Clinical trial NCT02643680: Clinical Study of Biocellulose Wound Dressing Containing Silk Sericin and PHMB for STSG Donor Sites
Official title: Clinical Efficacy of the Novel Biocellulose Wound Dressing Containing Silk Sericin and Polyhexamethylene Biguanide for Split-thickness Skin Graft Donor Sites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Wound
Disorder of Skin Donor Site
Keywords: Biocellulose
Silk sericin
Polyhexamethylene biguanide
Split thickness skin graft donor site
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Healing time
timeFrame: 6 months
Secondary outcomes:
measure: Erythema and melanin level of wound
timeFrame: 1 year
measure: Transepidermal water loss of wound
timeFrame: 1 year
measure: Wound scar formation
timeFrame: 1 year
measure: Signs of infection
timeFrame: 1 year
measure: Swab test of infection wound
timeFrame: 1 year
measure: Pain score
timeFrame: 6 months
measure: Adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
Study officials:
affiliation: Chulalongkorn University
name: Pornanong Aramwit, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: