Trial Outcomes & Findings for SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty (NCT NCT05919888)

NCT ID: NCT05919888

Last Updated: 2024-12-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: Day 14
• Results posted on: 2024-12-10

Participant Flow

Participants were recruited by physicians at 1 academic medical center between June 2023 and November 2023.

60 participants were enrolled, and all 60 met inclusion criteria and were randomized to a study arm.

Participant milestones

Measure	No Skin Incision Preparation 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 At the time of the surgery, after the skin incision has been made, the dermal layer will be prepped with povidone-iodine. Drug: povidone-iodine Dose: swabstick Administration: swab the incision Frequency: once Povidone-Iodine: Applied to skin incision.	SURGX Wound Gel At the time of the surgery, after the skin incision has been made, the dermal layer will 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. SURGX Wound Gel: Applied to skin incision.
Overall Study STARTED	20	20	20
Overall Study COMPLETED	20	20	20
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	No Skin Incision Preparation n=20 Participants 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 n=20 Participants At the time of the surgery, after the skin incision has been made, the dermal layer will be prepped with povidone-iodine. Drug: povidone-iodine Dose: swabstick Administration: swab the incision Frequency: once Povidone-Iodine: Applied to skin incision.	SURGX Wound Gel n=20 Participants At the time of the surgery, after the skin incision has been made, the dermal layer will 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. SURGX Wound Gel: Applied to skin incision.	Total n=60 Participants Total of all reporting groups
Age, Continuous	69.35 years STANDARD_DEVIATION 8.443 • n=5 Participants	68.50 years STANDARD_DEVIATION 10.405 • n=7 Participants	68.75 years STANDARD_DEVIATION 7.107 • n=5 Participants	68.87 years STANDARD_DEVIATION 8.615 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	39 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	21 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	20 Participants n=7 Participants	18 Participants n=5 Participants	56 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	52 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
BMI	29.1880 kg/m2 STANDARD_DEVIATION 7.22953 • n=5 Participants	32.5010 kg/m2 STANDARD_DEVIATION 5.58499 • n=7 Participants	30.7310 kg/m2 STANDARD_DEVIATION 6.53229 • n=5 Participants	30.8067 kg/m2 STANDARD_DEVIATION 6.51775 • n=4 Participants
Type of Shoulder Arthroplasty Reverse TSA	17 Participants n=5 Participants	19 Participants n=7 Participants	17 Participants n=5 Participants	53 Participants n=4 Participants
Type of Shoulder Arthroplasty Anatomic TSA	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 14

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.

Outcome measures

Measure	No Skin Incision Preparation n=20 Participants 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 n=20 Participants At the time of the surgery, after the skin incision has been made, the dermal layer will be prepped with povidone-iodine. Drug: povidone-iodine Dose: swabstick Administration: swab the incision Frequency: once Povidone-Iodine: Applied to skin incision.	SURGX Wound Gel n=20 Participants At the time of the surgery, after the skin incision has been made, the dermal layer will 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. SURGX Wound Gel: Applied to skin incision.
Presence of Bacteria Within Shoulder Culture Using Incisional Prep vs. no Prep	11 Participants	9 Participants	6 Participants

PRIMARY outcome

Timeframe: Day 14

Population: Each participant had 5 total culture swabs at end of shoulder surgery from deep (2), superficial (2), and implant (1) locations.

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.

Outcome measures

Measure	No Skin Incision Preparation n=100 culture swabs 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 n=100 culture swabs At the time of the surgery, after the skin incision has been made, the dermal layer will be prepped with povidone-iodine. Drug: povidone-iodine Dose: swabstick Administration: swab the incision Frequency: once Povidone-Iodine: Applied to skin incision.	SURGX Wound Gel n=100 culture swabs At the time of the surgery, after the skin incision has been made, the dermal layer will 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. SURGX Wound Gel: Applied to skin incision.
Presence of Bacteria Within Shoulder Culture Using Incisional Prep vs. no Prep	29 # of positive cultures	24 # of positive cultures	13 # of positive cultures

SECONDARY outcome

Timeframe: Day 14

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 baceria. The number of patients with at least one positive culture were compared among the SURGX and povidone-iodine groups.

Outcome measures

Measure	No Skin Incision Preparation n=20 Participants 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 n=20 Participants At the time of the surgery, after the skin incision has been made, the dermal layer will be prepped with povidone-iodine. Drug: povidone-iodine Dose: swabstick Administration: swab the incision Frequency: once Povidone-Iodine: Applied to skin incision.	SURGX Wound Gel n=20 Participants At the time of the surgery, after the skin incision has been made, the dermal layer will 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. SURGX Wound Gel: Applied to skin incision.
Presence of Bacteria Within Shoulder Culture Using SURGX Wound Gel Prep vs. Povidone-iodine Prep	11 Participants	9 Participants	6 Participants

Adverse Events

No Skin Incision Preparation

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Povidone-iodine

Serious events: 3 serious events

Other events: 0 other events

Deaths: 1 deaths

SURGX Wound Gel

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	No Skin Incision Preparation n=20 participants at risk 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 n=20 participants at risk At the time of the surgery, after the skin incision has been made, the dermal layer will be prepped with povidone-iodine. Drug: povidone-iodine Dose: swabstick Administration: swab the incision Frequency: once Povidone-Iodine: Applied to skin incision.	SURGX Wound Gel n=20 participants at risk At the time of the surgery, after the skin incision has been made, the dermal layer will 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. SURGX Wound Gel: Applied to skin incision.
Infections and infestations Infection	5.0% 1/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.	5.0% 1/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.	0.00% 0/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.
Cardiac disorders Atrial Fibrillation	0.00% 0/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.	0.00% 0/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.	5.0% 1/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.
Cardiac disorders Myocardial Infarction	0.00% 0/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.	5.0% 1/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.	0.00% 0/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.0% 1/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.	0.00% 0/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.	0.00% 0/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.
Musculoskeletal and connective tissue disorders Shoulder dislocation	0.00% 0/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.	5.0% 1/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.	0.00% 0/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.
Social circumstances Readmission for Social Reasons	0.00% 0/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.	0.00% 0/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.	5.0% 1/20 • 2 weeks after patient surgery through end of study Adverse events as defined by the protocol were to be collected on the date of patient's surgery and included any type of reaction to the application of product. No follow-up appointments or study procedures after date of surgery are included in this study. The events listed below were considered to be patient complications unrelated to the study, but have been included in this Results section as they meet the clinicaltrials.gov definition of AE.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Randall Otto

SSMHealth SLUCare Physician Group

Phone: 314-614-2970

Email: randall.otto@slucare.ssmhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place