NCT03391310

Use of Honey for Pressure Ulcers in Critically Ill Children

Completed NA Last updated 9 January 2019

What this trial tests

NA trial testing Honey (medicated) in Bed Sore in 100 participants. Completed in 30 December 2018.

Timeline

2 September 2017

Primary endpoint
30 December 2018

30 December 2018

Quick facts

Lead sponsor	All India Institute of Medical Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	2 September 2017
Primary completion	30 December 2018
Estimated completion	30 December 2018
Sites	2 locations across India

Drugs / interventions tested

• Honey (medicated)

Conditions studied

• Bed Sore — all drugs for Bed Sore →
• Pressure Ulcer — all drugs for Pressure Ulcer →
• Pressure Sore — all drugs for Pressure Sore →
• Critically Ill Children — all drugs for Critically Ill Children →

Sponsor

All India Institute of Medical Sciences

Who can join

Adults 2 Months to 17, any sex, with Bed Sore or Pressure Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evidence for Natural Products as Alternative Wound-Healing Therapies.
   Moses RL, Prescott TAK, Mas-Claret E, Steadman R, et al · · 2023 · cited 17× · PMID 36979379 · DOI 10.3390/biom13030444
2. ABSTRACTS CRITICARE – IJCCM2021
   · 2021