Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment

Patient Satisfaction Clinical Trial

Official title:

Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618912
• Other study ID #: 15768
• Status: Recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: August 17, 2024

Study information

• Verified date: October 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 17, 2024
• Est. primary completion date: August 17, 2024
• 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

Related Conditions & MeSH terms

• Cicatrix
• Patient Preference
• Patient Satisfaction
• Scar
• Skin Cancer
• Skin Neoplasms
• Skin Scarring
• Surgical Incision
• Surgical Wound
• Wound Heal
• Wound of Skin
• Wounds and Injuries

Intervention

Device:
• Hydrocolloid dressing
A single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery

Other:
• 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.

Locations

Country	Name	City	State
United States	IU Health Physicians Dermatology Meridian Crossing	Carmel	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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