BurnsMSBINCT02250183
Medihoney and Santyl for Burn Injuries
A study testing MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY and Santyl in people with Burns, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
Trial summary
This study is designed to assess the efficacy of MEDIHONEY® Gel with Active leptospermum honey dressing relative to SANTYL® ointment dressing on time to heal, bacterial growth in the wound, patient satisfaction, and treatment costs in patients with partial thickness burns. The study has four hypotheses: 1. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns
- What is being tested?
- MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY and Santyl
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2014to 18 Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- New patient presenting with a partial thickness burn injury in at least two non-contiguous locations of the body.
- Enrollment will occur within 72 hours of sustaining a burn injury.
Who cannot join
- Cognitive or language barriers that preclude completion of study measures.
- Have burn injuries exceeding 40% total body surface area (TBSA).
- Have a diagnosis of immunodeficiency or kidney disease.
- Are receiving treatment (e.g., chemotherapy, dialysis) that can create concerns with immunodeficiency or affect healing.
- Are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Pennsylvania Hospital Burn Center
Pittsburgh, Pennsylvania, 15224
About this study
Official title: A Comparison of Medihoney® Gel With Active Leptospermum Honey and Santyl® in the Treatment of Partial Thickness Burns
This study is designed to assess the efficacy of MEDIHONEY® Gel with Active leptospermum honey dressing relative to SANTYL® ointment dressing on time to heal, bacterial growth in the wound, patient satisfaction, and treatment costs in patients with partial thickness burns. The study has four hypotheses:
- It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey will result in significantly faster wound healing (i.e., fewer days) when compared to SANTYL®.
- It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey sites will yield significantly fewer positive cultures for Pseudomonas aeruginosa and other bacteria when compared to SANTYL® sites.
- It is hypothesized that patients will provide significantly higher patient care satisfaction ratings regarding their MEDIHONEY® Gel with Active leptospermum honey sites when compared to ratings with regard to their SANTYL® sites.
- It is hypothesized that treatment costs, across participants, will be significantly lower for MEDIHONEY® Gel with Active leptospermum honey than for SANTYL®.
Read the detailed description
Researchers have examined the usefulness of honey as a treatment for a variety of wounds. Molan outlines some of the benefits of honey in the treatment of wounds, such as its effective antibacterial activity, debriding action, anti-inflammatory component, and antioxidant activity. In addition, the acidity of honey may improve wound healing by decreasing the pH of the wound and providing more oxygen, which ultimately helps to regenerate tissue .
Many studies have demonstrated the effectiveness of honey's antibacterial properties. For example, the antibacterial activity of honey has been shown to protect against multi-resistant strains of bacteria including multi-resistant staphylococcus aureus (MRSA) and Pseudomonas aeruginosa. In fact, research suggests that honey may be an effective antibacterial agent for bacteria that were resistant to up to 13 different antibiotics. Related specifically to burn injuries, results from another study indicated that honey may be an effective antibacterial agent and treatment option for burn injuries infected with or at risk for infection with Pseudomonas aeruginosa. Furthermore, unlike other antibiotics used in clinical care, the possibility of developing honey-resistant wound pathogens is rare, even when using high concentrations of honey, according to one study. Results from these studies provide strong evidence for the usefulness of honey's antibacterial activity in the treatment of wounds, including burn injuries.
In addition to its antibacterial properties, honey has been found to promote wound healing in patients with burn injuries. For example, one study compared the effectiveness of a honey dressing to silver sulfadiazene (SSD) on wound healing in 78 child and adult burn patients with first and second degree burns. According to the results from this study, patients treated with honey dressings had a significantly lower average duration of healing (in days) compared to patients treated with SSD. In addition, approximately half of the wounds treated with honey dressings became sterile within seven days while none of the wounds became sterile during this span of time for the patients who were treated with SSD. The authors of this study also reported that 30 of the 37 patients (81%) treated with honey achieved complete recovery (i.e., complete healing two months post-burn injury without scarring or contractures) compared to 15 out of 41 patients (37%) treated with SSD. Another study by Baghel and colleagues using a similar sample found comparable results. In this second study, patients who were treated with honey dressings were found to heal significantly faster, have sterile wounds in less time, and have better overall recoveries (i.e., fewer hypertrophic scars and contractures) when compared to those patients who were treated with SSD.
