SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty

NCT05919888 | Completed Phase 4 Results FDA Drug FDA Device

• 1 other identifier: 32325
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus antimicrobial wound gel versus betadine applied to the skin layer after the skin incision has been made. Reducing the bacteria present in the deep tissues at the end of the surgery may prevent infections from developing in the future.

Conditions

Surgery; Surgical Site Infection; Cutibacterium Acnes; Prosthetic-joint Infection

Keywords

Antimicrobial wound gel; SURGX; Betadine; Dermal layer; Skin preparation

Outcome Measures

Primary Outcomes (2)

• Presence of Bacteria Within Shoulder Culture Using Incisional Prep vs. no Prep

  Each participant had culture swabs at end of surgical case from deep, superficial, and implant locations. Cultures were held in the lab for 2 weeks to evaluate for the presence of bacteria. The number of patients with at least one positive culture were compared among the three study arms.

  Day 14

• Presence of Bacteria Within Shoulder Culture Using Incisional Prep vs. no Prep

  Each participant had 5 total culture swabs at end of surgical case from deep (2), superficial (2), and implant (1) locations. Cultures were held in the lab for 2 weeks to evaluate for the presence of bacteria. The number of positive cultures after 2 weeks were compared among the control group and SURGX group.

  Day 14

Secondary Outcomes (1)

• Presence of Bacteria Within Shoulder Culture Using SURGX Wound Gel Prep vs. Povidone-iodine Prep

  Day 14

Study Arms (3)

No skin incision preparation

NO INTERVENTION

All patients will receive standard pre-operative prophylactic antibiotics. Participants will all receive the same preoperative external skin preparation with Hibiclens (chlorhexidine) and ChloraPrep (2% chlorhexidine gluconate / 70% isopropyl alcohol solution) prior to draping. Intra-operative irrigation will be standardized with Irrisept (chlorhexidine gluconate 0.05% in sterile water). The control group will receive no dermal layer skin preparation. At the time of the surgery, after the skin incision has been made with a skin knife, the dermal layer will not be prepped with an agent.

Povidone-iodine

ACTIVE COMPARATOR

At the time of the surgery, after the skin incision has been made, the dermal layer be prepped with povidone-iodine. Drug: povidone-iodine Dose: swabstick Administration: swab the incision Frequency: once

Drug: Povidone-Iodine

SURGX Wound Gel

EXPERIMENTAL

At the time of the surgery, after the skin incision has been made, the dermal layer be prepped with SURGX Wound Gel. SURGX wound gel is a topical antiseptic gel agent to be used on surgical incisions to prevent bacterial infection.

Device: SURGX Wound Gel

Interventions

Povidone-Iodine DRUG

Applied to skin incision.

Also known as: Betadine

Povidone-iodine

SURGX Wound Gel DEVICE

Applied to skin incision.

SURGX Wound Gel

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is planned to undergo elective primary anatomic or reverse shoulder arthroplasty.

You may not qualify if:

• Patient is undergoing revision shoulder replacement surgery.
• Patient has a known allergy to iodine, benzalkonium chloride, or polythylene glycol.

Sponsors & Collaborators

• St. Louis University: lead
• Next Science LLC: collaborator

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Dr. Randall Otto
• Organization: SSMHealth SLUCare Physician Group

randall.otto@slucare.ssmhealth.com

314-614-2970

Study Officials

• Randall Otto, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 26, 2023
• Study Start: June 26, 2023
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2024-11

Locations

US (1)