BurnPhase 2NCT02083900
Use of Banana Leaf Dressing on Donor Site Wounds
A Phase 2 study testing Banana Leaf Dressing and Hydrocolloid Dressing (DuoDERM CGF) in people with Burn, run by University of the Philippines at 1 site in Philippines.
Trial summary
Prospective Randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid dressing. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Burn
- What is being tested?
- Banana Leaf Dressing and Hydrocolloid Dressing (DuoDERM CGF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 sitePhilippines
- Study dates
- Oct 2006to Sep 2007
- Phase
- Phase 2
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient undergoing harvesting of skin graft one or both thigh
- Surgery under general anesthesia
- Given informed consent and has accomplished a written inform consent
Who cannot join
- Patient with uncontrolled medical condition such as diabetes or hypertension
- Pregnant females
- Patients in whom legs or back was used as donor site
- Surgery under regional anesthesia
- Refused inclusion into the study
- Patients who had previous skin harvesting on the area of the study
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: Use of Banana Leaf Dressing on Donor Site Wounds: A Prospective Randomized Control Study
Prospective Randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid dressing.
Read the detailed description
Prospective Randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid dressing.
Adult patients with no uncontrolled medical condition admitted at Philippine General Hospital Burn Center requiring split thickness skin graft for their burn. this is to compare the efficacy and safety of Banana Leaf Dressing with Hydrocolloid dressing among patients undergoing split thickness skin graft for their burn.
- Conditions
- Burn
- Being tested
- Banana Leaf Dressing, Hydrocolloid Dressing (DuoDERM CGF)
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Banana Leaf DressingDevice
Banana leaf dressing will be prepared by cutting the mid rib of the leaf cutting the leaf into standard size of 12 x 12 inches to facilitate packing. The leaves are rolled and packed in polypropelene bags and subject to gamma irradiation or packed in paper bags for autoclaving. The Banana Leaf Dressing site will receive a single layer of banana leaf without any topical antibiotic applied to the wound followed by a layer of dry gauze for absorption of exudates. The dressing is secured with cling wrap to maintain an occlusive environment. This is then covered by rolled gauze and elastic bandage.
Hydrocolloid Dressing (DuoDERM CGF)Drug
Also called DuoDERM CGF
The donor under HCD was covered with hydrocolloid (DuoDERM CGF). The hydrocolloid dressing was cut to the size of the donor site with an overlap of at least 2 centimeter around the wound edge. After pulling off the adhesive backing, care was taken to ensure that the adhesive was in direct contact with the raw surface. This was likewise covered with a top dressing of gauze for absorption of exudates and an elastic bandage to secure dressing.
| Study group | Role | What they receive |
|---|---|---|
| Banana Leaf Dressing Group | Experimental | The Banana Leaf Dressing site will receive a single layer of banana leaf dressing Receives: Device: Banana Leaf Dressing |
| Hydrocolloid Dressing Arm | Active comparator | The donor under Hydrocolloid dressing was covered with hydrocolloid (DuoDERM CGF). Receives: Drug: Hydrocolloid Dressing (DuoDERM CGF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Assessment and Efficacy of the dressing
After 8th post harvest day The degree of healing will be assessed. Direct inspection of the wound will be made by experienced burn surgeon. The degree of re-epithelialization will be graded as follow:
No Re-epithelialization = zero (0); Less than 50% = one (1); More than 50% but not complete = Two (2), and Complete (90% or more) = Three (3). Complete Re-epithelialization is synonymous to healing on which 90% or more of the wound surface is re-epithelialized.
Measured: 8th post harvest day
Secondary outcomes (1)
Pain Scores
This pain score shall be determined on each patient using a visual analog pain intensity scale the score is as follows: 0-1=no pain; 2-3= Mild pain; 4-5=Moderate pain; 7-8= Severe pain; 9-10=Worst possible.