Another study compared honey and SSD on burn wound healing (i.e., improvement in burn wound size and re-epithelialization) in patients with superficial partial thickness burns. Patients included in this study had similar burns (e.g., second degree burns of similar depth) on comparable burned surface areas (e.g., right hand and left hand). In addition, patients in this study received both treatment options; that is, a patient's right hand was treated with honey while his/her left hand was treated with SSD. Results from this study indicated that the average healing time was significantly shorter for the body surfaces treated with honey. Interestingly, the wounds treated with honey were found to heal approximately two days faster than the wounds treated with SSD. Additionally, cultures of the wounds found that only six patients tested positive for Pseudomonas aeruginosa in the sites that were treated with honey compared to 27 patients in the sites treated with SSD. Two additional patients tested positive for Escherichia coli infection in the wound sites that were treated with SSD. The authors of this study concluded that honey was a more effective treatment for superficial partial thickness burns than SSD.
Taken together, these studies provide preliminary evidence that honey may be an effective treatment option for partial thickness burns, with benefits such as faster wound healing and wound sterilization. In addition, MEDIHONEY® is cleared by the FDA to maintain a moist environment conducive to wound healing. However, studies have yet to explore the generalizability of these findings to samples of patients with burn injuries in the United States, as all the previously cited studies were conducted outside of the United States. In addition, studies thus far have examined the effectiveness of honey as a wound treatment and have failed to evaluate patient care satisfaction with honey as a treatment option and the treatment costs associated with the use of honey in clinical care. These two outcomes can provide valuable insight into the appropriateness and feasibility of using honey in everyday clinical care. Overall, information obtained from this study will yield knowledge on the potential benefits of this product for burn wound treatment compared to standard care (i.e., SANTYL®).
- Conditions
- Burns
- Being tested
- MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY, Santyl
- Keywords
- Medihoney, Santyl, Burns
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEYDevice
Also called Medihoney
MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY dressing is manufactured by the company Derma Sciences, Inc. and is a moist dressing made of Active Leptospermum Honey (+15) in combination with natural gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing, even in the presence of body heat and fluids. As a percentage of the overall dressing, MEDIHONEY® GEL dressings contains 80% honey. The dressing has a low pH and can help to lower the overall pH of wounds. The dressing also possesses a high osmotic potential, which assists in debridement.
SantylDevice
SANTYL® Ointment is an FDA-approved sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. The enzyme SANTYL® is derived from the fermentation by Clostridium histolyticum. It possesses the unique ability to digest collagen in necrotic tissue. SANTYL® Ointment is indicated for debriding chronic dermal ulcers and severely burned areas.
| Study group | Role | What they receive |
|---|---|---|
| Medihoney & Santyl | Other | Each patient will receive both interventions simultaneously, but on non-contiguous parts of the body that each consist of partial thickness burn injuries of similar depth. For example, if a patient presents with bilateral second-degree burns to the lower extremities, one leg will be treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg will be treated with SANTYL® ointment dressing. MEDIHONEY® is the target treatment for this study, while SANTYL® is standard care. Receives: Device: MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY; Device: Santyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wound Appearance
Pictures of wounds and associated "seepage test" paper towels, without indication of date or arm of treatment, were rated by two independent physicians regarding healed or not yet healed. This information was then be used to calculate a "time to heal" variable (# of days) for each patient.
Measured: Daily for 7 to 21 days, depending on time it takes burn injury to completely heal
Secondary outcomes (1)
Number of Participants With Presence vs. Absence of Bacteria in Burn Wound
Wound swab culture results will be compared between treatment modalities via a McNemar test, with treatment modality (MEDIHONEY® GEL versus SANTYL® ointment) and outcome (Positive versus Negative wound culture results for presence of Pseudomonas aeruginosa and/or other bacteria) as the independent and dependent variables, respectively. Each participant has two wound cultures, one for MEDIHONEY® GEL and one for SANTYL® ointment.
Measured: Day 7 of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study start15 Mar 2014
- Primary completion18 Aug 2016
- Study completion18 Aug 2016
Why it stopped: Recruitment was too slow due to strict inclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Sponsor type
- University, hospital or other
- Collaborators
- Integra LifeSciences Corporation, West Virginia University
- Responsible party
- Principal investigator, Christina Duncan, West Virginia University
- Investigators
- Ariel M Aballay, MD, Principal investigator, Western Pennsylvania Hospital Burn CenterChristina L Duncan, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250183
- Sponsor's protocol ID
- 13-021
- Acronym
- MSBI
- Status last verified
- May 2019
- First submitted
- 15 Sep 2014
- Last updated
- 22 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Molan PC. The evidence and the rationale for the use of honey as a wound dressing. Wound Practice and Research, 19(4): 204-220, 2011.
