MedTrace Logo

Efficacy and Safety of Silk Fibroin With Bioactive Coating Layer Dressing

NCT02091076 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2016-11-03

No results posted yet for this study

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

Interventions

DEVICE

Silk fibroin with bioactive coating layer dressing

DEVICE

Bactigras wound dressing

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02091076 on ClinicalTrials.gov