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OpenTrials
Completed

NCT Number: NCT02543034

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

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.

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Key information

Conditions

Skin Graft

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Patients who are pregnant
  • Patients who are known to have allergy to the dressing product including PVPI
  • Known hyperthyroidism or other thyroid dysfunction such as nodular thyroid goiter, endemic goiter and Hashimoto's thyroiditis or patients who receive radioiodine therapy
  • 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
  • Patients who receive anticoagulants, steroids or immunosuppressants
  • Patients who have signs and symptoms of infection on enrollment and adversely affect wound healing
  • Patients who have skin lesion such as Herpes zoster on donor site
  • Burn of >20% total body surface area
  • If the donor site had been harvested on a previous occasion
  • Patients who is limited cognitive ability
  • Patients who are participating in or will plan to participate in other clinical trials
  • Other various conditions that the investigators judge inappropriate for enrolment

Treatment and study plan

Betafoam Wound Dressing

Device

Foam dressing including Betadine iodine

Other names: Betafoam

Petrolatum Gauze

Device

Gauze dressing

Allevyn Wound Dressing

Device

Foam dressing

Other names: Allevyn

Primary outcomes

  1. Efficacy as measured by speed of wound healing

    Time frame: 6 months

    Days needed for complete skin epithelialization in donor site wounds through routine swab culture (1 and 3 days) and visual assessment of wounds

Secondary outcomes

  1. Efficacy as measured by adverse event collection

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mundipharma Korea Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 7, 2015
Registry last updated
Nov 7, 2017

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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