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OpenTrials
Completed

NCT Number: NCT05618912

Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult > 18 years of age
  • Linear scars
  • Patients underwent conventional excision or Mohs micrographic surgery for primary cutaneous cancer or other cutaneous condition that required surgical intervention

Exclusion criteria

  • Scar localization on acral or hair bearing sites
  • Patients unable to converse in English
  • Patients requiring flap or graft for closure of wound
  • History of allergy to adhesives
  • Patient using topical chemotherapy agents on the surgical site or planning to start it within 3 months after surgery
  • Use of hydrocolloid dressings for post-operative wound care in the past

Treatment and study plan

Hydrocolloid dressing

Device

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

Petrolatum jelly dressing

Other

The patient with the control wound will be covered with petrolatum jelly during this time period, which has to be re-applied daily.

Primary outcomes

  1. Cosmetic Outcome

    Time frame: 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.

  2. Cosmetic Outcome

    Time frame: 30 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.

  3. Cosmetic Outcome

    Time frame: 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 outcomes

  1. Number of Participants With Complications

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 16, 2022
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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