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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Sericin scaffold
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Late Complication From Skin Graft focused on measuring Sericin scaffold, Wound healing, Skin graft donor

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chulalongkorn Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sericin scaffold

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical Safety of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment
Number of patients with infected wound
Pain Levels of Wounds
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)
The proinflammatory cytokines from wound exudate will be measured for predicting the inflammatory level. ELISA kit is used.
Liver Enzyme (AST)
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.

Full Information

First Posted
February 17, 2012
Last Updated
April 1, 2015
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT01539980
Brief Title
Clinical Study on Silk Sericin Wound Dressing for Split-thickness Skin Graft Donor Sites Treatment
Official Title
Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Late Complication From Skin Graft, Infection of Skin Donor Site, Impaired Wound Healing, Pain, Intractable
Keywords
Sericin scaffold, Wound healing, Skin graft donor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sericin scaffold
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Sericin scaffold
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment
Description
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.
Time Frame
Within 14 days after operation
Secondary Outcome Measure Information:
Title
Clinical Safety of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment
Description
Number of patients with infected wound
Time Frame
Within 14 days after operation
Title
Pain Levels of Wounds
Description
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.
Time Frame
Within 14 days after operation
Title
Proinflammatory Cytokines (IL)
Description
The proinflammatory cytokines from wound exudate will be measured for predicting the inflammatory level. ELISA kit is used.
Time Frame
Within 14 days after operation
Title
Liver Enzyme (AST)
Description
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.
Time Frame
Within 14 days after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Chulalongkorn Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

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

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