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| Name | Class |
|---|---|
| Jawaharlal Institute of Postgraduate Medical Education & Research | OTHER_GOV |
| Post Graduate Institute of Medical Education and Research, Chandigarh | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Honey dressing group | Experimental | 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. |
|
| Standard treatment group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Honey (medicated) | Other | Honey (medicated) dressing will be used in the experimental group |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Children with pressure ulcers and
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| Name | Affiliation | Role |
|---|---|---|
| S K Kabra, MD | All India Institute of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. John's Medical College | Bengaluru | Karnataka | 560034 | India | ||
| JIPMER |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33181730 | Derived | 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. |
| Label | URL |
|---|---|
| Clinical Trials Registry of India - Registered trial | View source |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D006722 | Honey |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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RCT
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| 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 |
| Puducherry |
| 605006 |
| India |