Superficial Partial Thickness Burns Clinical Trial
Official title:
A Randomized Controlled Clinical Trial Comparing The Efficacy and Safety of Open Dressing With Petrolatum Jelly vs. Standard Gauze Dressing With Silver Sulfadiazine in the Treatment of Filipino Adults Aged 18-45 Years Old With Superficial Partial Thickness Burns Less Than or Equal to 10% Total Surface Area Who Are Seen at the Philippine General Hospital Burn Outpatient Clinic
| Verified date | April 2014 |
| Source | University of the Philippines |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Philippines: Philippine General Hospital |
| Study type | Interventional |
The Effectiveness of open dressing with petrolatum jelly in minor burns has not been clearly
established. This study determined if the use of open dressings with petrolatum jelly as
effective as standard gauze dressing with silver sulfadiazine in treating minor burns in
terms of time-to-re-epithelialization, incidence of wound infection,incidence of adverse
reactions, and patient acceptance.
Non-extensive superficial partial thickness burns constitute a major proportion of burn
injuries. Conventional treatment involves regular changing of absorptive dressings including
the application of a topical antimicrobial, commonly silver sulfadiazine. A systematic
review has found insufficient evidence to support or refute such antimicrobial prophylaxis.
Another review compared silver sulfadiazine dressings with other occlusive and
non-antimicrobial dressings and found insufficient evidence to guide practice. Other
research has suggested that dressings with petrolatum gel are as effective as silver
sulfadiazine. This trial sought to compare the effectiveness of conventional silver
sulfadiazine dressings with treatment with petrolatum gel alone.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | July 2010 |
| Est. primary completion date | July 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 45 Years |
| Eligibility |
Inclusion Criteria: - Patients aged 18-45 years old - Superficial partial thickness burns less than or equal to 10% Total Body Surface Area Exclusion Criteria: - Patients with burns involving the primary areas (face, hand, groin, joints, feet) - Previous treatment of the burn wound - Previous burn injury to the same area, electrical burn, and patients with inhalation injury - Patients with diabetes, known sensitivity or allergy to one of the dressings or their constituents and allergy to NSAIDS - Those being treated with systematic steroid medication - Patients with AIDS and AIDS related complex |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Philippines | Philippine General Hospital - University of the Philippines Manila | Manila | National Capital Region |
| Lead Sponsor | Collaborator |
|---|---|
| University of the Philippines | Committee on Research Implementation and Development |
Philippines,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of days to complete re-epithelialization | Time to full re-epithelialization. Wound assessment was conducted daily by the principal investigator, who was blinded to treatment allocation, after the dressings of the study participant were completely removed, including residual cream or petrolatum gel. Time to full re-epithelialization was measured in number of days starting from the day of burn injury. | Participants will be followed up until full re-epithelialization of the wound was noted Time to full re-epithelialization was measured in number of days starting from the day of burn injury. An expected average of up to 2 weeks | Yes |
| Primary | Incidence of wound infection | Wounds were inspected for occurrence of clinical signs of infection, including excessive erythema, edema, pain, purulence, and lymphadenitis (tissue biopsies for microbiologic evaluation were planned in the event of clinical signs of infection) until full re-epithelialization. | An expected average of up to 2 weeks | Yes |
| Primary | Incidence of adverse reactions including allergic contact dermatitis (ACD) | Wounds were inspected for occurrence of ACD (defined as extensive pruritus and a positive patch test) until full re-epithelialization. | An expected average of up to 2 weeks | Yes |
| Secondary | Dressing adherence (score) | Adherence was scored using the following scale. Adherence of dressing to the wound bed: 1 = "none" (no adherence); 2 = "minimal" (adherence to <25% of wound bed); 3 = "moderate" (adherence to 26-75% of the wound bed; 4 = "firm" (adherence to >75% of wound bed). | An expected average of up to 2 weeks | Yes |
| Secondary | Ease of dressing removal (score) | Ease of removal of dressings was scored using the following scale. Ease of removal of dressing: 1 = "easy"; 2 = "moderate"; 3 = "difficult". | An expected average of up to 2 weeks | Yes |
| Secondary | Time taken to change dressing (score) | Time taken to change dressing was categorized as: 1 = 1-5 minutes; 2 = 6-10 minutes; 3 = 11-15 minutes; 4 = 16-20 minutes; 5 = 21-25 minutes; 6 = 26-30 minutes. | An expected average of up to 2 weeks | Yes |
| Secondary | Number of dressing changes and reapplications during the day (score) | The reported number of dressing changes within the day from last assessment were categorized as: 1 = 0-2 times; 2 = 3-4 times; 3 = > 4 times. | An expected average of up to 2 weeks | Yes |
| Secondary | Pain during dressing changes (score) | Participant-reported pain during removal of dressing was evaluated using a visual analogue scale (VAS) of 0-10. | An expected average of up to 2 weeks | Yes |
| Secondary | Pain during removal of dressings (score) | Participant-reported pain while dressing the wound was evaluated using a visual analogue scale (VAS) of 0-10. | An expected average of up to 2 weeks | Yes |