Blair SE, Cokcetin NN, Harry EJ, Carter DA. The unusual antibacterial activity of medical-grade Leptospermum honey: antibacterial spectrum, resistance and transcriptome analysis. Eur J Clin Microbiol Infect Dis. 2009 Oct;28(10):1199-208. doi: 10.1007/s10096-009-0763-z. Epub 2009 Jun 10.
PubMed 19513768George NM, Cutting KF. Antibacterial Honey (Medihoney): in-vitro Activity Against Clinical Isolates of MRSA, VRE, and Other Multiresistant Gram-negative Organisms Including Pseudomonas aeruginosa. Wounds. 2007 Sep;19(9):231-6.
PubMed 25942744Cooper RA, Halas E, Molan PC. The efficacy of honey in inhibiting strains of Pseudomonas aeruginosa from infected burns. J Burn Care Rehabil. 2002 Nov-Dec;23(6):366-70. doi: 10.1097/00004630-200211000-00002.
PubMed 12432313Cooper RA, Jenkins L, Henriques AF, Duggan RS, Burton NF. Absence of bacterial resistance to medical-grade manuka honey. Eur J Clin Microbiol Infect Dis. 2010 Oct;29(10):1237-41. doi: 10.1007/s10096-010-0992-1. Epub 2010 Jun 13.
PubMed 20549529Gupta SS, Singh O, Bhagel PS, Moses S, Shukla S, Mathur RK. Honey dressing versus silver sulfadiazene dressing for wound healing in burn patients: a retrospective study. J Cutan Aesthet Surg. 2011 Sep;4(3):183-7. doi: 10.4103/0974-2077.91249.
PubMed 22279383Baghel PS, Shukla S, Mathur RK, Randa R. A comparative study to evaluate the effect of honey dressing and silver sulfadiazene dressing on wound healing in burn patients. Indian J Plast Surg. 2009 Jul;42(2):176-81. doi: 10.4103/0970-0358.59276.
PubMed 20368852Malik KI, Malik MA, Aslam A. Honey compared with silver sulphadiazine in the treatment of superficial partial-thickness burns. Int Wound J. 2010 Oct;7(5):413-7. doi: 10.1111/j.1742-481X.2010.00717.x.
PubMed 20649832
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Medihoney® Gel With Active Leptospermum Honey and Santyl® in the Treatment of Partial Thickness Burns
- ClinicalTrials.gov ID
- NCT02250183
- Acronym / sponsor ID
- MSBI / 13-021
- Conditions
- Burns
- Keywords
- Medihoney, Santyl, Burns
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was too slow due to strict inclusion criteria.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)University, hospital or other
- Collaborators
- Integra LifeSciences Corporation, West Virginia University
- Study start
- 15 Mar 2014 (actual)
- Primary completion
- 18 Aug 2016 (actual)
- Study completion
- 18 Aug 2016 (actual)
- First posted
- 26 Sep 2014 (estimated)
- Results
- Posted 2 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the efficacy of MEDIHONEY® Gel with Active leptospermum honey dressing relative to SANTYL® ointment dressing on time to heal, bacterial growth in the wound, patient satisfaction, and treatment costs in patients with partial thickness burns. The study has four hypotheses:
- It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey will result in significantly faster wound healing (i.e., fewer days) when compared to SANTYL®.
- It is hypothesized that MEDIHONEY® Gel with Active leptospermum honey sites will yield significantly fewer positive cultures for Pseudomonas aeruginosa and other bacteria when compared to SANTYL® sites.
- It is hypothesized that patients will provide significantly higher patient care satisfaction ratings regarding their MEDIHONEY® Gel with Active leptospermum honey sites when compared to ratings with regard to their SANTYL® sites.
- It is hypothesized that treatment costs, across participants, will be significantly lower for MEDIHONEY® Gel with Active leptospermum honey than for SANTYL®.
Detailed description
Researchers have examined the usefulness of honey as a treatment for a variety of wounds. Molan outlines some of the benefits of honey in the treatment of wounds, such as its effective antibacterial activity, debriding action, anti-inflammatory component, and antioxidant activity. In addition, the acidity of honey may improve wound healing by decreasing the pH of the wound and providing more oxygen, which ultimately helps to regenerate tissue .
