Wound Irrigation Comparative Effectiveness Study

Conditions

• Cutibacterium Acnes Contamination

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Irrisept Irrigation — PROCEDURE
  Irrisept Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device. Irrisept contains 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United Staes Pharmacopeia (USP). The solution is aseptically filled in a Blow-Fill-Seal (BFS) bottle.
• Saline Irrigation Solution Delivery — PROCEDURE
  Normal saline is isotonic and the most commonly used wound irrigation solution due to safety (lowest toxicity) and physiologic factors.

Study Details

The primary objective of this study is to compare the presence of C acnes in bacteriologic cultures taken from participant samples of subcutaneous and deep tissue prior to deep surgical irrigation using either Normal Saline Irrigation (Group 1) or Irrisept Irrigation (Group 2). Secondary objectives are evaluation of patient reported outcome measures and range of motion in relation to C acnes presence among subjects in the two groups.

Key Dates

Start date

Mar 20, 2024

Status verified

Apr 2024

Primary completion

May 31, 2025

Completion

May 31, 2027

Study Design

Enrollment

126 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Normal Saline Irrigation Arm (Group 1)
  After deep dissection, and prior to implantation of components, 100 cc of normal saline will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points.
• Active Comparator: Irrisept irrigation Arm (Group 2)
  After deep dissection, and prior to implantation of components, 100 cc of Irrisept solution will be irrigated into the deep wound and progress outward through more superficial planes to the skin. Cultures will then be taken at multiple wound depths and time points.

Primary Outcome Measure

C Acnes Presence [ Time Frame: Cultures take during surgery and analyzed over 21 days post surgery ]

Central Contacts

• Vance Gardner, MD
  (949) 526-1570
  [email protected]

Locations (1)

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