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

Wound Clinical Trial

Official title:

Clinical Efficacy of the Novel Biocellulose Wound Dressing Containing Silk Sericin and Polyhexamethylene Biguanide for Split-thickness Skin Graft Donor Sites

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02643680
• Other study ID #: Med CU IRB 242/58
• Status: Recruiting
• Phase: Phase 2
• First received: December 16, 2015
• Last updated: November 1, 2016
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: November 2016
• Source: Chulalongkorn University
• Contact: Pornanong Aramwit, Ph.D
• Phone: +66899217255
• Email: aramwit[@]gmail.com
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: November 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disorder of Skin Donor Site
• Skin Diseases
• Wound
• Wounds and Injuries

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Thailand	Chulalongkorn Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing time	The day that the dressing detaches by itself with no exudate and air contacted pain	6 months	Yes
Secondary	Erythema and melanin level of wound	Erythema and melanin level by using Cutometer® with mexameter mode (Courage+Khazaka electronic GmbH, Germany) at healing day, 1, 3,and 6 months after healing	1 year	Yes
Secondary	Transepidermal water loss of wound	Transepidermal water loss by using Cutometer® with tewameter mode (Courage+Khazaka electronic GmbH, Germany) at healing day, 1, 3,and 6 months after healing	1 year	Yes
Secondary	Wound scar formation	Vancouver scar scale at healing day, 1, 3,and 6 months after healing	1 year	Yes
Secondary	Signs of infection	Signs of infection: swelling, redness, bad odor, purulent discharge everyday	1 year	Yes
Secondary	Swab test of infection wound	Swab evaluation when signs of infection observes	1 year	Yes
Secondary	Pain score	Visual analogue scale	6 months	Yes
Secondary	Adverse events		1 year	Yes