Use of Honey for Pressure Ulcers in Critically Ill Children

NCT03391310 | Completed DMC

• 1 other identifier: 110/03.03.2017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Bed Sore; Pressure Ulcer; Pressure Sore; Critically Ill Children

Outcome Measures

Primary Outcomes (1)

• Time to wound healing

  Time to healing of stage 1 to 3 of pressure sore

  Measured upto 12 weeks of onset of ulcer

Secondary Outcomes (3)

• Rate of new onset infection of the wound

  Measured upto 1 week of onset of ulcer

• Rate of treatment failure

  Measured upto12 weeks of onset of ulcer

• Duration of ICU stay

  Measured upto 12 weeks of onset of ulcer

Study Arms (2)

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.

Other: Honey (medicated)

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.

Interventions

Honey (medicated) OTHER

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

Also known as: Manuka honey, Leptospermum honey

Honey dressing group

Eligibility Criteria

• Age: 2 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jawaharlal Institute of Postgraduate Medical Education & Research: collaborator
• All India Institute of Medical Sciences: lead
• Post Graduate Institute of Medical Education and Research, Chandigarh: collaborator

Study Sites (2)

St. John's Medical College

Bengaluru, Karnataka, 560034, India

Location

JIPMER

Puducherry, 605006, India

Location

Related Publications (1)

• 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.

  PMID: 33181730 DERIVED

Related Links

• Clinical Trials Registry of India - Registered trial

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Honey

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• S K Kabra, MD

  All India Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: RCT

Study Record Dates

• First Submitted: August 18, 2017
• First Posted: January 5, 2018
• Study Start: September 2, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: January 9, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)