Effect of EGF With Silver Sulfadiazine Cream Compared With Silver Zinc Sulfadiazine Cream for Treatment of Burn Wound

NCT01553708 | Completed Phase 2 Results DMC

• 1 other identifier: CU0155
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Partial thickness burn wounds are most likely to heal within 2-3 weeks mainly by mechanism of epithelialization. However, it depends on the depth of the wounds and patient condition. Infection is one of the most common complications causing delay in wound healing which might affect to quality of patient's life. Generally, the standard treatment of partial thickness burn wound is topical 1% silver sulfadiazine cream. Previous studies had been reported the broad spectrum antimicrobial activity of silver sulfadiazine cream but it did not demonstrate the accelerating effect of wound healing. Therefore, the combination of substance which can promote wound healing to topical silver sulfadiazine cream might benefit for partial thickness burn wound treatment. The objective of this study was to compare the results of partial thickness burn wound treatment at burn unit, Siriraj hospital with topical cream containing 1% silver sulfadiazine plus 6% epidermal growth factor (EGF) and 1% silver zinc sulfadiazine. The demographic data (age, sex, %body surface area burn), time of wound closure, pain and itching, dose and type of pain and itching medication, adverse effect of topical medication, some laboratory results and cost of expenses. This is the prospective, double blinded, randomize-controlled study. The sample sizes were partial thickness burn wound patients who were treated at burn unit, Siriraj hospital. Patients were allocated into 2 groups receiving treatment with either topical silver sulfadiazine plus EGF or silver zinc sulfadiazine. All parameter data were analyzed with repeated measure ANOVA and independent t-test.

Conditions

Deep Partial Thickness Burn

Keywords

Wound healing; Epithelialization; Safety

Outcome Measures

Primary Outcomes (1)

• Time of Healing by Monitoring Duration (Days) at the Beginning of Treatment and the Day of Completely Epithelialization (Complete Epithelialization Means no Open Wound Exists as Confirmed by Two Surgeons).

  Time (days)for complete epithelialization (no open wound exists as determined by 2 surgeons) is the duration between the day of admission and the wound completely close without fluid leakage and are able to expose to environment without pain.

  On 28th day after admission

Secondary Outcomes (1)

• Clinical Safety of Epidermal Growth Factor With Silver Sulfadiazine Cream for Treatment of Partial Thickness Burn Wound.

  On 28th day after admission

Study Arms (2)

Epidermal growth factor with silver sulfadiazine cream

EXPERIMENTAL

Epidermal growth factor with silver sulfadiazine cream was applied to the experimental wounds completely and then covered with sterile gauze. The wound was cleaned every 24 h and the cream was then applied again after cleaning process.

Drug: Epidermal growth factor with silver sulfadiazine cream

Silver zinc sulfadiazine cream

ACTIVE COMPARATOR

Silver sulfadiazine cream was applied to cover the controlled-wound completely and then covered with sterile gauze. The wound was cleaned every 24 h and the cream was then applied again after cleaning process.

Drug: Silver zinc sulfadiazine cream

Interventions

Epidermal growth factor with silver sulfadiazine cream DRUG

Compare the duration for complete partial thickness burn wound healing between sample (epidermal growth factor with silver sulfadiazine cream) and control (silver zinc sulfadiazine cream)

Epidermal growth factor with silver sulfadiazine cream

Silver zinc sulfadiazine cream DRUG

Compare the duration for complete partial thickness burn wound healing between sample (epidermal growth factor with silver sulfadiazine cream) and control (silver zinc sulfadiazine cream)

Silver zinc sulfadiazine cream

Eligibility Criteria

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

You may qualify if:

• Aged 18-60 years.
• Partial thickness burn wound more than 20%TBSA.
• No underlying diseases that interfere wound healing such as chronic kidney disease, diabetes mellitus, liver disease, immunocompromised deficiency.
• In case of reproductive age woman, they have to control the birth rate at least 4 weeks before study.
• Patients who are willing to participate in the trial and to sign the informed consent form.

You may not qualify if:

• Immunocompromised defects
• Known allergy or hypersensitivity reaction to epidermal growth factor, silver sulfadiazine or other substances in formulation.
• Pregnancy or lactation

Sponsors & Collaborators

• Chulalongkorn University: lead
• National Science and Technology Development Agency, Thailand: collaborator

Study Sites (1)

Burn Unit, Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Interventions

Epidermal Growth Factor

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; EGF Family of Proteins; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed and all samples have 18-60 years of age, this data cannot be applied for pediatrics.

Results Point of Contact

• Title: Associate Prof. Pornanong Aramwit, Pharm.D., Ph.D.
• Organization: Faculty of Pharmaceutical Sciences, Chulalongkorn University

paramwit@gmail.com

+66-02-218-8409

Study Officials

• Pornanong Aramwit, Pharm.D., Ph.D.

  Faculty of Pharmaceutical Sciences, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 28, 2012
• First Posted: March 14, 2012
• Study Start: December 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 25, 2013
• Results First Posted: August 9, 2012

Record last verified: 2013-03

Locations

TH (1)