Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment

Sponsor

Indiana University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05618912

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scar Skin Scarring Skin Cancer Wound Heal Wound of Skin Surgical Wound Patient Satisfaction Patient Preference Surgical Incision	Device: Hydrocolloid dressing Other: Petrolatum jelly dressing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Each patient will have the surgical scar treated with either type of interventionEach patient will have the surgical scar treated with either type of intervention

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 17, 2022

Anticipated Primary Completion Date :

Aug 17, 2023

Anticipated Study Completion Date :

Aug 17, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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)	Device: Hydrocolloid dressing A single hydrocolloid dressing will be applied to the surgical site for 7 days following dermatologic surgery
Active Comparator: 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.	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.

Arm

Intervention/Treatment

Experimental: 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)

Device: Hydrocolloid dressing

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

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

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.
Cosmetic outcome [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.
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

Complication rate [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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