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

NCT ID: NCT04299126

Last Updated: 2020-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-05

Study Completion Date

2021-02-15

Brief Summary

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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

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Conditions

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Disorder of Skin Donor Site

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

high absorption pad for blood and pus

Intervention Type DEVICE

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 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.

Group Type ACTIVE_COMPARATOR

commercial wound dressing

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Pornanong Aramwit, Pharm.D., Ph.D

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Bangkok, , Thailand

Site Status

Countries

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Thailand

Central Contacts

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Pornanong Aramwit, Ph.D

Role: CONTACT

+66899217255

Other Identifiers

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625/62

Identifier Type: -

Identifier Source: org_study_id

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