Donor Site Complication, Wound Heal, Wound Surgical
Conditions
Keywords
Wound dressing, Sericin, Collagen, Split-thickness skin graft donor site (STSG donor site)
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®.
Interventions
OTHERwound dressing application
Sericin dressing with collagen or Bactigras will be used as a primary dressing for treating the STSG donor site.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to complete healing | 42 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of infection | 42 days | 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 | 42 days | 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) | 6 months | 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) | 6 months | Patient scale of Patient and observer scar scale (POSAS) evaluated by patients 6 months after complete wound healing |
| Pain score | 42 days | Pain score evaluated by patient using visual analog scales (0-10) |
| Melanin level | 6 months | Melanin level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing |
| Trans-epidermal water loss (TEWL) | 6 months | TEWL measured by using Tewameter® at 1, 3, and 6 months after complete wound healing |
| Skin hydration | 6 months | Hydration level measured by using Corneometer® at 1, 3, and 6 months after complete wound healing |
| Skin elasticity | 6 months | Elasticity parameters measured by using Cutometer® at 1, 3, and 6 months after complete wound healing |
| Erythema level | 6 months | Erythema level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing |
Countries
Thailand
Contacts
Primary ContactPornanong Aramwit, Ph.D
Outcome results
None listed