Use of Honey for Pressure Ulcers in Critically Ill Children

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391310
• Other study ID #: 110/03.03.2017
• Status: Completed
• Phase: N/A
• Start date: September 2, 2017
• Est. completion date: December 30, 2018

Study information

• Verified date: January 2019
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bed Sore
• Critical Illness
• Critically Ill Children
• Pressure Sore
• Pressure Ulcer
• Ulcer

Intervention

Other:
• Honey (medicated)
Honey (medicated) dressing will be used in the experimental group

Locations

Country	Name	City	State
India	St. John's Medical College	Bengaluru	Karnataka
India	JIPMER	Puducherry

Sponsors (3)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi	Jawaharlal Institute of Postgraduate Medical Education & Research, Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to wound healing	Time to healing of stage 1 to 3 of pressure sore	Measured upto 12 weeks of onset of ulcer
Secondary	Rate of new onset infection of the wound	Wound infection	Measured upto 1 week of onset of ulcer
Secondary	Rate of treatment failure	Wound does not heal	Measured upto12 weeks of onset of ulcer
Secondary	Duration of ICU stay	Length of stay in PICU in days	Measured upto 12 weeks of onset of ulcer

External Links

•   Clinical Trials Registry of India - Registered trial