Trial Outcomes & Findings for Hydrogen Peroxide to the Wound Following Surgical Incision Affecting Cultures in Primary Shoulder Arthroplast (NCT NCT04609306)

Last Updated: 2024-07-22

Results Overview

Following our standard protocols for skin preparation (which includes an application of 3% H2O2, alcohol, and then Chloraprep in sequence) and draping (with Ioban applied over the skin), we will start the procedure as normal. The skin incision will be made in standard fashion, and the knife used will be removed from the surgical field. For the experimental cohort, a lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes. Following the 3 minutes, the sponge will be removed, the wound will be flushed with 100 mL of normal saline, and the exposed dermis will be swabbed and sent for culture. In the control cohort, the dermis will be swabbed and sent for culture immediately after the skin incision is made and the knife is removed from the field.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

3 minutes prior to surgery

Results posted on

2024-07-22

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects Getting 3% H2O2 Applied to the Incision For the experimental cohort, a lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes. Following the 3 minutes, the sponge will be removed, the wound will be flushed with 100 mL of normal saline, and the exposed dermis will be swabbed and sent for culture. H2O2 application to incision: A lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes.	Subjects Not Getting 3% H2O2 Applied to the Incision In the control cohort, the dermis will be swabbed and sent for culture immediately after the skin incision is made and the knife is removed from the field.
Overall Study STARTED	18	18
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Getting 3% H2O2 Applied to the Incision n=18 Participants For the experimental cohort, a lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes. Following the 3 minutes, the sponge will be removed, the wound will be flushed with 100 mL of normal saline, and the exposed dermis will be swabbed and sent for culture. H2O2 application to incision: A lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes.	Subjects Not Getting 3% H2O2 Applied to the Incision n=17 Participants In the control cohort, the dermis will be swabbed and sent for culture immediately after the skin incision is made and the knife is removed from the field.	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=18 Participants	6 Participants n=17 Participants	13 Participants n=35 Participants
Age, Categorical >=65 years	11 Participants n=18 Participants	11 Participants n=17 Participants	22 Participants n=35 Participants
Age, Continuous	67.8 years n=18 Participants	71.8 years n=17 Participants	69.8 years n=35 Participants
Sex: Female, Male Female	0 Participants n=18 Participants	0 Participants n=17 Participants	0 Participants n=35 Participants
Sex: Female, Male Male	18 Participants n=18 Participants	17 Participants n=17 Participants	35 Participants n=35 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	18 participants n=18 Participants	18 participants n=17 Participants	36 participants n=35 Participants

PRIMARY outcome

Timeframe: 3 minutes prior to surgery

Outcome measures

Outcome measures
Measure	Subjects Getting 3% H2O2 Applied to the Incision n=18 Participants For the experimental cohort, a lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes. Following the 3 minutes, the sponge will be removed, the wound will be flushed with 100 mL of normal saline, and the exposed dermis will be swabbed and sent for culture. H2O2 application to incision: A lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes.	Subjects Not Getting 3% H2O2 Applied to the Incision n=17 Participants In the control cohort, the dermis will be swabbed and sent for culture immediately after the skin incision is made and the knife is removed from the field.
Number of Positive vs Negative Culture's Based on Skin Prep Method Number of positve cultures	6 Participants	6 Participants
Number of Positive vs Negative Culture's Based on Skin Prep Method Number of negative cultures	12 Participants	11 Participants

Adverse Events

Subjects Getting 3% H2O2 Applied to the Incision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subjects Not Getting 3% H2O2 Applied to the Incision

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Wright, MD

University of Orthopaedics

Phone: (352) 273-7001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place