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

Phase 2

• Conditions: Wound; Disorder of Skin Donor Site
• Interventions: Device: The novel biocellulose wound dressing; Device: Bactigras

• Registration Number: NCT02643680
• Lead Sponsor: Chulalongkorn University

Brief 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.

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 Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-31
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-03
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The novel biocellulose wound dressing	The novel biocellulose wound dressing	-
Bactigras	Bactigras	-

Primary Outcome Measures

Name	Time	Method
Healing time	6 months	The day that the dressing detaches by itself with no exudate and air contacted pain

Secondary Outcome Measures

Name	Time	Method
Erythema and melanin level of wound	1 year	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
Swab test of infection wound	1 year	Swab evaluation when signs of infection observes
Pain score	6 months	Visual analogue scale
Wound scar formation	1 year	Vancouver scar scale at healing day, 1, 3,and 6 months after healing
Signs of infection	1 year	Signs of infection: swelling, redness, bad odor, purulent discharge everyday
Transepidermal water loss of wound	1 year	Transepidermal water loss by using Cutometer® with tewameter mode (Courage+Khazaka electronic GmbH, Germany) at healing day, 1, 3,and 6 months after healing
Adverse events	1 year

Trial Locations

Locations (1)

Chulalongkorn Hospital; 🇹🇭 Bangkok, Thailand