Trial Outcomes & Findings for Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment (NCT NCT05618912)

Last Updated: 2024-12-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

146 participants

Primary outcome timeframe

7 days

Results posted on

2024-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	72	74
Overall Study COMPLETED	58	55
Overall Study NOT COMPLETED	14	19

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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.
Overall Study Lost to Follow-up	14	19

Baseline Characteristics

Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydrocolloid Dressing Arm n=72 Participants 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	Petrolatum Jelly Dressing Arm n=74 Participants 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.	Total n=146 Participants Total of all reporting groups
Age, Continuous	63.8 years STANDARD_DEVIATION 11.5 • n=5 Participants	61.3 years STANDARD_DEVIATION 13.5 • n=7 Participants	61.9 years STANDARD_DEVIATION 12.9 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	45 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	32 Participants n=5 Participants	29 Participants n=7 Participants	61 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants	73 Participants n=7 Participants	145 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: 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

Outcome measures

Outcome measures
Measure	Hydrocolloid Dressing Arm n=64 Participants 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	Petrolatum Jelly Dressing Arm n=65 Participants 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.
Cosmetic Outcome Surgeons - Scar Line	6.48 score on a scale Standard Error 0.12	6.30 score on a scale Standard Error 0.12
Cosmetic Outcome Patients - Overall	7.4 score on a scale Standard Error 2.0	6.6 score on a scale Standard Error 1.9
Cosmetic Outcome Surgeons - Overall	6.3 score on a scale Standard Error 1.7	6.00 score on a scale Standard Error 1.8
Cosmetic Outcome Patients - Color	7.1 score on a scale Standard Error 1.8	6.6 score on a scale Standard Error 1.8
Cosmetic Outcome Surgeons - Color	6.44 score on a scale Standard Error 0.13	5.97 score on a scale Standard Error 0.14
Cosmetic Outcome Patients - Texture	6.8 score on a scale Standard Error 2.0	6.4 score on a scale Standard Error 2.0
Cosmetic Outcome Surgeons - Texture	5.83 score on a scale Standard Error 0.16	5.80 score on a scale Standard Error 0.15
Cosmetic Outcome Patients - Scar Line	7.0 score on a scale Standard Error 2.1	6.4 score on a scale Standard Error 2.1

PRIMARY outcome

Timeframe: 30 days

Population: 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

Outcome measures

Outcome measures
Measure	Hydrocolloid Dressing Arm n=64 Participants 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	Petrolatum Jelly Dressing Arm n=60 Participants 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.
Cosmetic Outcome Patients - Overall	7.6 score on a scale Standard Error 1.5	7.6 score on a scale Standard Error 1.9
Cosmetic Outcome Surgeons - Overall	7.07 score on a scale Standard Error 0.13	7.00 score on a scale Standard Error 0.14
Cosmetic Outcome Surgeons - Color	7.17 score on a scale Standard Error 0.14	7.21 score on a scale Standard Error 0.15
Cosmetic Outcome Patients - Texture	7.0 score on a scale Standard Error 1.6	6.4 score on a scale Standard Error 2.1
Cosmetic Outcome Surgeons - Texture	6.48 score on a scale Standard Error 0.12	6.30 score on a scale Standard Error 0.12
Cosmetic Outcome Patients - Scar Line	7.3 score on a scale Standard Error 1.7	7.3 score on a scale Standard Error 2.1
Cosmetic Outcome Surgeons - Scar Line	7.04 score on a scale Standard Error 0.14	6.95 score on a scale Standard Error 0.14
Cosmetic Outcome Patients - Color	7.5 score on a scale Standard Error 1.5	7.5 score on a scale Standard Error 1.8

PRIMARY outcome

Timeframe: 90 days

Population: 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

Outcome measures

Outcome measures
Measure	Hydrocolloid Dressing Arm n=58 Participants 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	Petrolatum Jelly Dressing Arm n=55 Participants 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.
Cosmetic Outcome Patients - Overall	8.2 score on a scale Standard Error 1.8	8.1 score on a scale Standard Error 1.6
Cosmetic Outcome Surgeons - Color	6.44 score on a scale Standard Error 0.13	5.97 score on a scale Standard Error 0.14
Cosmetic Outcome Patients - Texture	8.1 score on a scale Standard Error 1.7	7.8 score on a scale Standard Error 2.0
Cosmetic Outcome Surgeons - Texture	8.28 score on a scale Standard Error 0.11	8.14 score on a scale Standard Error 0.12
Cosmetic Outcome Patients - Scar Line	8.1 score on a scale Standard Error 1.9	7.9 score on a scale Standard Error 2.1
Cosmetic Outcome Surgeons - Scar Line	7.89 score on a scale Standard Error 0.13	7.86 score on a scale Standard Error 0.13
Cosmetic Outcome Surgeons - Overall	7.94 score on a scale Standard Error 0.12	7.92 score on a scale Standard Error 0.12
Cosmetic Outcome Patients - Color	7.1 score on a scale Standard Error 1.8	6.6 score on a scale Standard Error 1.8

SECONDARY outcome

Timeframe: 7 days, 30 days, 90 days

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

Outcome measures

Outcome measures
Measure	Hydrocolloid Dressing Arm n=72 Participants 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	Petrolatum Jelly Dressing Arm n=74 Participants 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.
Number of Participants With Complications Itching	29 Participants	28 Participants
Number of Participants With Complications Surgical site pain	14 Participants	7 Participants
Number of Participants With Complications Required antibiotics	0 Participants	0 Participants
Number of Participants With Complications Wound dehiscence	4 Participants	0 Participants
Number of Participants With Complications Post-op bleeding	13 Participants	5 Participants

Adverse Events

Hydrocolloid Dressing Arm

Serious events: 0 serious events

Other events: 60 other events

Deaths: 0 deaths

Petrolatum Jelly Dressing Arm

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hydrocolloid Dressing Arm n=72 participants at risk 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	Petrolatum Jelly Dressing Arm n=74 participants at risk 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.
Skin and subcutaneous tissue disorders Itching	40.3% 29/72 • Number of events 29 • Adverse event data were collected over a 90-day period following the patient's excisional surgery	37.8% 28/74 • Number of events 28 • Adverse event data were collected over a 90-day period following the patient's excisional surgery
Skin and subcutaneous tissue disorders Surgical site pain	19.4% 14/72 • Number of events 14 • Adverse event data were collected over a 90-day period following the patient's excisional surgery	9.5% 7/74 • Number of events 7 • Adverse event data were collected over a 90-day period following the patient's excisional surgery
Skin and subcutaneous tissue disorders Required antibiotics	0.00% 0/72 • Adverse event data were collected over a 90-day period following the patient's excisional surgery	0.00% 0/74 • Adverse event data were collected over a 90-day period following the patient's excisional surgery
Skin and subcutaneous tissue disorders Wound dehiscence	5.6% 4/72 • Number of events 4 • Adverse event data were collected over a 90-day period following the patient's excisional surgery	0.00% 0/74 • Adverse event data were collected over a 90-day period following the patient's excisional surgery
Skin and subcutaneous tissue disorders Post-op bleeding	18.1% 13/72 • Number of events 13 • Adverse event data were collected over a 90-day period following the patient's excisional surgery	6.8% 5/74 • Number of events 5 • Adverse event data were collected over a 90-day period following the patient's excisional surgery

Additional Information

Dr. Syril Keena T. Que

Indiana University School of Medicine

Phone: 317-944-7744

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place