1 (1.7)	7.8 (2.0)
Surgeons - Texture	8.28 (0.11)	8.14 (0.12)
Patients - Scar Line	8.1 (1.9)	7.9 (2.1)
Surgeons - Scar Line	7.89 (0.13)	7.86 (0.13)

Population analysed: The above numbers reflect the number of patients who responded at 90-day postoperative followup and is smaller than the number of participants initially enrolled and the number analyzed at 7-day and 30-day followup due to lack of response by some participants

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected over a 90-day period following the patient's excisional surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hydrocolloid Dressing Arm	0 of 72 (0%)	60 of 72 (83.3%)	0 of 72
Petrolatum Jelly Dressing Arm	0 of 74 (0%)	40 of 74 (54.1%)	0 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34993497Holmes 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.
Derived from this study: PubMed 41123900Bell 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Hydrocolloid dressing and Petrolatum jelly dressing in people with Scar and Skin Scarring, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cosmetic Outcome (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05618912, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.