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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04743375
Other study ID # Med Chula IRB 143/63
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 2021
Est. completion date December 2021

Study information

Verified date February 2021
Source Chulalongkorn University
Contact Pornanong Aramwit, Ph.D
Phone +66899217255
Email aramwit@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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®.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2021
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
wound dressing application
Sericin dressing with collagen or Bactigras will be used as a primary dressing for treating the STSG donor site.

Locations

Country Name City State
Thailand Chulalongkorn Hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 42 days
Secondary Pain score Pain score evaluated by patient using visual analog scales (0-10) 42 days
Secondary 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. 42 days
Secondary 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". 42 days
Secondary Vancouver scar scale (VSS) Vancouver scar scale evaluated by clinician at 1, 3, and 6 months after complete wound healing 6 months
Secondary 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 6 months
Secondary Erythema level Erythema level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing 6 months
Secondary Melanin level Melanin level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing 6 months
Secondary Trans-epidermal water loss (TEWL) TEWL measured by using Tewameter® at 1, 3, and 6 months after complete wound healing 6 months
Secondary Skin hydration Hydration level measured by using Corneometer® at 1, 3, and 6 months after complete wound healing 6 months
Secondary Skin elasticity Elasticity parameters measured by using Cutometer® at 1, 3, and 6 months after complete wound healing 6 months
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