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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01539980

Late Complication From Skin Graft Infection of Skin Donor Site Impaired Wound Healing +1 more

COMPLETED PHASE1/PHASE2

Clinical Study of Biocellulose Wound Dressing Containing Silk Sericin and PHMB for STSG Donor Sites

NCT02643680

Wound Disorder of Skin Donor Site

UNKNOWN PHASE2

Efficacy and Safety of Silk Fibroin With Bioactive Coating Layer Dressing

NCT02091076

Late Complication From Skin Graft Infection of Skin Donor Site Impaired Wound Healing +1 more

COMPLETED PHASE1/PHASE2

Efficacy and Safety of High Absorption Pad in Split-thickness Skin Graft Donor Site Wound

NCT04299126

Disorder of Skin Donor Site

UNKNOWN NA

Clinical Efficacy and Safety of Sericin Hydrogel Sheet Impregnated With Bird's Nest Extract

NCT04997863

Wound Donor Site Complication Skin Graft Scar +1 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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®.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wound Heal Wound Surgical Donor Site Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sericin dressing with collagen

Group Type EXPERIMENTAL

wound dressing application

Intervention Type OTHER

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

Bactigras

Commercial dressing

Group Type ACTIVE_COMPARATOR

wound dressing application

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

wound dressing application

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No