Microbiologic Alterations of the Conjunctiva of Hot Tub-soaking Ophthalmologists

NCT03987178 | Completed

• 1 other identifier: 18-26141
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if there are microbiologic alterations of the ocular surface after hot tub exposure. The study will evaluate the number of microbes before and after hot tub use in order to find out whether hot tub exposure has any change on the organisms present on the ocular surface. Participants will be randomized to dunk or not to dunk their head during their time in the hot tub.

Conditions

Conjunctivitis, Bacterial; Keratitis Bacterial

Keywords

hot tub; conjunctival cultures; bacterial keratitis

Outcome Measures

Primary Outcomes (1)

• Quantity of organisms

  Genus-species will be identified for each sample, and quantified with an ordinal scale (0-4). The total of this score will be the quantity for that person-time. The primary analyses will be a Wilcoxon Rank Sum test (Mann-Whitney) between the two arms at the follow-up time point (randomized comparison of dunk vs no-dunk), and a Wilcoxon Signed Rank test between pre-hot-tub and post-hot-tub (longitudinal comparison of all cases). We estimate that a total of 20 subjects will provide 80% power to detect a 1.25 SD difference in the total quantity score between randomization arms at the post (f/u) time point. We estimate 80% power to detect a .9 SD difference between pre (baseline) and post (f/u) time points in a paired longitudinal analysis.

  1 year

Secondary Outcomes (6)

• Richness (number of species per sample) of organisms found in the conjunctiva with hot tub use (post-test comparison)

  1 year

• Richness (number of species per sample) of organisms found in the conjunctiva with hot tub use (pre versus post)

  1 year

• Difference in organism profile with hot tub use (pre versus post)

  1 year

• Difference in organism profile with hot tub use (between arms)

  1 year

• Quantity comparing pre-hot tub and post-hot tub swabs

  1 year

Study Arms (2)

Head Dunk

EXPERIMENTAL

Subjects who are assigned to be in this arm are asked to sit in a hot tub for 15 minutes and instructed to submerge his or her head in the hot tub at least once and at least up to the eyebrows during his or her time in the hot tub.

Behavioral: Dunk; Other: Exposure to Hot Tub

No Head Dunk

PLACEBO COMPARATOR

Subjects assigned to this arm are asked to sit in a hot tub for 15 minutes but to keep his or her chin above water during the entire time.

Other: Exposure to Hot Tub

Interventions

Dunk BEHAVIORAL

If randomized to "Dunk," the subject is asked to submerge his or her head in the hot tub at least up to brow level.

Head Dunk

Exposure to Hot Tub OTHER

Subjects will be asked to sit in a hot tub for 15 minutes (with an individual timer).

Head Dunk; No Head Dunk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• greater of 18 years of age
• a willing participant
• healthy

You may not qualify if:

• pregnancy
• high or low blood pressure
• active diarrhea
• lymphedema
• heart disease
• seizure disorder.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF

San Francisco, California, 94122, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Bacterial

Interventions

dunk protein, Drosophila

Condition Hierarchy (Ancestors)

Eye Infections, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Eye Infections; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Officials

• Gerami D Seitzman, MD

  UCSF/Proctor Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A provider is assigned to perform conjunctival swabs; this person is completely masked to exposure. The culture plates, which are randomized, are sent to a microbiology lab and the technicians are completely masked to exposures when reading the plates.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 14, 2019
• Study Start: May 27, 2019
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)