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

Disorder of Skin Donor Site Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04299126
• Other study ID #: 625/62
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 5, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: March 2020
• Source: Chulalongkorn University
• Contact: Pornanong Aramwit, Ph.D
• Phone: +66899217255
• Email: aramwit[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: February 15, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Disorder of Skin Donor Site
• Skin Diseases

Intervention

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

Locations

Country	Name	City	State
Thailand	Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound healing time	The day that the dressing will detach without painful.	not more than 28 days
Primary	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	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
Secondary	signs of infection	Signs of infection mean pain, swollen, red, and warn including pus on the wound.	not more than 28 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	adverse events	Adverse events will be observed. They will be recorded as "present" or "not present".	not more than 28 days
Secondary	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
Secondary	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
Secondary	blood urea nitrogen	Blood urea nitrogen (in mg/dl) after treatment will not be more than before treatment.	not more than 28 days
Secondary	serum creatinine	Serum creatinine (in mg/dl) after treatment will not be more than before treatment.	not more than 28 days