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Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment

Primary Purpose

Wound Heal, Wound Surgical, Donor Site Complication

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
wound dressing application
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Heal focused on measuring Wound dressing, Sericin, Collagen, Split-thickness skin graft donor site (STSG donor site)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients who have STSG donor site wounds on the thigh area
  • Age more than 18 years old
  • The split-thickness skin graft is harvested for the first time at the investigated area.
  • Patients who are able to communicate with the Thai language
  • Willingness to participate

Exclusion Criteria:

  • Patient with a mental disorder or immunocompromised diseases
  • Patients who cannot or not willing to follow the protocol
  • Known sensitivity or allergy to sericin, chlorhexidine, and collagen
  • Pregnancy or lactation

Sites / Locations

  • Chulalongkorn HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sericin dressing with collagen

Bactigras

Arm Description

Sericin dressing with collagen

Commercial dressing

Outcomes

Primary Outcome Measures

Time to complete healing
The number of days since starting treatment until the primary dressing can spontaneously detach from wound with full re-epithelialization (at least 95% re-epithelialization) without any drainage.

Secondary Outcome Measures

Pain score
Pain score evaluated by patient using visual analog scales (0-10)
Incidence of infection
The incidence of infection will be reported as "present" or "not present". Infection wound is wound which has purulent secretion or some of the inflammatory reactions (erythema, warmth, pain or tenderness, or induration) and has positive result from microbiological test.
Incidence of adverse effect
Adverse effects on hepatic function, renal function, and other adverse effects resulted from dressing application will be reported as "present" or "not present".
Vancouver scar scale (VSS)
Vancouver scar scale evaluated by clinician at 1, 3, and 6 months after complete wound healing
Patient scale of Patient and observer scar scale (POSAS)
Patient scale of Patient and observer scar scale (POSAS) evaluated by patients 6 months after complete wound healing
Erythema level
Erythema level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing
Melanin level
Melanin level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing
Trans-epidermal water loss (TEWL)
TEWL measured by using Tewameter® at 1, 3, and 6 months after complete wound healing
Skin hydration
Hydration level measured by using Corneometer® at 1, 3, and 6 months after complete wound healing
Skin elasticity
Elasticity parameters measured by using Cutometer® at 1, 3, and 6 months after complete wound healing

Full Information

First Posted
February 4, 2021
Last Updated
February 4, 2021
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT04743375
Brief Title
Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment
Official Title
Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To examine the efficacy and safety of sericin dressing with collagen in STSG donor site treatment comparing with Bactigras®. Around 30 patients will be enrolled in this study.
Detailed Description
Wounds are a public health problem found worldwide that associated with both clinical and economic burdens. Although several wound dressings are available, some limitations of those dressings still existed resulting in the need for new wound dressing development. The sericin dressing with collagen was developed to provide a moist environment and bioactive ingredients to the wound bed. To evaluate its efficacy and safety, the STSG donor sites of each patient will be divided into two equal areas. Each area will be randomly allocated into sericin dressing with collagen group or control group (Bactigras®). The outcomes will be collected to examine the efficacy and safety of sericin dressing with collagen in comparison with commercial dressing Bactigras®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Heal, Wound Surgical, Donor Site Complication
Keywords
Wound dressing, Sericin, Collagen, Split-thickness skin graft donor site (STSG donor site)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sericin dressing with collagen
Arm Type
Experimental
Arm Description
Sericin dressing with collagen
Arm Title
Bactigras
Arm Type
Active Comparator
Arm Description
Commercial dressing
Intervention Type
Other
Intervention Name(s)
wound dressing application
Intervention Description
Sericin dressing with collagen or Bactigras will be used as a primary dressing for treating the STSG donor site.
Primary Outcome Measure Information:
Title
Time to complete healing
Description
The number of days since starting treatment until the primary dressing can spontaneously detach from wound with full re-epithelialization (at least 95% re-epithelialization) without any drainage.
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Pain score
Description
Pain score evaluated by patient using visual analog scales (0-10)
Time Frame
42 days
Title
Incidence of infection
Description
The incidence of infection will be reported as "present" or "not present". Infection wound is wound which has purulent secretion or some of the inflammatory reactions (erythema, warmth, pain or tenderness, or induration) and has positive result from microbiological test.
Time Frame
42 days
Title
Incidence of adverse effect
Description
Adverse effects on hepatic function, renal function, and other adverse effects resulted from dressing application will be reported as "present" or "not present".
Time Frame
42 days
Title
Vancouver scar scale (VSS)
Description
Vancouver scar scale evaluated by clinician at 1, 3, and 6 months after complete wound healing
Time Frame
6 months
Title
Patient scale of Patient and observer scar scale (POSAS)
Description
Patient scale of Patient and observer scar scale (POSAS) evaluated by patients 6 months after complete wound healing
Time Frame
6 months
Title
Erythema level
Description
Erythema level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing
Time Frame
6 months
Title
Melanin level
Description
Melanin level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing
Time Frame
6 months
Title
Trans-epidermal water loss (TEWL)
Description
TEWL measured by using Tewameter® at 1, 3, and 6 months after complete wound healing
Time Frame
6 months
Title
Skin hydration
Description
Hydration level measured by using Corneometer® at 1, 3, and 6 months after complete wound healing
Time Frame
6 months
Title
Skin elasticity
Description
Elasticity parameters measured by using Cutometer® at 1, 3, and 6 months after complete wound healing
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have STSG donor site wounds on the thigh area Age more than 18 years old The split-thickness skin graft is harvested for the first time at the investigated area. Patients who are able to communicate with the Thai language Willingness to participate Exclusion Criteria: Patient with a mental disorder or immunocompromised diseases Patients who cannot or not willing to follow the protocol Known sensitivity or allergy to sericin, chlorhexidine, and collagen Pregnancy or lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pornanong Aramwit, Ph.D
Phone
+66899217255
Email
aramwit@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pornanong Aramwit, Ph.D
Organizational Affiliation
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chulalongkorn Hospital
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pornanong Aramwit, Ph.D.
Phone
+66-89-9217255
Email
aramwit@gmail.com
First Name & Middle Initial & Last Name & Degree
Pornanong Aramwit, Ph.D.

12. IPD Sharing Statement

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Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment

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