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Use of Honey for Pressure Ulcers in Critically Ill Children

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ClinicalTrials.gov Identifier: NCT03391310
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : June 21, 2018
Sponsor:
Collaborators:
Jawaharlal Institute of Postgraduate Medical Education & Research
Postgraduate Institute of Medical Education and Research
Information provided by (Responsible Party):
Jhuma Sankar, All India Institute of Medical Sciences, New Delhi

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.

Condition or disease Intervention/treatment Phase
Bed Sore Pressure Ulcer Pressure Sore Critically Ill Children Other: Honey (medicated) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Honey Versus Standard Treatment for Pressure Ulcers in Critically Ill Children- A Randomized Controlled Trial
Actual Study Start Date : September 2, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

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:
  • Manuka honey
  • Leptospermum 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.



Primary Outcome Measures :
  1. Time to wound healing [ Time Frame: Measured upto 12 weeks of onset of ulcer ]
    Time to healing of stage 1 to 3 of pressure sore


Secondary Outcome Measures :
  1. Rate of new onset infection of the wound [ Time Frame: Measured upto 1 week of onset of ulcer ]
    Wound infection

  2. Rate of treatment failure [ Time Frame: Measured upto12 weeks of onset of ulcer ]
    Wound does not heal

  3. Duration of ICU stay [ Time Frame: Measured upto 12 weeks of onset of ulcer ]
    Length of stay in PICU in days



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Ages Eligible for Study:   2 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391310


Contacts
Contact: Jhuma Sankar, MD +911126546784 jhumaji@gmail.com
Contact: Rakesh Lodha, MD _911126593621 rlodha1661@gmail.com

Locations
India
St. John's Medical College Recruiting
Bengaluru, Karnataka, India, 560034
Contact: Lalitha AV, MD    9448461673    drlalitha04@yahoo.com   
JIPMER Recruiting
Puducherry, India, 605006
Contact: Ramesh Kumar, DM       krramesh_iway@yahoo.co.in   
Sub-Investigator: Mahadevan Subramanian, MD         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Jawaharlal Institute of Postgraduate Medical Education & Research
Postgraduate Institute of Medical Education and Research
Investigators
Study Chair: S K Kabra, MD All India Institute of Medical Sciences, New Delhi

Additional Information:
Responsible Party: Jhuma Sankar, Assistant Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT03391310     History of Changes
Other Study ID Numbers: 110/03.03.2017
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ulcer
Critical Illness
Pressure Ulcer
Pathologic Processes
Disease Attributes
Skin Ulcer
Skin Diseases