Measured: taken from 24hours, on the 48th and 72 hour post skin harvest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startOct 2006
- Primary completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Philippines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeane Azarcon, MD, Principal investigator, UP Manila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083900
- Sponsor's protocol ID
- NIH (TRB) 2005-002
- Status last verified
- Apr 2020
- First submitted
- 24 Feb 2014
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Banana Leaf Dressing on Donor Site Wounds: A Prospective Randomized Control Study
- ClinicalTrials.gov ID
- NCT02083900
- Acronym / sponsor ID
- NIH (TRB) 2005-002
- Conditions
- Burn
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of the PhilippinesUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Sep 2007 (actual)
- First posted
- 11 Mar 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.
Prospective Randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid dressing.
Detailed description
Prospective Randomized double-blind controlled trial comparing the healing rate, infection rate, pain score, ease of care and scar formation of Banana leaf dressing versus hydrocolloid dressing.
Adult patients with no uncontrolled medical condition admitted at Philippine General Hospital Burn Center requiring split thickness skin graft for their burn. this is to compare the efficacy and safety of Banana Leaf Dressing with Hydrocolloid dressing among patients undergoing split thickness skin graft for their burn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Banana Leaf Dressing Group | Experimental | Device: Banana Leaf DressingThe Banana Leaf Dressing site will receive a single layer of banana leaf dressing |
| Hydrocolloid Dressing Arm | Active comparator | Drug: Hydrocolloid Dressing (DuoDERM CGF)The donor under Hydrocolloid dressing was covered with hydrocolloid (DuoDERM CGF). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient undergoing harvesting of skin graft one or both thigh
- Surgery under general anesthesia
- Given informed consent and has accomplished a written inform consent
Key exclusion criteria (6 listed)
- Patient with uncontrolled medical condition such as diabetes or hypertension
- Pregnant females
- Patients in whom legs or back was used as donor site
- Surgery under regional anesthesia
- Refused inclusion into the study
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 |
|---|---|---|
| Banana Leaf DressingBanana leaf dressing will be prepared by cutting the mid rib of the leaf cutting the leaf into standard size of 12 x 12 inches to facilitate packing. The leaves are rolled and packed in polypropelene bags and subject to gamma irradiation or packed in paper bags for autoclaving. The Banana Leaf Dressing site will receive a single layer of banana leaf without any topical antibiotic applied to the wound followed by a layer of dry gauze for absorption of exudates. The dressing is secured with cling wrap to maintain an occlusive environment. This is then covered by rolled gauze and elastic bandage. | Device | Banana Leaf Dressing Group |
| Hydrocolloid Dressing (DuoDERM CGF)Also: DuoDERM CGFThe donor under HCD was covered with hydrocolloid (DuoDERM CGF). The hydrocolloid dressing was cut to the size of the donor site with an overlap of at least 2 centimeter around the wound edge. After pulling off the adhesive backing, care was taken to ensure that the adhesive was in direct contact with the raw surface. This was likewise covered with a top dressing of gauze for absorption of exudates and an elastic bandage to secure dressing. | Drug | Hydrocolloid Dressing Arm |
Primary outcome
Healing Assessment and Efficacy of the dressing
Time frame: 8th post harvest day
After 8th post harvest day The degree of healing will be assessed. Direct inspection of the wound will be made by experienced burn surgeon. The degree of re-epithelialization will be graded as follow: No Re-epithelialization = zero (0); Less than 50% = one (1); More than 50% but not complete = Two (2), and Complete (90% or more) = Three (3). Complete Re-epithelialization is synonymous to healing on which 90% or more of the wound surface is re-epithelialized.
1 secondary outcome
Pain Scores
Time frame: taken from 24hours, on the 48th and 72 hour post skin harvest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
Related trials for Burn
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
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.
Jeane Azarcon, MD principal investigator
UP Manila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Banana Leaf Dressing and Hydrocolloid Dressing (DuoDERM CGF) in people with Burn, 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 3 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: status not confirmed, as of the sponsor's last update on 24 Apr 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Healing Assessment and Efficacy of the dressing (time frame: 8th post harvest day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2020.