Many studies have demonstrated the effectiveness of honey's antibacterial properties. For example, the antibacterial activity of honey has been shown to protect against multi-resistant strains of bacteria including multi-resistant staphylococcus aureus (MRSA) and Pseudomonas aeruginosa. In fact, research suggests that honey may be an effective antibacterial agent for bacteria that were resistant to up to 13 different antibiotics. Related specifically to burn injuries, results from another study indicated that honey may be an effective antibacterial agent and treatment option for burn injuries infected with or at risk for infection with Pseudomonas aeruginosa. Furthermore, unlike other antibiotics used in clinical care, the possibility of developing honey-resistant wound pathogens is rare, even when using high concentrations of honey, according to one study. Results from these studies provide strong evidence for the usefulness of honey's antibacterial activity in the treatment of wounds, including burn injuries.
In addition to its antibacterial properties, honey has been found to promote wound healing in patients with burn injuries. For example, one study compared the effectiveness of a honey dressing to silver sulfadiazene (SSD) on wound healing in 78 child and adult burn patients with first and second degree burns. According to the results from this study, patients treated with honey dressings had a significantly lower average duration of healing (in days) compared to patients treated with SSD. In addition, approximately half of the wounds treated with honey dressings became sterile within seven days while none of the wounds became sterile during this span of time for the patients who were treated with SSD. The authors of this study also reported that 30 of the 37 patients (81%) treated with honey achieved complete recovery (i.e., complete healing two months post-burn injury without scarring or contractures) compared to 15 out of 41 patients (37%) treated with SSD. Another study by Baghel and colleagues using a similar sample found comparable results. In this second study, patients who were treated with honey dressings were found to heal significantly faster, have sterile wounds in less time, and have better overall recoveries (i.e., fewer hypertrophic scars and contractures) when compared to those patients who were treated with SSD.
Another study compared honey and SSD on burn wound healing (i.e., improvement in burn wound size and re-epithelialization) in patients with superficial partial thickness burns. Patients included in this study had similar burns (e.g., second degree burns of similar depth) on comparable burned surface areas (e.g., right hand and left hand). In addition, patients in this study received both treatment options; that is, a patient's right hand was treated with honey while his/her left hand was treated with SSD. Results from this study indicated that the average healing time was significantly shorter for the body surfaces treated with honey. Interestingly, the wounds treated with honey were found to heal approximately two days faster than the wounds treated with SSD. Additionally, cultures of the wounds found that only six patients tested positive for Pseudomonas aeruginosa in the sites that were treated with honey compared to 27 patients in the sites treated with SSD. Two additional patients tested positive for Escherichia coli infection in the wound sites that were treated with SSD. The authors of this study concluded that honey was a more effective treatment for superficial partial thickness burns than SSD.
Taken together, these studies provide preliminary evidence that honey may be an effective treatment option for partial thickness burns, with benefits such as faster wound healing and wound sterilization. In addition, MEDIHONEY® is cleared by the FDA to maintain a moist environment conducive to wound healing. However, studies have yet to explore the generalizability of these findings to samples of patients with burn injuries in the United States, as all the previously cited studies were conducted outside of the United States. In addition, studies thus far have examined the effectiveness of honey as a wound treatment and have failed to evaluate patient care satisfaction with honey as a treatment option and the treatment costs associated with the use of honey in clinical care. These two outcomes can provide valuable insight into the appropriateness and feasibility of using honey in everyday clinical care. Overall, information obtained from this study will yield knowledge on the potential benefits of this product for burn wound treatment compared to standard care (i.e., SANTYL®).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medihoney & Santyl | Other | Device: MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY, Device: SantylEach patient will receive both interventions simultaneously, but on non-contiguous parts of the body that each consist of partial thickness burn injuries of similar depth. For example, if a patient presents with bilateral second-degree burns to the lower extremities, one leg will be treated with MEDIHONEY® GEL with Active leptospermum honey dressing, while the other leg will be treated with SANTYL® ointment dressing. MEDIHONEY® is the target treatment for this study, while SANTYL® is standard care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- New patient presenting with a partial thickness burn injury in at least two non-contiguous locations of the body.
- Enrollment will occur within 72 hours of sustaining a burn injury.
Key exclusion criteria (5 listed)
- Cognitive or language barriers that preclude completion of study measures.
- Have burn injuries exceeding 40% total body surface area (TBSA).
