Patient Satisfaction Clinical Trial
Official title:
Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment: A Randomized Controlled Trial
NCT number | NCT05618912 |
Other study ID # | 15768 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 17, 2022 |
Est. completion date | October 16, 2023 |
Verified date | June 2024 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 159 |
Est. completion date | October 16, 2023 |
Est. primary completion date | October 16, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | IU Health Physicians Dermatology Meridian Crossing | Carmel | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 7 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. | 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. | 90 days | |
Secondary | Complication rate | 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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