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

Chulalongkorn University30 enrolled

Overview

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.

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®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Wound Heal Wound Surgical Donor Site Complication

Interventions

wound dressing applicationOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chulalongkorn Hospital

Bangkok, Thailand

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 42 days

Secondary Outcomes

Pain score

Pain score evaluated by patient using visual analog scales (0-10)

Time frame: 42 days

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.

Time frame: 42 days

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".

Time frame: 42 days

Vancouver scar scale (VSS)

Vancouver scar scale evaluated by clinician at 1, 3, and 6 months after complete wound healing

Time frame: 6 months

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

Time frame: 6 months

Erythema level

Erythema level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing

Central Contacts

Pornanong Aramwit, Ph.D

CONTACT

+66899217255 aramwit@gmail.com

Data from ClinicalTrials.gov

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