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

Skin Graft Clinical Trial

Official title:

Randomized, Controlled, Phase IV Study of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02543034
• Other study ID #: BTF14-KR-401
• Status: Completed
• Phase: N/A
• First received: August 31, 2015
• Last updated: November 5, 2017
• Start date: March 16, 2016
• Est. completion date: May 2017

Study information

• Verified date: November 2017
• Source: Mundipharma Korea Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: May 2017
• Est. primary completion date: April 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Graft

Intervention

Device:
• Betafoam Wound Dressing
Foam dressing including Betadine iodine
• Petrolatum Gauze
Gauze dressing
• Allevyn Wound Dressing
Foam dressing

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Korea Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy as measured by speed of wound healing	Days needed for complete skin epithelialization in donor site wounds through routine swab culture (1 and 3 days) and visual assessment of wounds	6 months
Secondary	Efficacy as measured by adverse event collection		6 months