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

Chulalongkorn University

Status: Unknown

Conditions: Disorder of Skin Donor Site

Treatments: Device: commercial wound dressing; Device: high absorption pad for blood and pus

Study type: Interventional

Funder types: Other

Identifiers

NCT04299126

625/62

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

24 participants in 2 patient groups

high absorption pad for blood and pus

Experimental group

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.

Treatment:

Device: high absorption pad for blood and pus

commercial wound dressing

Active Comparator group

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.

Treatment:

Device: commercial wound dressing