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

Efficacy and Safety of High Absorption Pad for Blood and Pus With Natural Antimicrobial Agent in Split-thickness Skin Graft Donor Site Wound

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.

Study Overview

• Status: Unknown
• Conditions: Disorder of Skin Donor Site
• Intervention / Treatment: Device: high absorption pad for blood and pus; Device: commercial wound dressing

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pornanong Aramwit, Ph.D; Phone Number: +66899217255; Email: aramwit@gmail.com

Study Locations

• Thailand
  • Bangkok, Thailand, 10310
    • Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high absorption pad for blood and pus; 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; 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.
Active Comparator: commercial wound dressing; 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; Commercial wound dressing will be covered on half of split-thickness skin graft donor site wound until the wound has healed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 days after donor site wound was created
signs of infection	Signs of infection mean pain, swollen, red, and warn including pus on the wound.	not more than 28 days
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.	3 months
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.	3 months
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.	3 months
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.	3 months
adverse events	Adverse events will be observed. They will be recorded as "present" or "not present".	not more than 28 days
aspartate aminotransferase in serum	Aspartate aminotransferase in serum (in U/L) after treatment will not be more than before treatment.	not more than 28 days
alanine aminotransferase in serum	Alanine aminotransferase in serum (in U/L) after treatment will not be more than before treatment.	not more than 28 days
blood urea nitrogen	Blood urea nitrogen (in mg/dl) after treatment will not be more than before treatment.	not more than 28 days
serum creatinine	Serum creatinine (in mg/dl) after treatment will not be more than before treatment.	not more than 28 days

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 5, 2020
• Primary Completion (Anticipated): January 30, 2021
• Study Completion (Anticipated): February 15, 2021

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 625/62

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No