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A Prospective Randomized Comparative Study of Preoperative Skin Preparation and Antiseptic Agents in Arthroscopic Shoulder Surgery

A Prospective Randomized Comparative Study of Preoperative Skin Preparation and Antiseptic Agents in Arthroscopic Shoulder Surgery - SPARC study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060219
Enrollment
200
Registered
2026-01-01
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rotator cuff tear and recurrent shoudler dislocation

Interventions

Standard preoperative skin disinfection using an alcohol-based chlorhexidine solution performed immediately before surgery. Benzoyl peroxide is applied to the surgical site twice daily on the second

Sponsors

Funabashi Orthopaedic Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients scheduled to undergo arthroscopic rotator cuff repair for a rotator cuff tear or arthroscopic Bankart repair for recurrent shoulder instability at our institution 2. Patients who received an explanation of the study and provided written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with a known allergy or hypersensitivity to any study agent 2. Patients with active skin disorders at the surgical site 3. Patients who had received systemic antibiotics or applied a topical antimicrobial agent to the operative shoulder within 2 weeks before enrollment 4. Patients with a history of previous surgery on the affected shoulder 5. Patients for whom the use of an adhesive incise drape at the operative site was planned

Design outcomes

Primary

MeasureTime frame
Culture positivity rate of Cutibacterium acnes in skin specimens collected at the end of surgery

Secondary

MeasureTime frame
Culture positivity rate of Cutibacterium acnes in skin specimens collected before surgery and immediately after skin disinfection Semi-quantitative culture results of Cutibacterium acnes in skin specimens collected before surgery, immediately after skin disinfection, and at the end of surgery Incidence of skin-related adverse events associated with preoperative skin preparation Compliance with preoperative skin preparation using benzoyl peroxide

Countries

Japan

Contacts

Public ContactHideki Kamijo

Funabashi Orthopaedic Hospital Sports Medicine & Joint Center

hideki_kamijou@yahoo.co.jp047-425-5585

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026