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SURGX Wound Gel for Surgical Site Infection

Phase 4

Waitlist Available

Led By Randall Otto, MD

Research Sponsored by St. Louis University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks following surgery

Awards & highlights

Study Summary

This trial tested how different treatments reduce bacteria in shoulder surgery, helping to prevent infection.

Eligible Conditions

Surgery
Surgical Site Infection
Prosthetic Joint Infection
Acne

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks following surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Positive culture as determined by the presence of Cutibacterium acnes (C. acnes) - Deep

Positive culture as determined by the presence of Cutibacterium acnes (C. acnes) - Implant

Positive culture as determined by the presence of Cutibacterium acnes (C. acnes) - Superficial

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: SURGX Wound GelExperimental Treatment1 Intervention

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.

Group II: No skin incision preparationActive Control1 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.

Group III: Povidone-iodineActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SURGX Wound Gel

2023

Completed Phase 4

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Next Science LLCUNKNOWN

2 Previous Clinical Trials

133 Total Patients Enrolled

St. Louis UniversityLead Sponsor

194 Previous Clinical Trials

43,595 Total Patients Enrolled

1 Trials studying Surgery

83 Patients Enrolled for Surgery

Randall Otto, MDPrincipal InvestigatorSt. Louis University

Media Library

SURGX Wound Gel Clinical Trial Eligibility Overview. Trial Name: NCT05919888 — Phase 4

Surgery Research Study Groups: SURGX Wound Gel, No skin incision preparation, Povidone-iodine

Surgery Clinical Trial 2023: SURGX Wound Gel Highlights & Side Effects. Trial Name: NCT05919888 — Phase 4

SURGX Wound Gel 2023 Treatment Timeline for Medical Study. Trial Name: NCT05919888 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who has the privilege of participating in this experiment?

"To gain admittance to this medical trial, applicants should have a surgical site infection and be between 18-90 years old. A total of 60 candidates are being recruited for the study at present."

Answered by AI

Has SURGX Wound Gel been granted authorization from the Food and Drug Administration?

"The safety of SURGX Wound Gel is rated a 3, due to the Phase 4 trial certifying its approval."

Answered by AI

Is it permissible to enroll individuals above the age of sixty in this experiment?

"This medical trial is exclusively open to individuals aged 18-90. Conversely, there are 220 studies dedicated for younger patients and 887 specifically targeting those over the age of 65."

Answered by AI

Is there an ongoing recruitment process for this trial?

"Unfortunately, clinicaltrials.gov has indicated that this particular medical study is no longer searching for volunteers. Initially posted on June 1st 2023 and most recently updated on the 16th of the same month, however there are still 1073 other trials actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Randall J. Otto, MD 2023. "SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05919888.