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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocolloid dressing | Device | A single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 days, 30 days, 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Health Physicians Dermatology Meridian Crossing | Carmel | Indiana | 46032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34993497 | Background | 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. | |
| 41123900 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) Hydrocolloid dressing: A single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2022 |
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Each patient will have the surgical scar treated with either type of intervention
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| 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 |
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. 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) Hydrocolloid dressing: A single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery |
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Mean | Standard Error | score on a scale | 7 days |
|
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| |||||||||||||||||||||||||||||||||||
| Primary | 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. | 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 | Posted | Mean | Standard Error | score on a scale | 30 days |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | 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 | Posted | Mean | Standard Error | score on a scale | 90 days |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Count of Participants | Participants | 7 days, 30 days, 90 days |
|
|
Adverse event data were collected over a 90-day period following the patient's excisional surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) Hydrocolloid dressing: A single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery | 0 | 72 | 0 | 72 | 60 | 72 |
| EG001 | 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. 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. | 0 | 74 | 0 | 74 | 40 | 74 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment | Assessed via surveys sent to all patients in the trial |
| |
| Surgical site pain | Skin and subcutaneous tissue disorders | Systematic Assessment | Assessed via surveys sent to all patients in the trial |
| |
| Required antibiotics | Skin and subcutaneous tissue disorders | Systematic Assessment | Assessed via surveys sent to all patients in the trial |
| |
| Wound dehiscence | Skin and subcutaneous tissue disorders | Systematic Assessment | Assessed via surveys sent to all patients in the trial |
| |
| Post-op bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment | Assessed via surveys sent to all patients in the trial |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Syril Keena T. Que | Indiana University School of Medicine | 317-944-7744 | ques@iu.edu |
| Oct 4, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 13, 2022 | Oct 4, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D012878 | Skin Neoplasms |
| D000072836 | Surgical Wound |
| D017060 | Patient Satisfaction |
| D057240 | Patient Preference |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D047070 | Bandages, Hydrocolloid |
| ID | Term |
|---|---|
| D001458 | Bandages |
| D004864 | Equipment and Supplies |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Patients - Color |
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| Surgeons - Color |
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| Patients - Texture |
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| Surgeons - Texture |
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| Patients - Scar Line |
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| Surgeons - Scar Line |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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