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Efficacy and Safety of High Absorption Pad in Split-thickness Skin Graft Donor Site Wound

Primary Purpose

Disorder of Skin Donor Site

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
high absorption pad for blood and pus
commercial wound dressing
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Skin Donor Site

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high absorption pad for blood and pus

commercial wound dressing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

wound healing time
The day that the dressing will detach without painful.
amounts of secondary gauze dressing
The amounts of secondary gauze dressing that will be changed because of blood over capacity.

Secondary Outcome Measures

pain score
Pain score will be evaluated using visual analogue scale. The 0 and 10 scores mean no pain and very pain, respectively. Higher score means more painful.
signs of infection
Signs of infection mean pain, swollen, red, and warn including pus on the wound.
scar melanin index
Scar melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
scar erythema index
Scar erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
transepidermal water loss index
Transepidermal water loss index of scar will be measured using Cutometer (Tewameter). There is no unit. Higher value mean higher risk of unhealthy scar.
scar quality
Scar quality will be evaluated using vancouver scar scale. The 0 and 13 scores mean high scar quality and low scar quality , respectively. Higher score means low scar quality.
adverse events
Adverse events will be observed. They will be recorded as "present" or "not present".
aspartate aminotransferase in serum
Aspartate aminotransferase in serum (in U/L) after treatment will not be more than before treatment.
alanine aminotransferase in serum
Alanine aminotransferase in serum (in U/L) after treatment will not be more than before treatment.
blood urea nitrogen
Blood urea nitrogen (in mg/dl) after treatment will not be more than before treatment.
serum creatinine
Serum creatinine (in mg/dl) after treatment will not be more than before treatment.

Full Information

First Posted
March 5, 2020
Last Updated
March 5, 2020
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT04299126
Brief Title
Efficacy and Safety of High Absorption Pad in Split-thickness Skin Graft Donor Site Wound
Official Title
Efficacy and Safety of High Absorption Pad for Blood and Pus With Natural Antimicrobial Agent in Split-thickness Skin Graft Donor Site Wound
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 5, 2020 (Anticipated)
Primary Completion Date
January 30, 2021 (Anticipated)
Study Completion Date
February 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Skin Donor Site

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high absorption pad for blood and pus
Arm Type
Experimental
Arm Description
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.
Arm Title
commercial wound dressing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
high absorption pad for blood and pus
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
commercial wound dressing
Intervention Description
Commercial wound dressing will be covered on half of split-thickness skin graft donor site wound until the wound has healed.
Primary Outcome Measure Information:
Title
wound healing time
Description
The day that the dressing will detach without painful.
Time Frame
not more than 28 days
Title
amounts of secondary gauze dressing
Description
The amounts of secondary gauze dressing that will be changed because of blood over capacity.
Time Frame
not more than 28 days
Secondary Outcome Measure Information:
Title
pain score
Description
Pain score will be evaluated using visual analogue scale. The 0 and 10 scores mean no pain and very pain, respectively. Higher score means more painful.
Time Frame
5 days after donor site wound was created
Title
signs of infection
Description
Signs of infection mean pain, swollen, red, and warn including pus on the wound.
Time Frame
not more than 28 days
Title
scar melanin index
Description
Scar melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Time Frame
3 months
Title
scar erythema index
Description
Scar erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
Time Frame
3 months
Title
transepidermal water loss index
Description
Transepidermal water loss index of scar will be measured using Cutometer (Tewameter). There is no unit. Higher value mean higher risk of unhealthy scar.
Time Frame
3 months
Title
scar quality
Description
Scar quality will be evaluated using vancouver scar scale. The 0 and 13 scores mean high scar quality and low scar quality , respectively. Higher score means low scar quality.
Time Frame
3 months
Title
adverse events
Description
Adverse events will be observed. They will be recorded as "present" or "not present".
Time Frame
not more than 28 days
Title
aspartate aminotransferase in serum
Description
Aspartate aminotransferase in serum (in U/L) after treatment will not be more than before treatment.
Time Frame
not more than 28 days
Title
alanine aminotransferase in serum
Description
Alanine aminotransferase in serum (in U/L) after treatment will not be more than before treatment.
Time Frame
not more than 28 days
Title
blood urea nitrogen
Description
Blood urea nitrogen (in mg/dl) after treatment will not be more than before treatment.
Time Frame
not more than 28 days
Title
serum creatinine
Description
Serum creatinine (in mg/dl) after treatment will not be more than before treatment.
Time Frame
not more than 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Systemic infection Chronic skin diseases Immune deficiency Allergic to cellulose, chitosan, sericin, and chlorhexidine Psychotic disorders Pregnancy or breast feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pornanong Aramwit, Ph.D
Phone
+66899217255
Email
aramwit@gmail.com
Facility Information:
Facility Name
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
City
Bangkok
ZIP/Postal Code
10310
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of High Absorption Pad in Split-thickness Skin Graft Donor Site Wound

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