Does Disinfection of the Subcutaneous Tissue Reduce Contamination of the Operating Field With P. Acnes?

NCT04250649 | Unknown

• 1 other identifier: 2020-00170
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Propionibacterium acnes is a pathogen commonly identified in postoperative shoulder infections. A recent study has shown that P. acnes is likely to be disseminated in the operating field from the subcutaneous layer by the manipulation of soft tissues by the surgeon and the instruments. Disinfection of the subcutaneous tissue seems to significantly reduce contamination of the operating field during primary shoulder surgery. This study seeks to assess the efficacy of disinfection of the subcutaneous tissue compared to dissection with an electrosurgical unit on P. acnes contamination during primary shoulder surgery.

Conditions

Surgical Incision

Keywords

subcutaneous desinfection, P. acnes, electric cautery

Outcome Measures

Primary Outcomes (1)

• positive sample

  Compare the positive bacteriological sample rate during an open shoulder surgery procedure with a disinfection of the subcutaneous tissue compared to an operating procedure without disinfection but dissection with an electric knife.

  4 years

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Betadine solution disinfection of the subcutaneous tissue during primary shoulder surgery

Procedure: subcutaneous tissue disinfection

Controle

NO INTERVENTION

Control group with surgery without disinfection of the subcutaneous tissue but dissection with an electric cautery during primary shoulder surgery

Interventions

subcutaneous tissue disinfection PROCEDURE

Skin and subcutaneous incision (up to the muscular fascia) with "superficial blade" scalpel, disinfection of the subcutaneous tissue with 3cc of Betadine solution, placement of the retractors, dissection and development of the delto-pectoral interval with "deep blade" scalpel. When the joint is opened, bacteriological smears are taken from 5 sites in the two groups. 1) exposed subcutaneous tissue, 2) surgeon's gloves (distal end of fingers), 3) "superficial blade", 4) "deep blade", 5) retractors. The rest of the shoulder surgery procedure does not differ from what is commonly performed. The samples are sent to bacteriology for bacterial culture. Anaerobic research is done specifically for P. acnes. The results are considered negative after 10 days.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• = or\> 18 years old
• treated at the Valais Hospital for primary shoulder surgery.
• have signed the consent

You may not qualify if:

• \<18 years old
• History of shoulder surgery
• History of shoulder infection
• Antibiotic therapy in the 2 weeks preceding the intervention
• Cortisone infiltration in the 6 months preceding the intervention
• Allergy to iodinated contrast agent or Cefuroxime
• Allergy to povidone iodine complex or other contraadication to Betadine
• Refusal of study terms

Sponsors & Collaborators

• Hôpital du Valais: lead

Study Sites (1)

Hôpital du Valais

Martigny-Ville, Valais, 1920, Switzerland

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Beat K Moor, PD Dr

  Hopital du Valais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Gallusser

CONTACT

027 603 90 00; gallussern@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: A standard block randomization strategy will be used. The ratio between intervention and control will be set at 2: 1. This will facilitate recruitment and provide more information on the effectiveness of the intervention. The randomization sequence will be created using the STATA program.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single center, category A randomized clinical trial.

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 31, 2020
• Study Start: March 31, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2024
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)