Use of Honey for Pressure Ulcers in Critically Ill Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Honey Versus Standard Treatment for Pressure Ulcers in Critically Ill Children- A Randomized Controlled Trial

Conditions
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Bed Sore, Pressure Ulcer, Pressure Sore, Critically Ill Children

Intervention / Treatment
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* Other: Honey (medicated)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Honey dressing group<br>In this group, the wound will be cleaned with normal saline and then honey (medicated ) will be applied to cover the wound surface. The dressing will be changed once soiled (alternate day in most cases). The dressing will be applied for a maximum period upto 8 weeks (in cases of stage IV ulcers) or till healthy granulation tissue appears, whichever is earlier. | Other: Honey (medicated)<br>* Honey (medicated) dressing will be used in the experimental group<br>* Other names: Leptospermum honey;|
| No Intervention: Standard treatment group<br>In this group, the wound will be first cleaned with 'povidone iodine' and then covered with hydrocolloid dressing changed alternate day for maximum period upto 8 weeks (in cases of stage IV ulcers) or till healthy granulation tissue appears, whichever is earlier. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to wound healing | Time to healing of stage 1 to 3 of pressure sore | Measured upto 12 weeks of onset of ulcer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of new onset infection of the wound | Wound infection | Measured upto 1 week of onset of ulcer | 
| Rate of treatment failure | Wound does not heal | Measured upto12 weeks of onset of ulcer | 
| Duration of ICU stay | Length of stay in PICU in days | Measured upto 12 weeks of onset of ulcer |