- Have a diagnosis of immunodeficiency or kidney disease.
- Are receiving treatment (e.g., chemotherapy, dialysis) that can create concerns with immunodeficiency or affect healing.
- Are pregnant.
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 |
|---|---|---|
| MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEYAlso: MedihoneyMEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY dressing is manufactured by the company Derma Sciences, Inc. and is a moist dressing made of Active Leptospermum Honey (+15) in combination with natural gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing, even in the presence of body heat and fluids. As a percentage of the overall dressing, MEDIHONEY® GEL dressings contains 80% honey. The dressing has a low pH and can help to lower the overall pH of wounds. The dressing also possesses a high osmotic potential, which assists in debridement. | Device | Medihoney & Santyl |
| SantylSANTYL® Ointment is an FDA-approved sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. The enzyme SANTYL® is derived from the fermentation by Clostridium histolyticum. It possesses the unique ability to digest collagen in necrotic tissue. SANTYL® Ointment is indicated for debriding chronic dermal ulcers and severely burned areas. | Device | Medihoney & Santyl |
Primary outcome
Change in Wound Appearance
Time frame: Daily for 7 to 21 days, depending on time it takes burn injury to completely heal
Pictures of wounds and associated "seepage test" paper towels, without indication of date or arm of treatment, were rated by two independent physicians regarding healed or not yet healed. This information was then be used to calculate a "time to heal" variable (# of days) for each patient.
1 secondary outcome
Number of Participants With Presence vs. Absence of Bacteria in Burn Wound
Time frame: Day 7 of study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundMolan PC. The evidence and the rationale for the use of honey as a wound dressing. Wound Practice and Research, 19(4): 204-220, 2011.
- Background: PubMed 19513768Blair SE, Cokcetin NN, Harry EJ, Carter DA. The unusual antibacterial activity of medical-grade Leptospermum honey: antibacterial spectrum, resistance and transcriptome analysis. Eur J Clin Microbiol Infect Dis. 2009 Oct;28(10):1199-208. doi: 10.1007/s10096-009-0763-z. Epub 2009 Jun 10.
- Background: PubMed 25942744George NM, Cutting KF. Antibacterial Honey (Medihoney): in-vitro Activity Against Clinical Isolates of MRSA, VRE, and Other Multiresistant Gram-negative Organisms Including Pseudomonas aeruginosa. Wounds. 2007 Sep;19(9):231-6.
- Background: PubMed 12432313Cooper RA, Halas E, Molan PC. The efficacy of honey in inhibiting strains of Pseudomonas aeruginosa from infected burns. J Burn Care Rehabil. 2002 Nov-Dec;23(6):366-70. doi: 10.1097/00004630-200211000-00002.
- Background: PubMed 20549529Cooper RA, Jenkins L, Henriques AF, Duggan RS, Burton NF. Absence of bacterial resistance to medical-grade manuka honey. Eur J Clin Microbiol Infect Dis. 2010 Oct;29(10):1237-41. doi: 10.1007/s10096-010-0992-1. Epub 2010 Jun 13.
- Background: PubMed 22279383Gupta SS, Singh O, Bhagel PS, Moses S, Shukla S, Mathur RK. Honey dressing versus silver sulfadiazene dressing for wound healing in burn patients: a retrospective study. J Cutan Aesthet Surg. 2011 Sep;4(3):183-7. doi: 10.4103/0974-2077.91249.
- Background: PubMed 20368852Baghel PS, Shukla S, Mathur RK, Randa R. A comparative study to evaluate the effect of honey dressing and silver sulfadiazene dressing on wound healing in burn patients. Indian J Plast Surg. 2009 Jul;42(2):176-81. doi: 10.4103/0970-0358.59276.
- Background: PubMed 20649832Malik KI, Malik MA, Aslam A. Honey compared with silver sulphadiazine in the treatment of superficial partial-thickness burns. Int Wound J. 2010 Oct;7(5):413-7. doi: 10.1111/j.1742-481X.2010.00717.x.
- Individual participant dataSharing planned: No
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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.
Ariel M Aballay, MD principal investigator
Western Pennsylvania Hospital Burn Center
Christina L Duncan, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY and Santyl in people with Burns, run by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 22 May 2019. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Wound Appearance (time frame: Daily for 7 to 21 days, depending on time it takes burn injury to completely heal). 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 NCT02250183, which also lists 8 linked publications.
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 22 May 2019.