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Use of Honey for Pressure Ulcers in Critically Ill Children

Primary Purpose

Bed Sore, Pressure Ulcer, Pressure Sore

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Honey (medicated)
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bed Sore

Eligibility Criteria

2 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. John's Medical College
  • JIPMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Honey dressing group

Standard treatment group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to wound healing
Time to healing of stage 1 to 3 of pressure sore

Secondary Outcome Measures

Rate of new onset infection of the wound
Wound infection
Rate of treatment failure
Wound does not heal
Duration of ICU stay
Length of stay in PICU in days

Full Information

First Posted
August 18, 2017
Last Updated
January 8, 2019
Sponsor
All India Institute of Medical Sciences, New Delhi
Collaborators
Jawaharlal Institute of Postgraduate Medical Education & Research, Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT03391310
Brief Title
Use of Honey for Pressure Ulcers in Critically Ill Children
Official Title
Use of Honey Versus Standard Treatment for Pressure Ulcers in Critically Ill Children- A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
Collaborators
Jawaharlal Institute of Postgraduate Medical Education & Research, Postgraduate Institute of Medical Education and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bed Sore, Pressure Ulcer, Pressure Sore, Critically Ill Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Honey dressing group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard treatment group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Honey (medicated)
Other Intervention Name(s)
Manuka honey, Leptospermum honey
Intervention Description
Honey (medicated) dressing will be used in the experimental group
Primary Outcome Measure Information:
Title
Time to wound healing
Description
Time to healing of stage 1 to 3 of pressure sore
Time Frame
Measured upto 12 weeks of onset of ulcer
Secondary Outcome Measure Information:
Title
Rate of new onset infection of the wound
Description
Wound infection
Time Frame
Measured upto 1 week of onset of ulcer
Title
Rate of treatment failure
Description
Wound does not heal
Time Frame
Measured upto12 weeks of onset of ulcer
Title
Duration of ICU stay
Description
Length of stay in PICU in days
Time Frame
Measured upto 12 weeks of onset of ulcer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S K Kabra, MD
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Study Chair
Facility Information:
Facility Name
St. John's Medical College
City
Bengaluru
State/Province
Karnataka
ZIP/Postal Code
560034
Country
India
Facility Name
JIPMER
City
Puducherry
ZIP/Postal Code
605006
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33181730
Citation
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.
Results Reference
derived
Links:
URL
http://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=17812&EncHid=25152.16814&modid=1&compid=19
Description
Clinical Trials Registry of India - Registered trial

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Use of Honey for Pressure Ulcers in Critically Ill Children

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