NCT02543034

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

March 16, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2017

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

1.1 years

First QC Date

August 31, 2015

Last Update Submit

November 5, 2017

Conditions

Skin Graft

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Efficacy as measured by adverse event collection

    6 months

Study Arms (3)

Betafoam Wound Dressing

EXPERIMENTAL

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.

Device: Betafoam Wound Dressing

Petrolatum Gauze

ACTIVE COMPARATOR

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.

Device: Petrolatum Gauze

Allevyn Wound Dressing

ACTIVE COMPARATOR

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.

Device: Allevyn Wound Dressing

Interventions

Betafoam Wound DressingDEVICE

Foam dressing including Betadine iodine

Also known as: Betafoam
Betafoam Wound Dressing
Petrolatum GauzeDEVICE

Gauze dressing

Petrolatum Gauze
Allevyn Wound DressingDEVICE

Foam dressing

Also known as: Allevyn
Allevyn Wound Dressing

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

Study Officials

  • Jongwon Lee, Dr.

    Seoul St. Mary's Hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 7, 2015

Study Start

March 16, 2016

Primary Completion

April 14, 2017

Study Completion

May 1, 2017

Last Updated

November 7, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)