CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
H2O2 application to incisionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04609306
NCT04609306N/ACompleted

How Does Hydrogen Peroxide Application to the Wound Following Surgical Incision Affect C. Acnes Cultures in Primary Shoulder Arthroplasty?

University of Florida·interventional·Posted Oct 30, 2020·Updated Jul 22, 2024

In Brief

A clinical study evaluating H2O2 application to incision for Primary Anatomic or Reverse Total Shoulder Arthroplasty. Completed, enrolled 36 participants across 1 site.

Detailed Summary

Cutibacterium acnes has been the focus of much recent shoulder literature, as it has been found to be both a common cause of periprosthetic joint infection as well as a common contaminant in shoulder surgery. Standard skin preparations have been found to be ineffective at eradicating C. acnes colonization on the skin and deep dermis of patients undergoing surgery. Recent literature has shown that skin preparation with 3% hydrogen peroxide solution is effective for decreasing the rate of cultures positive for C. acnes in both dermal and deep cultures; however, a positive rate of 10%-17% has still been reported despite this skin preparations. The current theory is that standard skin preparation does not remove C. acnes from the deep dermis which subsequently contaminates the deep tissue. We hypothesize that application of 3% hydrogen peroxide to the deep dermal layer immediately following the skin incision will even further decrease the rate of C. acnes contamination during surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedOct 30, 2020
Enrollment StartJan 26, 2021
Primary CompletionJul 7, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.7 years ago

Interventions

H2O2 application to incisionother

A lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes.