Clinical trial NCT02109718: A Trial Comparing the Efficacy and Safety of Open Dressing With Petrolatum Jelly vs. Standard Gauze Dressing With Silver Sulfadiazine
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Superficial Partial Thickness Burns
Keywords: Burns
Dressings
Outpatient Management
Petrolatum Jelly
Superficial Partial Thickness Burns
Less than or equal to 10% Total Body Surface Area
Lead sponsor: University of the Philippines
Sponsor class: OTHER
Collaborators: name: Committee on Research Implementation and Development
First posted: 2014-04-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Patients with superficial partial thickness burns less than 10% Total Body Surface Area were recruited. 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 burns, and patients with inhalation injury were excluded Also excluded were patients with diabetes, known sensitivity or allergy to one of the dressings or their constituents and allergy to NSAIDS, those being treated with systemic steroid medication, and patients with AIDS and AIDS related complex. Participants were then randomized to undergo either open dressings with petrolatum jelly or standard gauze dressings with silver sulfadiazine cream. The number of days to complete re-epithelialization was recorded for each patient. The incidence of wound infection and adverse reactions, notably the occurrence of allergic contact dermatitis was also recorded. The study also assessed both dressings in terms of adherence to the wound bed, ease of dressing removal, pain on application and removal of dressings, time required for dressing change and number of dressing changes in between follow-ups..

A total of 50 participants were recruited. Age, sex, race, health condition, location of burn, % Total Body Surface Area area affected, time lag, causative agent, presence of initial cooling maneuver, medical condition, and associated injuries were similar for petrolatum jelly and silver sulfadiazine groups. There was no significant difference with regard to number of days to re-epithelialization. There was also no significant difference between the two treatment groups with regards to pain experienced during application and removal of the dressings, and the number of dressing changes required in between follow-ups. There was, however, a significant difference between open dressings with petrolatum jelly and silver sulfadiazine gauze dressing in terms of adherence to the wound bed, ease of removal of dressings and time required to change dressings. Open dressings with petrolatum jelly were found to be less adherent, easier to remove, and required less time for dressing change.

Single-center, randomized, controlled clinical trial. Consenting adults 18-45 years old with superficial partial thickness burns less than or equal to 10% total body surface area seen within 24 hours of the injury were randomized to daily dressing either with petrolatum gel without top dressings or conventional silver sulfadiazine treatment with gauze dressings. Primary outcomes were blinded assessment of time to complete re-epithelialization, wound infection or allergic contact dermatitis. Secondary outcomes included assessment of ease, time and pain of dressing changes.

50 patients were recruited and follow up data available for 38. Mean time to re-epithelialization was shorter in the treatment group by more than one day within an overall mean healing time of 7.0 days (p = 0.050). No wound infection or dermatitis was observed in either group. Scores for adherence to the wound, ease of dressing removal and time required to change dressings were significantly better in the petrolatum treatment arm (p \< 0.01).

Petrolatum gel without top dressings may be at least as effective as silver sulfadiazine gauze dressings with regard to time to re-epithelialization, and incidence of infection and allergic contact dermatitis. Petrolatum gel appears to be an effective, affordable and widely available alternative in the treatment of minor superficial partial thickness burns in adults.

Eligibility criteria: 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

Primary outcomes:
measure: Number of days to complete re-epithelialization
timeFrame: 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
measure: Incidence of wound infection
timeFrame: An expected average of up to 2 weeks
measure: Incidence of adverse reactions including allergic contact dermatitis (ACD)
timeFrame: An expected average of up to 2 weeks
Secondary outcomes:
measure: Dressing adherence (score)
timeFrame: An expected average of up to 2 weeks
measure: Ease of dressing removal (score)
timeFrame: An expected average of up to 2 weeks
measure: Time taken to change dressing (score)
timeFrame: An expected average of up to 2 weeks
measure: Number of dressing changes and reapplications during the day (score)
timeFrame: An expected average of up to 2 weeks
measure: Pain during dressing changes (score)
timeFrame: An expected average of up to 2 weeks
measure: Pain during removal of dressings (score)
timeFrame: An expected average of up to 2 weeks
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Philippine General Hospital - University of the Philippines Manila
state: National Capital Region
Study officials:
References:
citation: Genuino GA, Baluyut-Angeles KV, Espiritu AP, Lapitan MC, Buckley BS. Topical petrolatum gel alone versus topical silver sulfadiazine with standard gauze dressings for the treatment of superficial partial thickness burns in adults: a randomized controlled trial. Burns. 2014 Nov;40(7):1267-73. doi: 10.1016/j.burns.2014.07.024. Epub 2014 Aug 27.