Use of Honey for Pressure Ulcers in Critically Ill Children

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

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.

Study Overview

• Status: Completed
• Conditions: Pressure Ulcer; Critically Ill Children; Pressure Sore; Bed Sore
• Intervention / Treatment: Other: Honey (medicated)

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Puducherry, India, 605006
    • JIPMER
  • Karnataka
    • Bengaluru, Karnataka, India, 560034
      • St. John's Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Honey dressing group; 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); Honey (medicated) dressing will be used in the experimental group; Other Names: Leptospermum honey; Manuka honey
NO_INTERVENTION: Standard treatment group; 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?

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

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborators: Postgraduate Institute of Medical Education and Research; Jawaharlal Institute of Postgraduate Medical Education & Research

Publications and helpful links

General Publications

• 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.

Helpful Links

• Clinical Trials Registry of India - Registered trial

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 2, 2017
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): December 30, 2018

Study Registration Dates

• First Submitted: August 18, 2017
• First Submitted That Met QC Criteria: January 4, 2018
• First Posted (ACTUAL): January 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Skin Ulcer; Ulcer; Critical Illness; Pressure Ulcer
• Other Study ID Numbers: 110/03.03.2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No