Superficial Partial Thickness BurnsPhase 3NCT02109718
A Trial Comparing the Efficacy and Safety of Open Dressing With Petrolatum Jelly vs. Standard Gauze Dressing With Silver Sulfadiazine
A Phase 3 study testing Open Dressings with Petrolatum Jelly and Silver Sulfadiazine Gauze Dressing Group in people with Superficial Partial Thickness Burns, run by University of the Philippines at 1 site in Philippines.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Superficial Partial Thickness Burns
- What is being tested?
- Open Dressings with Petrolatum Jelly and Silver Sulfadiazine Gauze Dressing Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePhilippines
- Study dates
- Jan 2009to Jul 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-45 years old
- Superficial partial thickness burns less than or equal to 10% Total Body Surface Area
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Philippines1 site
Philippine General Hospital - University of the Philippines Manila
Manila, National Capital Region, 1000
About this study
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.
Read the 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.
- Conditions
- Superficial Partial Thickness Burns
- Being tested
- Open Dressings with Petrolatum Jelly, Silver Sulfadiazine Gauze Dressing Group
- Keywords
- Burns, Dressings, Outpatient Management, Petrolatum Jelly, Superficial Partial Thickness Burns, Less than or equal to 10% Total Body Surface Area
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Dressings with Petrolatum JellyDrug
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.
Silver Sulfadiazine Gauze Dressing GroupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Open Dressings with Petrolatum Jelly | Experimental | participants randomized to this arm had their wounds dressed with Open Dressing with Petrolatum Jelly Receives: Drug: Open Dressings with Petrolatum Jelly |
| Silver Sulfadiazine Gauze Dressing Group | Active comparator | Participants randomized to this arm had their wounds dressed with Silver Sulfadiazine Gauze Dressing. Receives: Drug: Silver Sulfadiazine Gauze Dressing Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: An expected average of up to 2 weeks
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.
Measured: An expected average of up to 2 weeks
Secondary outcomes (6)
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).
Measured: An expected average of up to 2 weeks
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".
Measured: An expected average of up to 2 weeks
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.
Measured: An expected average of up to 2 weeks
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.
Measured: An expected average of up to 2 weeks
Pain during dressing changes (score)
Participant-reported pain during removal of dressing was evaluated using a visual analogue scale (VAS) of 0-10.
Measured: An expected average of up to 2 weeks
Pain during removal of dressings (score)
Participant-reported pain while dressing the wound was evaluated using a visual analogue scale (VAS) of 0-10.
Measured: An expected average of up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startJan 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Superficial Partial Thickness BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Collaborators
- Committee on Research Implementation and Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109718
- Sponsor's protocol ID
- SUR-2009-06-11-033
- Status last verified
- Apr 2014
- First submitted
- 20 Mar 2014
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25172229
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02109718
- Acronym / sponsor ID
- SUR-2009-06-11-033
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Collaborators
- Committee on Research Implementation and Development
- Study start
- Jan 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Dressings with Petrolatum Jelly | Experimental | Drug: Open Dressings with Petrolatum Jellyparticipants randomized to this arm had their wounds dressed with Open Dressing with Petrolatum Jelly |
| Silver Sulfadiazine Gauze Dressing Group | Active comparator | Drug: Silver Sulfadiazine Gauze Dressing GroupParticipants randomized to this arm had their wounds dressed with Silver Sulfadiazine Gauze Dressing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aged 18-45 years old
- Superficial partial thickness burns less than or equal to 10% Total Body Surface Area
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Dressings with Petrolatum Jellyparticipants 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. | Drug | Open Dressings with Petrolatum Jelly |
| Silver Sulfadiazine Gauze Dressing GroupParticipants 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. | Drug | Silver Sulfadiazine Gauze Dressing Group |
Primary outcome
Number of days to complete re-epithelialization
Time frame: 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
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.
Incidence of wound infection
Time frame: An expected average of up to 2 weeks
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.
Incidence of adverse reactions including allergic contact dermatitis (ACD)
Time frame: An expected average of up to 2 weeks
Wounds were inspected for occurrence of ACD (defined as extensive pruritus and a positive patch test) until full re-epithelialization.
6 secondary outcomes
Dressing adherence (score)
Time frame: An expected average of up to 2 weeks
Ease of dressing removal (score)
Time frame: An expected average of up to 2 weeks
Time taken to change dressing (score)
Time frame: An expected average of up to 2 weeks
Number of dressing changes and reapplications during the day (score)
Time frame: An expected average of up to 2 weeks
Pain during dressing changes (score)
Time frame: An expected average of up to 2 weeks
Pain during removal of dressings (score)
Time frame: An expected average of up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
- Derived from this study: PubMed 25172229Genuino 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Open Dressings with Petrolatum Jelly and Silver Sulfadiazine Gauze Dressing Group in people with Superficial Partial Thickness Burns, run by University of the Philippines at 1 site in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days to complete re-epithelialization (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02109718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2014.