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N/A N=36 Randomized Single-blind Treatment

Hydrogen Peroxide to the Wound Following Surgical Incision Affecting Cultures in Primary Shoulder Arthroplast

Primary Anatomic or Reverse Total Shoulder Arthroplasty

Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Number of Positive vs Negative Culture's Based on Skin Prep Method — 6; 6; 12; 11 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
H2O2 application to incision (Other)
Age
Adult, Older Adult · 40+ yrs
Sex
Male
Sponsor
University of Florida
Primary completion
Jul 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Positive vs Negative Culture's Based on Skin Prep Method
6; 6; 12; 11

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.

Eligibility Criteria

Inclusion Criteria

  • Male patients, age 40-90
  • Undergoing primary anatomic or reverse total shoulder arthroplasty for glenohumeral osteoarthritis or rotator cuff arthropathy

Exclusion Criteria

  • Female patients
  • Patients under 40 years or over 90 years of age
  • Diagnosis other than glenohumeral osteoarthritis or rotator cuff arthropathy
  • Prior arthroscopic or open shoulder surgery on the ipsilateral shoulder
  • Prior diagnosis of septic shoulder of the ipsilateral shoulder
  • Corticosteroid injection within 3 months of the procedure
  • Recently on antibiotics (within 2 weeks) prior to surgery
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04609306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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