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
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment