NCT02643680

Brief Summary

  1. 1.The wound healing time of STSG donor sites which are treated with the novel biocellulose wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.
  2. 2.The wound quality of STSG donor sites which are treated with the novel biocellulose wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.
  3. 3.The amounts of STSG donor site infection which are treated with the novel biocellulose wound dressing containing silk sericin and PHMB should not be more than Bactigras®.
  4. 4.The pain level of STSG donor sites which are treated with the novel biocellulose wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.
  5. 5.Adverse events which are occurred from the novel biocellulose wound dressing containing silk sericin and PHMB treatment for STSG donor sites and Bactigras® will be reported, if they occur.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

December 16, 2015

Last Update Submit

November 1, 2016

Conditions

WoundDisorder of Skin Donor Site

Keywords

BiocelluloseSilk sericinPolyhexamethylene biguanideSplit thickness skin graft donor site

Outcome Measures

Primary Outcomes (1)

  • Healing time

    The day that the dressing detaches by itself with no exudate and air contacted pain

    6 months

Secondary Outcomes (7)

  • Erythema and melanin level of wound

    1 year

  • Transepidermal water loss of wound

    1 year

  • Wound scar formation

    1 year

  • Signs of infection

    1 year

  • Swab test of infection wound

    1 year

  • +2 more secondary outcomes

Study Arms (2)

The novel biocellulose wound dressing

EXPERIMENTAL
Device: The novel biocellulose wound dressing

Bactigras

ACTIVE COMPARATOR
Device: Bactigras

Interventions

The novel biocellulose wound dressingDEVICE

The novel biocellulose dressing will used as a primary dressing at one half of the donor site. Then,the wound will be covered with 2 layers of gauze (secondary dressing) and 1 layer of bandage.The primary dressing will be unchanged until the wound healing (the day that the dressing detaches by itself with no exudate and air contacted pain) except signs of infection. The secondary dressing will be changed when excessive fluid appears.

Also known as: Biocellulose dressing containing silk sericin and PHMB
The novel biocellulose wound dressing
BactigrasDEVICE

Bactigras will used as a primary dressing at another one half of the donor site. Then,the wound will be covered with 2 layers of gauze (secondary dressing) and 1 layer of bandage.The primary dressing will be unchanged until the wound healing (the day that the dressing detaches by itself with no exudate and air contacted pain) except signs of infection. The secondary dressing will be changed when excessive fluid appears.

Also known as: Chlorhexidine acetate 0.5% in white soft paraffin
Bactigras

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have STSG donor site wounds on the thigh
  • Age more than 18 years old
  • Signed consent form

You may not qualify if:

  • Systemic infection
  • Known allergy or hypersensitivity reaction to silk sericin , PHMB, or chlorhexidine acetate
  • Known skin diseases
  • Known immunocompromised diseases
  • Known mental defect or schizophrenia
  • Pregnancy or lactation
  • Not follow all procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn Hospital

Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Pornanong Aramwit, Ph.D

    Chulalongkorn University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pornanong Aramwit, Ph.D

CONTACT

+66899217255aramwit@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 31, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2017

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

TH(1)