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

Not Applicable

• Conditions: Disorder of Skin Donor Site
• Interventions: Device: commercial wound dressing; Device: high absorption pad for blood and pus

• Registration Number: NCT04299126
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-05
• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-05
• Last Update Submitted: 2020-03-05
• Study First Posted: 2020-03-06
• Last Update Posted: 2020-03-06
• Primary Completion: 2021-01-30
• Study Completion: 2021-02-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
commercial wound dressing	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.
high absorption pad for blood and pus	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.

Primary Outcome Measures

Name	Time	Method
amounts of secondary gauze dressing	not more than 28 days	The amounts of secondary gauze dressing that will be changed because of blood over capacity.
wound healing time	not more than 28 days	The day that the dressing will detach without painful.

Secondary Outcome Measures

Name	Time	Method
scar erythema index	3 months	Scar erythema index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.
scar quality	3 months	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.
blood urea nitrogen	not more than 28 days	Blood urea nitrogen (in mg/dl) after treatment will not be more than before treatment.
signs of infection	not more than 28 days	Signs of infection mean pain, swollen, red, and warn including pus on the wound.
transepidermal water loss index	3 months	Transepidermal water loss index of scar will be measured using Cutometer (Tewameter). There is no unit. Higher value mean higher risk of unhealthy scar.
alanine aminotransferase in serum	not more than 28 days	Alanine aminotransferase in serum (in U/L) after treatment will not be more than before treatment.
adverse events	not more than 28 days	Adverse events will be observed. They will be recorded as "present" or "not present".
aspartate aminotransferase in serum	not more than 28 days	Aspartate aminotransferase in serum (in U/L) after treatment will not be more than before treatment.
serum creatinine	not more than 28 days	Serum creatinine (in mg/dl) after treatment will not be more than before treatment.
pain score	5 days after donor site wound was created	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.
scar melanin index	3 months	Scar melanin index will be measured using Cutometer (Mexameter). There is no unit. Higher value mean higher risk of post inflammatory reaction.

Trial Locations

Locations (1)

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity; 🇹🇭 Bangkok, Thailand