A Trial Comparing the Efficacy and Safety of Open Dressing With Petrolatum Jelly vs. Standard Gauze Dressing With Silver Sulfadiazine
Condition: Superficial Partial Thickness Burns
MeSH terms: Burns
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Open Dressings with Petrolatum Jelly; Silver Sulfadiazine Gauze Dressing Group
Intervention type(s): Drug; Drug
Intervention description(s): participants randomized to this arm had their wounds dressed with a thin layer (1mm) of petrolatum gel applied over the burn wound and instructed to reapply the gel as needed in the event of gel coming off.; Participants randomized to this arm had their wounds dressed using the standard methods at the Burn Center. An initial layer of fine mesh gauze is applied that is laden with a 2mm layer of silver sulfadiazine cream. This is covered with layers of moist gauze and an outer layer of dry gauze, secured by wrapping with rolled gauze. The dressing extends at least 1 inch beyond the wound edge.
Intervention MeSH terms: Sulfadiazine; Silver Sulfadiazine; Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Burns; Dressings; Outpatient Management; Petrolatum Jelly; Superficial Partial Thickness Burns; Less than or equal to 10% Total Body Surface Area