Clinical Study on Silk Sericin Wound Dressing for Split-thickness Skin Graft Donor Sites Treatment

NCT01539980 | Completed Phase 1 Results DMC

• 1 other identifier: NRCT-2554-21
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Silk sericin wound dressing may reduce time for complete epithelialisation of split-thickness skin graft donor sites compared to Bactigras®.
2. 2.Silk sericin wound dressing may reduce pain level at split-thickness skin graft donor sites compared to Bactigras® .
3. 3.Silk sericin wound dressing may not cause split-thickness skin graft donor sites infection as compared to Bactigras®.
4. 4.Split-thickness skin graft donor sites which treat by silk sericin wound dressing may not cause significant adverse events.

Conditions

Late Complication From Skin Graft; Infection of Skin Donor Site; Impaired Wound Healing; Pain, Intractable

Keywords

Sericin scaffold; Wound healing; Skin graft donor

Outcome Measures

Primary Outcomes (1)

• Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment

  Time for complete epithalization is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. The wounds completely close and without fluid leakage and are able to exposed to the environment without pain. This duration should not exceed than 14 days.

  Within 14 days after operation

Secondary Outcomes (4)

• Clinical Safety of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment

  Within 14 days after operation

• Pain Levels of Wounds

  Within 14 days after operation

• Proinflammatory Cytokines (IL)

  Within 14 days after operation

• Liver Enzyme (AST)

  Within 14 days after operation

Study Arms (1)

Sericin scaffold

EXPERIMENTAL

Device: Sericin scaffold

Interventions

Sericin scaffold DEVICE

Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith\&Nephew, London, UK) are applied on the other half of the skin graft donor site

Sericin scaffold

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 18-60 years
• Patients who require STSG such as burn, trauma, venous ulcers, or surgical removal of cutaneous malignancies etc.
• Patients whom surgeons assess that ready for undergoing STSG
• Sufficient normal skin at anterolateral thigh area for 1 or more STSG donor sites
• The thickness of donor sites fall between 0.15-0.45 mm (0.006-0.018 inches) and their sizes are at least 100 cm2
• Patients who are willing to participate in the trial and to sign the informed consent form.

You may not qualify if:

• Use others area for STSG donor sites other than thigh
• Donor sites are located at high risk of infection such as harvesting closed to current infective wound (excessive purulent discharge or bad odor)
• Patients who are immunocompromised or mental defect
• Patients who cannot or not willing to comply with the study protocol
• Known allergy or hypersensitivity reaction to silk sericin or chlorhexidine acetate
• Pregnancy or lactation

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Pain, Intractable

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Professor Pornanong Aramwit, Pharm.D., Ph.D.
• Organization: Faculty of Pharmaceutical Sciences, Chulalongkorn University

aramwit@gmail.com

+66899217255

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: February 28, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 2, 2015
• Results First Posted: April 2, 2015

Record last verified: 2015-04

Locations

TH (1)