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Clinical Study of Biocellulose Wound Dressing Containing Silk Sericin and PHMB for STSG Donor Sites

NCT ID: NCT02643680

Last Updated: 2016-11-03

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

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-11-30

Brief Summary

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1. The wound healing time of STSG donor sites which are treated with the novel biocellulose wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.
2. The wound quality of STSG donor sites which are treated with the novel biocellulose wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.
3. The amounts of STSG donor site infection which are treated with the novel biocellulose wound dressing containing silk sericin and PHMB should not be more than Bactigras®.
4. The pain level of STSG donor sites which are treated with the novel biocellulose wound dressing containing silk sericin and PHMB should be less or equal to Bactigras®.
5. Adverse events which are occurred from the novel biocellulose wound dressing containing silk sericin and PHMB treatment for STSG donor sites and Bactigras® will be reported, if they occur.

Detailed Description

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The goals of STSG donor site treatment are to accelerate wound healing, prevent infection, reduce pain, and maintain an optimal environment healing promotion. Biocellulose is an ultrafine fiber structure that can hold a large amount of water and has a cooling effect that decreases pain without causing an allergic reaction or irritation.Silk sericin (SS) can activate the growth of fibroblast cells which promote collagen type I production and accelerated wound healing without toxicity . Polyhexamethylene biguanide (PHMB) is a broad spectrum antimicrobial agent with high efficacy and low toxicity. Therefore, the combination of silk sericin and PHMB in biocellulose dressings would benefit STSG donor site wound treatment. The purpose of this study is to investigate the clinical efficacy of this dressing for STSG donor site wound treatment compared with Bactigras® (chlorhexidine acetate 0.5% in white soft paraffin), which is the standard dressing for this type of wound at King Chulalongkorn Memorial Hospital, by monitoring the time required for complete re-epithelization, wound quality, the rate of infection, pain, and the adverse events from December 2015 to November 2016. Thirty two subjects (more than 18 years) with STSG donor site at thigh will be recruited in this study. Block randomization will be used for separation half of eligible wound to cover with novel biocellulose wound dressing containing silk sericin and PHMB or Bactigras®. Wound healing time is the day that the dressing detaches by itself with no exudate and air contacted pain. Wound quality at 1,3,and 6 months will be measured in terms of erythema level, melanin level, transepidermal water loss by using Cutometer® and scar quality (vancouver scar scale). Sign of infection, pain (VAS score), hepatic and renal function will also be collected.

Conditions

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Wound Disorder of Skin Donor Site

Keywords

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Biocellulose Silk sericin Polyhexamethylene biguanide Split thickness skin graft 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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The novel biocellulose wound dressing

Group Type EXPERIMENTAL

The novel biocellulose wound dressing

Intervention Type DEVICE

The novel biocellulose dressing will used as a primary dressing at one half of the donor site. Then,the wound will be covered with 2 layers of gauze (secondary dressing) and 1 layer of bandage.The primary dressing will be unchanged until the wound healing (the day that the dressing detaches by itself with no exudate and air contacted pain) except signs of infection. The secondary dressing will be changed when excessive fluid appears.

Bactigras

Group Type ACTIVE_COMPARATOR

Bactigras

Intervention Type DEVICE

Bactigras will used as a primary dressing at another one half of the donor site. Then,the wound will be covered with 2 layers of gauze (secondary dressing) and 1 layer of bandage.The primary dressing will be unchanged until the wound healing (the day that the dressing detaches by itself with no exudate and air contacted pain) except signs of infection. The secondary dressing will be changed when excessive fluid appears.

Interventions

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The novel biocellulose wound dressing

The novel biocellulose dressing will used as a primary dressing at one half of the donor site. Then,the wound will be covered with 2 layers of gauze (secondary dressing) and 1 layer of bandage.The primary dressing will be unchanged until the wound healing (the day that the dressing detaches by itself with no exudate and air contacted pain) except signs of infection. The secondary dressing will be changed when excessive fluid appears.

Intervention Type DEVICE

Bactigras

Bactigras will used as a primary dressing at another one half of the donor site. Then,the wound will be covered with 2 layers of gauze (secondary dressing) and 1 layer of bandage.The primary dressing will be unchanged until the wound healing (the day that the dressing detaches by itself with no exudate and air contacted pain) except signs of infection. The secondary dressing will be changed when excessive fluid appears.

Intervention Type DEVICE

Other Intervention Names

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Biocellulose dressing containing silk sericin and PHMB Chlorhexidine acetate 0.5% in white soft paraffin

Eligibility Criteria

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Inclusion Criteria

* Patients who have STSG donor site wounds on the thigh
* Age more than 18 years old
* Signed consent form

Exclusion Criteria

* Systemic infection
* Known allergy or hypersensitivity reaction to silk sericin , PHMB, or chlorhexidine acetate
* Known skin diseases
* Known immunocompromised diseases
* Known mental defect or schizophrenia
* Pregnancy or lactation
* Not follow all procedure
Minimum Eligible Age

18 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

Principal Investigators

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Pornanong Aramwit, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chulalongkorn University

Locations

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Chulalongkorn Hospital

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Pornanong Aramwit, Ph.D

Role: CONTACT

Phone: +66899217255

Email: [email protected]

Facility Contacts

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Pornanong Aramwit, Ph.D.

Role: primary

Other Identifiers

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Med CU IRB 242/58

Identifier Type: -

Identifier Source: org_study_id