Clinical trial NCT03391310: Use of Honey for Pressure Ulcers in Critically Ill Children
Official title: Use of Honey Versus Standard Treatment for Pressure Ulcers in Critically Ill Children- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bed Sore
Pressure Ulcer
Pressure Sore
Critically Ill Children
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Jawaharlal Institute of Postgraduate Medical Education & Research
name: Post Graduate Institute of Medical Education and Research, Chandigarh
First posted: 2018-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All children aged \<17 years admitted to the ICU and developing any stage of pressure ulcer due to mechanical pressure or device related pressure during the PICU stay will be eligible for the study

Exclusion Criteria:

Children with pressure ulcers and

* Who are on more than 1 inotrope would be excluded.
* Having signs of acute wound infection,
* Having wounds with \> 5 cm diameter,
* Having allergy to honey and not willing to give consent would be excluded.

Primary outcomes:
measure: Time to wound healing
timeFrame: Measured upto 12 weeks of onset of ulcer
Secondary outcomes:
measure: Rate of new onset infection of the wound
timeFrame: Measured upto 1 week of onset of ulcer
measure: Rate of treatment failure
timeFrame: Measured upto12 weeks of onset of ulcer
measure: Duration of ICU stay
timeFrame: Measured upto 12 weeks of onset of ulcer
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: St. John's Medical College
state: Karnataka
city: Puducherry
country: India
facility: JIPMER
Study officials:
affiliation: All India Institute of Medical Sciences
name: S K Kabra, MD
role: STUDY_CHAIR
References:
citation: Sankar J, Lalitha AV, Rameshkumar R, Mahadevan S, Kabra SK, Lodha R. Use of Honey Versus Standard Care for Hospital-Acquired Pressure Injury in Critically Ill Children: A Multicenter Randomized Controlled Trial. Pediatr Crit Care Med. 2021 Jun 1;22(6):e349-e362. doi: 10.1097/PCC.0000000000002611.