Scar, Skin Scarring, Skin Cancer, Wound Heal, Wound of Skin, Surgical Wound, Patient Satisfaction, Patient Preference, Surgical Incision
Conditions
Keywords
scar, dermatologic surgery, wound healing, wound of skin, skin cancer, surgical incision, patient satisfaction, patient preference, cosmetic outcome, scar appearance
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.
Interventions
DEVICEHydrocolloid dressing
A single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery
OTHERPetrolatum 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.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Each patient will have the surgical scar treated with either type of intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Outcome | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complications | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 72 |
| 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. | 74 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 14 | 19 |
Baseline characteristics
| Characteristic | Petrolatum Jelly Dressing Arm | Total | Hydrocolloid Dressing Arm |
|---|---|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 13.5 | 61.9 years STANDARD_DEVIATION 12.9 | 63.8 years STANDARD_DEVIATION 11.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 73 Participants | 145 Participants | 72 Participants |
| Sex: Female, Male Female | 45 Participants | 85 Participants | 40 Participants |
| Sex: Female, Male Male | 29 Participants | 61 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 74 |
| other Total, other adverse events | 60 / 72 | 40 / 74 |
| serious Total, serious adverse events | 0 / 72 | 0 / 74 |
Outcome results
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Patients - Overall | 7.6 score on a scale | Standard Error 1.5 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Surgeons - Overall | 7.07 score on a scale | Standard Error 0.13 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Patients - Color | 7.5 score on a scale | Standard Error 1.5 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Surgeons - Color | 7.17 score on a scale | Standard Error 0.14 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Patients - Texture | 7.0 score on a scale | Standard Error 1.6 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Surgeons - Texture | 6.48 score on a scale | Standard Error 0.12 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Patients - Scar Line | 7.3 score on a scale | Standard Error 1.7 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Surgeons - Scar Line | 7.04 score on a scale | Standard Error 0.14 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Surgeons - Scar Line | 6.95 score on a scale | Standard Error 0.14 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Patients - Overall | 7.6 score on a scale | Standard Error 1.9 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Patients - Texture | 6.4 score on a scale | Standard Error 2.1 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Surgeons - Overall | 7.00 score on a scale | Standard Error 0.14 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Patients - Scar Line | 7.3 score on a scale | Standard Error 2.1 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Patients - Color | 7.5 score on a scale | Standard Error 1.8 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Surgeons - Texture | 6.30 score on a scale | Standard Error 0.12 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Surgeons - Color | 7.21 score on a scale | Standard Error 0.15 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Patients - Overall | 7.4 score on a scale | Standard Error 2 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Surgeons - Overall | 6.3 score on a scale | Standard Error 1.7 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Surgeons - Scar Line | 6.48 score on a scale | Standard Error 0.12 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Patients - Color | 7.1 score on a scale | Standard Error 1.8 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Surgeons - Color | 6.44 score on a scale | Standard Error 0.13 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Patients - Texture | 6.8 score on a scale | Standard Error 2 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Surgeons - Texture | 5.83 score on a scale | Standard Error 0.16 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Patients - Scar Line | 7.0 score on a scale | Standard Error 2.1 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Patients - Scar Line | 6.4 score on a scale | Standard Error 2.1 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Patients - Overall | 6.6 score on a scale | Standard Error 1.9 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Surgeons - Color | 5.97 score on a scale | Standard Error 0.14 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Surgeons - Overall | 6.00 score on a scale | Standard Error 1.8 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Surgeons - Texture | 5.80 score on a scale | Standard Error 0.15 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Surgeons - Scar Line | 6.30 score on a scale | Standard Error 0.12 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Patients - Texture | 6.4 score on a scale | Standard Error 2 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Patients - Color | 6.6 score on a scale | Standard Error 1.8 |
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Patients - Color | 7.1 score on a scale | Standard Error 1.8 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Patients - Overall | 8.2 score on a scale | Standard Error 1.8 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Surgeons - Color | 6.44 score on a scale | Standard Error 0.13 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Patients - Scar Line | 8.1 score on a scale | Standard Error 1.9 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Patients - Texture | 8.1 score on a scale | Standard Error 1.7 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Surgeons - Overall | 7.94 score on a scale | Standard Error 0.12 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Surgeons - Texture | 8.28 score on a scale | Standard Error 0.11 |
| Hydrocolloid Dressing Arm | Cosmetic Outcome | Surgeons - Scar Line | 7.89 score on a scale | Standard Error 0.13 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Surgeons - Scar Line | 7.86 score on a scale | Standard Error 0.13 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Patients - Scar Line | 7.9 score on a scale | Standard Error 2.1 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Patients - Overall | 8.1 score on a scale | Standard Error 1.6 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Surgeons - Overall | 7.92 score on a scale | Standard Error 0.12 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Patients - Color | 6.6 score on a scale | Standard Error 1.8 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Surgeons - Color | 5.97 score on a scale | Standard Error 0.14 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Patients - Texture | 7.8 score on a scale | Standard Error 2 |
| Petrolatum Jelly Dressing Arm | Cosmetic Outcome | Surgeons - Texture | 8.14 score on a scale | Standard Error 0.12 |
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
Time frame: 7 days, 30 days, 90 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hydrocolloid Dressing Arm | Number of Participants With Complications | Surgical site pain | 14 Participants |
| Hydrocolloid Dressing Arm | Number of Participants With Complications | Wound dehiscence | 4 Participants |
| Hydrocolloid Dressing Arm | Number of Participants With Complications | Required antibiotics | 0 Participants |
| Hydrocolloid Dressing Arm | Number of Participants With Complications | Post-op bleeding | 13 Participants |
| Hydrocolloid Dressing Arm | Number of Participants With Complications | Itching | 29 Participants |
| Petrolatum Jelly Dressing Arm | Number of Participants With Complications | Post-op bleeding | 5 Participants |
| Petrolatum Jelly Dressing Arm | Number of Participants With Complications | Itching | 28 Participants |
| Petrolatum Jelly Dressing Arm | Number of Participants With Complications | Surgical site pain | 7 Participants |
| Petrolatum Jelly Dressing Arm | Number of Participants With Complications | Required antibiotics | 0 Participants |
| Petrolatum Jelly Dressing Arm | Number of Participants With Complications | Wound dehiscence | 0 Participants |