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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01539980
First received: February 17, 2012
Last updated: April 1, 2015
Last verified: April 2015
  Purpose
  1. Silk sericin wound dressing may reduce time for complete epithelialisation of split-thickness skin graft donor sites compared to Bactigras®.
  2. Silk sericin wound dressing may reduce pain level at split-thickness skin graft donor sites compared to Bactigras® .
  3. Silk sericin wound dressing may not cause split-thickness skin graft donor sites infection as compared to Bactigras®.
  4. Split-thickness skin graft donor sites which treat by silk sericin wound dressing may not cause significant adverse events.

Condition Intervention Phase
Late Complication From Skin Graft
Infection of Skin Donor Site
Impaired Wound Healing
Pain, Intractable
Device: Sericin scaffold
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment [ Time Frame: Within 14 days after operation ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Clinical Safety of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment [ Time Frame: Within 14 days after operation ] [ Designated as safety issue: Yes ]
    Number of patients with infected wound

  • Pain Levels of Wounds [ Time Frame: Within 14 days after operation ] [ Designated as safety issue: Yes ]
    Pain may occur on operation wounds. Visual analog scale is used by patients themselves for monitoring the pain level with 0 = no pain, 10 = worst possible pain.

  • Proinflammatory Cytokines (IL) [ Time Frame: Within 14 days after operation ] [ Designated as safety issue: Yes ]
    The proinflammatory cytokines from wound exudate will be measured for predicting the inflammatory level. ELISA kit is used.

  • Liver Enzyme (AST) [ Time Frame: Within 14 days after operation ] [ Designated as safety issue: Yes ]
    Large, open wound may absorb some materials from wound dressing. If those materials are toxic, liver enzyme (a major organ for elimination of any toxicities) will be increased.


Enrollment: 30
Study Start Date: August 2012
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sericin scaffold Device: Sericin scaffold
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

Detailed Description:

Split-thickness skin graft (STSG) is a surgical procedure to repair losses of skin by transferring of a section of healthy skin (donor site) to replace the damaged tissue in another area of the body (recipient site). However, the patients will have a new wound at donor sites which need appropriate wound dressing to increase healing and reduce complications. Since silk sericin can form a dressing which can accelerate wound healing process and protect wound from environment, the aim of this study is to investigate how well silk sericin wound dressing cures STSG donor sites by comparing to Bactigras® which is a commonly used paraffin-impregnated fine mesh gauze. Silk sericin wound dressing is a promising material which can shorten the treatment course and reduce pain for the patients who have donor sites. This study design is a single-center, randomized, open and paralleled positive control study.18-60- year-old patients of both genders who undergo STSG at anterolateral thigh in Division of plastic and reconstructive surgery, King Chulalongkorn Memorial Hospital from April 2012 to January 2013 will be recruited in the study. 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. The exclusion criteria are donor sites other than thigh or located at high risk of infection. Patients who are immunocompromised or mental defect, who are unlikely to comply with protocol or pregnant or lactating or known hypersensitivity to the investigational products are also excluded. All subjects sign the informed consents after an overall discussion of the protocol, its rationale and the potential risks. Donor sites are equally divided into 2 parts; upper and lower part of the leg. Using a random number table allocation, silk sericin wound dressing is randomly applied on one half and the other half will be covered by Bactigras®. Postoperatively, surgeons will observe all donor sites daily for treatment evaluation and any possible local adverse events without removing the primary dressings, except there is excessive fluid leakage or any sign of infection. Patients assess for pain level in every observations by using Visual Analog Scale. Time for complete epithelialisation is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. If there is any sign of infection such as swelling, edema, purulent discharge, bad odor, a swab evaluation at the suspected area will be done to find an appropriate management. Blood sample will be collected from patients pre- and postoperatively (with in 24h, day3 and before patient discharge) for CBC, blood glucose, electrolyte, hepatic and renal function analysis and proinflammatory cytokine measurement. This study may show any possible adverse events, both local and systemic effect, caused by silk sericin dressing. Proinflammatory cytokines patterns of the patients underwent STSG will be revealed in this study which may be relate to clinical outcomes.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539980

Locations
Thailand
Chulalongkorn Hospital
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
  More Information

No publications provided

Responsible Party: Pornanong Aramwit, Pharm.D., Ph.D, Associate Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01539980     History of Changes
Other Study ID Numbers: NRCT-2554-21
Study First Received: February 17, 2012
Results First Received: March 10, 2015
Last Updated: April 1, 2015
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Chulalongkorn University:
Sericin scaffold
Wound healing
Skin graft donor

Additional relevant MeSH terms:
Pain, Intractable
Skin Diseases, Infectious
Infection
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on August 03, 2015