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

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

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.

Study Overview

• Status: Unknown
• Conditions: Wound; Disorder of Skin Donor Site
• Intervention / Treatment: Device: The novel biocellulose wound dressing; Device: Bactigras

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Recruiting
    • Chulalongkorn Hospital
    • Principal Investigator: Pornanong Aramwit, Ph.D.
    • Contact: Pornanong Aramwit, Ph.D.; Phone Number: +66-89-9217255; Email: aramwit@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The novel biocellulose wound dressing	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.; Other Names: Biocellulose dressing containing silk sericin and PHMB
Active Comparator: Bactigras	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.; Other Names: Chlorhexidine acetate 0.5% in white soft paraffin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing time	The day that the dressing detaches by itself with no exudate and air contacted pain	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events		1 year
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
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
Wound scar formation	Vancouver scar scale at healing day, 1, 3,and 6 months after healing	1 year
Signs of infection	Signs of infection: swelling, redness, bad odor, purulent discharge everyday	1 year
Swab test of infection wound	Swab evaluation when signs of infection observes	1 year
Pain score	Visual analogue scale	6 months

Collaborators and Investigators

• Sponsor: Chulalongkorn University
• Investigators: Principal Investigator: Pornanong Aramwit, Ph.D, Chulalongkorn University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Estimate): November 3, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Polyhexamethylene biguanide; Biocellulose; Silk sericin; Split thickness skin graft donor site
• Additional Relevant MeSH Terms: Wounds and Injuries; Skin Diseases; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: Med CU IRB 242/58