Bed Sore, Critically Ill Children, Pressure Sore, Pressure Ulcer
Conditions
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.
Interventions
OTHERHoney (medicated)
Honey (medicated) dressing will be used in the experimental group
Sponsors
Jawaharlal Institute of Postgraduate Medical Education & Research
Post Graduate Institute of Medical Education and Research, Chandigarh
All India Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
RCT
Eligibility
Sex/Gender
ALL
Age
2 Months to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to wound healing | Measured upto 12 weeks of onset of ulcer | Time to healing of stage 1 to 3 of pressure sore |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of new onset infection of the wound | Measured upto 1 week of onset of ulcer | Wound infection |
| Rate of treatment failure | Measured upto12 weeks of onset of ulcer | Wound does not heal |
| Duration of ICU stay | Measured upto 12 weeks of onset of ulcer | Length of stay in PICU in days |
Countries
India
Outcome results
None listed