Honey (medicated)
OtherHoney (medicated) dressing will be used in the experimental group
Other names: Manuka honey, Leptospermum honey
NCT Number: NCT03391310
The enrolled children would be randomized to one of the groups 'study group' or 'Honey dressing group' or 'Group I' (honey dressing containing Active Leptospermum Honey also known as Manuka honey would be used), changed every alternate day for a maximum period of upto 8 weeks (in cases of stage IV ulcers) or till healthy granulation tissue appears, whichever is earlier and 'control group' or 'Standard treatment group ' or 'Group 2' (paraffin gauze is applied after application of povidone iodine). Randomization will be performed as per protocol. Primary outcome will be reduction in time to healing of any stage of pressure ulcer and secondary outcomes will be treatment failure and new onset infection of ulcer.
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Notify Me2 month–17 year
All sexes
Interventional
Not applicable
St. John's Medical College, Bengaluru, Karnataka, India
Children admitted to the PICU would be eligible for inclusion. The interventions will be initiated within the hospital itself. All children will be managed as per standard treatment protocols of the unit for various disease conditions. The enrolled children would be randomized to one of the groups 'study group' or 'Honey dressing group' or 'Group I' (honey dressing containing Active Leptospermum Honey also known as Manuka honey would be used), changed every alternate day for a maximum period of upto 8 weeks (in cases of stage IV ulcers) or till healthy granulation tissue appears, whichever is earlier and 'control group' or 'Standard treatment group ' or 'Group 2' (paraffin gauze is applied after application of povidone iodine). Randomization will be performed as per protocol. Primary outcome will be reduction in time to healing of any stage of pressure ulcer and secondary outcomes will be treatment failure rate and new onset infection of ulcer. The investigators ICU is a fully equipped 8 bedded ICU with all ventilated beds. There are 2 full time consultants, residents and staff with nurse patient ratio of 1:1 to 1:2. Therefore, the investigators are well equipped to treat critically ill children. There will be an in-built mechanism of assuring quality of processes at different steps.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Children with pressure ulcers and
Honey (medicated) dressing will be used in the experimental group
Other names: Manuka honey, Leptospermum honey
Time frame: Measured upto 12 weeks of onset of ulcer
Time to healing of stage 1 to 3 of pressure sore
Time frame: Measured upto 1 week of onset of ulcer
Wound infection
Time frame: Measured upto12 weeks of onset of ulcer
Wound does not heal
Time frame: Measured upto 12 weeks of onset of ulcer
Length of stay in PICU in days
All India Institute of Medical Sciences
Other
Use of Honey Versus Standard Treatment for Pressure Ulcers in Critically Ill Children- A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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