Compare of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site

Mundipharma

Status: Completed

Conditions: Skin Graft

Treatments: Device: Petrolatum Gauze; Device: Allevyn Wound Dressing; Device: Betafoam Wound Dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT02543034

BTF14-KR-401

Details and patient eligibility

About

This study is a randomized, controlled, multi-centre, open-label, phase IV study.

Total 81 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam®, petrolatum gauze or Allevyn for donor site wounds after skin graft operation.

Enrollment: 105 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who is same as or more than 19 years old
2. Patients who will receive elective skin harvest operation
3. Patients who is in lateral thigh or buttock with donor site area from 50 to 150 cm2
4. Female patients who use method of contraception for the study
5. Patients who voluntarily sign the informed consent

Exclusion criteria

1. Patients who are pregnant
2. Patients who are known to have allergy to the dressing product including PVPI
3. Known hyperthyroidism or other thyroid dysfunction such as nodular thyroid goiter, endemic goiter and Hashimoto's thyroiditis or patients who receive radioiodine therapy
4. Co-morbidities which may adversely affect wound healing for example a patient with uncontrolled diabetes (HbA1c > 8%), chronic renal failure, autoimmune disease, or immunocompromised patient
5. Patients who receive anticoagulants, steroids or immunosuppressants
6. Patients who have signs and symptoms of infection on enrollment and adversely affect wound healing
7. Patients who have skin lesion such as Herpes zoster on donor site
8. Burn of >20% total body surface area
9. If the donor site had been harvested on a previous occasion
10. Patients who is limited cognitive ability
11. Patients who are participating in or will plan to participate in other clinical trials
12. Other various conditions that the investigators judge inappropriate for enrolment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Betafoam Wound Dressing

Experimental group

Description:

This contains 3% povidone iodine. Dressing will be routinely changed on day 3 and day 7, and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision.

Treatment:

Device: Betafoam Wound Dressing

Petrolatum Gauze

Active Comparator group

Description:

Dressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision.

Treatment:

Device: Petrolatum Gauze

Allevyn Wound Dressing

Active Comparator group

Description:

Allevyn adhesive wound dressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision.

Treatment:

Device: Allevyn Wound Dressing