NCT04299126

Brief Summary

High absorption pad for blood and pus with natural antimicrobial agent or gauze dressing impregnated with paraffin, containing 0.5% chlorhexidine acetate (Bactigras) will be randomly covered on half of split-thickness skin graft donor site wound. The another will be cover on another half of split-thickness skin graft donor site wound. Then, they will be covered with gauzes and bandage. Time to wound healing, amounts of covered dressing gauzes, signs of infection, pain score, erythema index, melanin index, trans epidermal water loss index, and adverse events will be evaluated.

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
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

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

First Submitted

Initial submission to the registry

March 5, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

March 5, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

March 5, 2020

Last Update Submit

March 5, 2020

Conditions

Disorder of Skin Donor Site

Outcome Measures

Primary Outcomes (2)

  • wound healing time

    The day that the dressing will detach without painful.

    not more than 28 days

  • amounts of secondary gauze dressing

    The amounts of secondary gauze dressing that will be changed because of blood over capacity.

    not more than 28 days

Secondary Outcomes (11)

  • pain score

    5 days after donor site wound was created

  • signs of infection

    not more than 28 days

  • scar melanin index

    3 months

  • scar erythema index

    3 months

  • transepidermal water loss index

    3 months

  • +6 more secondary outcomes

Study Arms (2)

high absorption pad for blood and pus

EXPERIMENTAL

High absorption pad for blood and pus with natural antimicrobial agent composes of sericin and chitosan. It will be covered on half of split-thickness skin graft donor site wound until the wound has healed.

Device: high absorption pad for blood and pus

commercial wound dressing

ACTIVE COMPARATOR

Commercial wound dressing is gauze dressing impregnated with paraffin, containing 0.5% chlorhexidine acetate (Bactigras). It will be covered on half of split-thickness skin graft donor site wound until the wound has healed.

Device: commercial wound dressing

Interventions

high absorption pad for blood and pusDEVICE

High absorption pad for blood and pus will be covered on half of split-thickness skin graft donor site wound until the wound has healed.

high absorption pad for blood and pus
commercial wound dressingDEVICE

Commercial wound dressing will be covered on half of split-thickness skin graft donor site wound until the wound has healed.

commercial wound dressing

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Have split-thickness skin graft donor site wound on thigh
  • Age 18-60 years
  • Can read and write
  • Can follow the study protocol
  • Available on appointment date

You may not qualify if:

  • Systemic infection
  • Chronic skin diseases
  • Immune deficiency
  • Allergic to cellulose, chitosan, sericin, and chlorhexidine
  • Psychotic disorders
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity

Bangkok, 10310, Thailand

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Pornanong Aramwit, Ph.D

CONTACT

+66899217255aramwit@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
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

March 5, 2020

First Posted

March 6, 2020

Study Start

March 5, 2020

Primary Completion

January 30, 2021

Study Completion

February 15, 2021

Last Updated

March 6, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)