Plain English Summary
Background and study aims
Second-degree burns affect the epidermis and the dermis (lower layer of the skin). They cause pain, redness, swelling, and blistering. Sericin is a protein created by silkworms in the production of silk, which has been found to promote wound healing. The aim of this study is to assess the effectiveness of a silver zinc sulfadiazine (antibiotic) cream with added sericin for the treatment of patients with second-degree burn wounds.
Who can participate?
Patients aged 15-60 with second-degree burn wounds
What does the study involve?
Participants undergo an initial assessment including demographic information, medical and social history, and an assessment of the burn injury with photographs. On the day of admission, body temperature recordings and blood samples are taken from all participants to determine the possibility of infection, as well as liver and kidney function. Body temperature recordings and blood tests are repeated on days 7, 14 and 28 after admission. The extent of the burn injuries is determined. Participants are then randomly allocated to be treated with either silver zinc sulfadiazine cream or silver zinc sulfadiazine cream containing sericin. All participants are treated with fluid replacement with daily dressing changes and topical cream treatment during their period of hospitalization. After admission, the wounds are cleaned with normal saline (salt) solution and the cream is directly applied to the wound. The dressing is changed and the cream is applied once daily. Treatment is continued until the wounds are completely healed. A wound swab is taken after 2 weeks. The wound is checked at each dressing change for signs of infection and healing by expert surgeons. The length of time to heal is also recorded and side effects, if any, are assessed. Pain is assessed in all participants every 7 days 30 minutes after a dressing change. Burn health status is also evaluated.
What are the possible benefits and risks of participating?
Participants may benefit from faster wound healing and better quality of life but may experience side effects from silk sericin.
Where is the study run from?
Mahidol University (Thailand)
When is the study starting and how long is it expected to run for?
September 2010 to August 2011
Who is funding the study?
National Research Council (Thailand)
Who is the main contact?
Associate Professor Pornanong Aramwit
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
03/55
Study information
Scientific title
Efficacy of silver zinc sulfadiazine cream containing silk sericin for the treatment of burn wounds: a randomized controlled trial
Acronym
Study hypothesis
1. Silver zinc sulfadiazine cream containing silk sericin is more efficient than silver zinc sulfadiazine cream alone in patients with second degree burn wounds.
2. Silver zinc sulfadiazine cream containing silk sericin is safe for the treatment of second degree burn wounds.
Ethics approval
Institutional Review Board Committee, Mahidol University, 23/09/2010, ref: 301/2553 (EC1)
Study design
Randomized double-blind placebo-controlled experimental study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Second degree burn wounds
Intervention
After eligibility was established, an initial evaluation was performed on each patient that included recording subject demographics, medical and social history, and a baseline assessment of the burn injury with photographic documentation. On the day of admission, body temperature and blood samples were taken from all patients to determine the possibility of infection, as well as liver and renal functions, blood glucose, electrolytes, blood counts, albumin level, and blood gases. Body temperature recording and the same blood examinations were repeated on days 7, 14 and 28 after admission. Total body surface area standard formulae were provided and used to determine the extent of the burn injuries.
Patients were then randomly assigned to a care protocol that included either silver zinc sulfadiazine cream (control) or silver zinc sulfadiazine cream containing sericin (treatment); the physician investigators and other medical personnel were blinded to the type of treatment from the first day of admission until the wounds were completely healed. All patients were treated with fluid resuscitation and fluid replacement according to the Parkland formula, with daily dressing changes and topical cream treatment during their period of hospitalization. After admission, the wounds were cleaned with normal saline solution and the topical agent (either silver zinc sulfadiazine cream or silver zinc sulfadiazine cream containing sericin) was directly applied to the wound. The dressing was changed and the creams applied once daily. Treatment with the topical agents was continued until the wounds were completely healed and epithelialized. A wound swab culture was taken after 2 weeks. The wound was clinically observed at each dressing change for signs of infection and the size as well as the nature of epithelialization by expert surgeons. The wound size was measured using Visitrak Digital and the healing percentage of the wound was calculated. The length of time to heal was also recorded and adverse drug reactions, if any, were assessed using Naranjos algorithm.
Pain was assessed in all patients every 7 days using the visual analog scale 30 min after a dressing change. Burn health status was also evaluated using Burn-Specific Health Scale-Brief (BSHS-B) with slight modifications.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The wound size was measured using Visitrak Digital and the healing percentage of the wound was calculated. The length of time to heal was also recorded.
Secondary outcome measures
1. Adverse drug reactions were assessed using Naranjos algorithm
2. Pain was assessed in all patients every 7 days using the visual analog scale 30 min after a dressing change
3. Burn health status was also evaluated using Burn-Specific Health Scale-Brief (BSHS-B)
Overall trial start date
01/09/2010
Overall trial end date
30/08/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 15-60 years of age
2. Second degree burn wounds covering no less than 15% of the total body surface area (TBSA) with no wound infection
3. Patients were to stay at the hospital until the wounds were completely healed
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
16 patients
Participant exclusion criteria
1. Patients with history of allergy to sulfonamides, sericin, or any of the other ingredients in the formulation
2. Patients who had active diabetes mellitus, chronic obstructive pulmonary disease, psychological problems, dementia, malnutrition or immunodeficiency
3. Patients who experienced abnormal liver or renal function tests prior to enrollment
4. Patients with cancer or receiving chemotherapy and those who were pregnant or breastfeeding
5. Patients who show no response to the treatment, were not willing to continue with the study, or when the physician opined that treatment was no longer needed
Recruitment start date
01/09/2010
Recruitment end date
30/08/2011
Locations
Countries of recruitment
Thailand
Trial participating centre
Chulalongkorn University
Bangkok
10330
Thailand
Sponsor information
Organisation
National Research Council (Thailand)
Sponsor details
196 Paholyotin Road
Chatuchak
Bangkok
10900
Thailand
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
National Research Council (Thailand) ref: 2554-21
Alternative name(s)
CNR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Italy
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list