Comparison of Subcutaneous Injection of Normal Saline and Bacteriostatic Saline

NCT05109000 | Unknown Phase 4 FDA Drug

• 1 other identifier: NS vs. BS
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, single-center clinical trial comparing normal saline and bacteriostatic saline subcutaneous injection within a single subject. While both normal saline and bacteriostatic saline can be administered intravenously, this study aims to investigate their effects following subcutaneous injection. While benzyl alcohol (the bacteriostatic component of bacteriostatic saline) is known to have local anesthetic properties, it also is an irritant and can cause inflammation at the injection site. Based on clinical experience investigators anticipate that a normal saline injection will cause a mild stinging sensation and no subsequent inflammation. In contrast, subcutaneous injection of bacteriostatic saline will not cause stinging but will cause a mild degree of inflammation which is manifested as mild tenderness and mild ecchymosis at the site of injection.

Conditions

Injection Site Irritation; Injection Site Bruising; Injection Site Discomfort; Benzoic Acid Adverse Reaction; Anesthesia, Local

Keywords

normal saline; bacteriostatic saline; subcutaneous injection

Outcome Measures

Primary Outcomes (21)

• Injection Pain

  Numerical Pain Score (NPS): 0-10

  Time Post-Injection: 0 minutes

• Erythema

  Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)

  Time Post-Injection: 5 minutes

• Erythema

  Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)

  Time Post-Injection: 1 hour

• Erythema

  Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)

  Time Post-Injection: 24 hours

• Erythema

  Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)

  Time Post-Injection: 48 hours

• Erythema

  Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)

  Time Post-Injection: 7 days

• Bruising

  Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)

  Time Post-Injection: 5 minutes

• Bruising

  Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)

  Time Post-Injection: 1 hour

• Bruising

  Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)

  Time Post-Injection: 24 hours

• Bruising

  Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)

  Time Post-Injection: 48 hours

• Bruising

  Intensity by visual objective assessment: none (0), mild (1), moderate (2), intense (3)

  Time Post-Injection: 7 days

• Tenderness

  Numerical Pain Score (NPS): 0-10

  Time Post-Injection: 5 minutes

• Tenderness

  Numerical Pain Score (NPS): 0-10

  Time Post-Injection: 1 hour

• Tenderness

  Numerical Pain Score (NPS): 0-10

  Time Post-Injection: 24 hours

• Tenderness

  Numerical Pain Score (NPS): 0-10

  Time Post-Injection: 48 hours

• Tenderness

  Numerical Pain Score (NPS): 0-10

  Time Post-Injection: 7 days

• Soreness

  Numerical Pain Score (NPS): 0-10

  Time Post-Injection: 5 minutes

• Soreness

  Numerical Pain Score (NPS): 0-10

  Time Post-Injection: 1 hour

• Soreness

  Numerical Pain Score (NPS): 0-10

  Time Post-Injection: 24 hours

• Soreness

  Numerical Pain Score (NPS): 0-10

  Time Post-Injection: 48 hours

• Soreness

  Numerical Pain Score (NPS): 0-10

  Time Post-Injection: 7 days

Study Arms (2)

Normal Saline

EXPERIMENTAL

This is a randomized, double-blind, single-center clinical trial comparing normal saline and bacteriostatic saline subcutaneous injection within a single subject. In this arm, the subject will receive a 10 mL subcutaneous injection of normal saline into either their left or right anterior thigh. The side will be determined by randomization protocol.

Drug: Sodium Chloride 0.9% Inj

Bacteriostatic Saline

EXPERIMENTAL

This is a randomized, double-blind, single-center clinical trial comparing normal saline and bacteriostatic saline subcutaneous injection within a single subject. In this arm, the subject will receive a 10 mL subcutaneous injection of bacteriostatic saline into either their left or right anterior thigh. The side will be determined by randomization protocol.

Drug: Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML)

Interventions

Sodium Chloride 0.9% Inj DRUG

10 mL subcutaneous injection into one randomized anterior thigh of subject

Also known as: normal saline

Normal Saline

Bacteriostatic Sodium Chloride 0.9 % INJECTION VIAL (ML) DRUG

10 mL subcutaneous injection into the contralateral anterior thigh of subject

Also known as: bacteriostatic saline

Bacteriostatic Saline

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All volunteer subjects will be healthy, mature in behavior and temperament, and without mental impairment.
• A volunteer must have signed an informed consent form prior to participation.
• A subject must be at least 16 years of age.
• All subjects must weigh at least 40kg = 88lb.
• All subjects must complete a standard medical history questionnaire.
• All subjects must agree to return for a follow-up examination, 1 day, 2 days, and 1-week post-injections.

You may not qualify if:

• Pregnant women are excluded.
• History of an adverse reaction to percutaneous injections, such as fainting and lightheadedness (vasovagal reactions, near syncope).
• Significant needle phobia or anxiety.
• Vasovagal reaction associated with any medical procedures or the sight of blood.
• History of having or having had a blood-born infection with HIV, Hepatitis B, Hepatitis C.
• Evidence of active skin infection.
• History of radiation therapy or surgery involving the area near the proposed injection site.
• Uncontrolled or labile hypertension.

Sponsors & Collaborators

• Jeffrey Alan Klein, MD: lead

Study Sites (1)

HK Dermatology

San Juan Capistrano, California, 92675, United States

Location

MeSH Terms

Interventions

Sodium Chloride; Saline Solution

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Claire M Richards

CONTACT

9493904965; crichards7899@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Founder and CEO, Physician

Model Details: Subjects will receive both treatments: one in each thigh. Random allocation of subcutaneous injections of 10 mL of normal saline into one anterior thigh and 10 mL of bacteriostatic saline into the contralateral anterior thigh. Paired t-tests to compare the clinical effects of the two solutions.

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 5, 2021
• Study Start: November 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)