Efficacy and Safety of Silk Fibroin With Bioactive Coating Layer Dressing

NCT02091076 | Completed Phase 1 DMC

• 1 other identifier: Chula-53-1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

A split-thickness skin graft (STSG) is used for a large wounds or wounds that cannot be closed by primary and secondary wound closure. Accelerated re-epithelialization rate and minimizing pain and infection are main goals of donor care. Traditionally dressings are inexpensive but adhere to the wound surface and cannot absorb exudates. Thus, we have developed a new biomaterial based on Thai silk for wound dressing application. Silk fibroin and silk sericin were selected to produce wound dressing in this study. The objective of this study is to compare wound dressing containing silk fibroin with bioactive coating layer with standard dressing (medicated paraffin gauze dressing; Bactigras®), with regard to healing time, patients' pain intensity, skin's transepidermal water loss after healing and evidence of infection in the treatment of split-thickness skin graft donor sites. The study design is a randomized, controlled, self paired clinical trial. Patients age 18 to 60 years and undergo STSG at thigh in Department of Surgery, King Chulalongkorn Memorial Hospital will be recruited in the study. The exclusion criteria are donor sites other than thigh area or located at high risk of infection. Patients who are immunocompromised or diabetes mellitus or psychiatric disorders or low serum albumin level (less than 3.0 g/dL) or known allergic to SS or SF or paraffin or chlorhexidine acetate are also excluded. All subjects sign the informed consents after discussion the protocol, benefits and risks. The donor site will be divided into two equal halves, each site will be randomized to receive the tested material or the medicated paraffin gauze dressing. The donor site wounds will be observed daily. The dressings will not be changed, except when they are fully soaked with exudates and easily fell off or any sign of infection. Healing time will be recorded when the dressing separate completely from the donor site, no exudates and no pain when the donor site is exposed to air. The patient's pain level will be evaluated with the visual analogue scale and the donor site wounds will be observed daily for signs of infection. On the day of the wound is recorded for healing time and 1 weeks, 1, 2, 3, 4 and 5 months after that, the skin barrier function (TEWL) of each site will be measured using a Tewameter. Blood sample will be collected from patients pre- and postoperatively (within day 3) for hepatic and renal function analysis.

Conditions

Late Complication From Skin Graft; Infection of Skin Donor Site; Impaired Wound Healing; Pain, Intractable

Keywords

Silk fibroin with bioactive coating layer dressing; Wound healing; Skin graft donor

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy of of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites

  Time for complete epithalization is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. The wounds completely close and without fluid leakage and are able to exposed to the environment without pain. This duration should not exceed than 14 days.

  Within 14 days after operation

Secondary Outcomes (1)

• Clinical safety of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites

  Within 14 days after operation

Other Outcomes (3)

• Clinical safety of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites

  Within 14 days after operation

• Clinical safety of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites

  Within 14 days after operation

• Clinical safety of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites

  Within 14 days after operation

Study Arms (2)

Silk with bioactive coated dressing

EXPERIMENTAL

Silk fibroin coated with bioactive layer, apply once only

Device: Silk fibroin with bioactive coating layer dressing

Control

ACTIVE COMPARATOR

Bactigras wound dressing, apply once only

Device: Bactigras wound dressing

Interventions

Silk fibroin with bioactive coating layer dressing DEVICE

Silk with bioactive coated dressing

Bactigras wound dressing DEVICE

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients age 18 to 60 years.
• Patients have to undergo a split thickness skin graft.
• The donor sites of split-thickness skin graft locate on the thigh.
• Patients consent to participate in this study.

You may not qualify if:

• Donor sites are anywhere else than the thigh area.
• Patients are allergic to silk sericin or silk fibroin or paraffin or chlorhexidine acetate.
• There is a risk of transferring an infection from a nearby infected area to donor site such as acute burn patients.
• Immunocompromised patients such as with acquired immunodeficiency syndrome (AIDS) and renal failure.
• Patients with diabetes mellitus.
• Patients with low serum albumin level (less than 3.0 g/dL)
• Patients have psychiatric disorders or patients with physical disabilities that hinders collaboration.
• Patients who do not comply with the study protocol.
• Pregnancy or lactation

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn Hospital

Bangkok, Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Pain, Intractable

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 19, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: November 3, 2016

Record last verified: 2016-11

Locations

TH (1)