Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment

Not Applicable

Completed

• Conditions: Wound of Skin; Patient Preference; Surgical Incision; Patient Satisfaction; Skin Scarring; Skin Cancer; Wound Heal; Scar; Surgical Wound

• Registration Number: NCT05618912
• Lead Sponsor: Indiana University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-17
• Study First Submitted: 2022-10-23
• Study First Submitted QC: 2022-11-09
• Study First Posted: 2022-11-16
• Primary Completion: 2023-10-16
• Study Completion: 2023-10-16
• Results First Submitted: 2024-10-05
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-07
• Last Update Submitted: 2024-12-07
• Results First Posted: 2024-12-11
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cosmetic Outcome	90 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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IU Health Physicians Dermatology Meridian Crossing; 🇺🇸 Carmel, Indiana, United States