The Treatment of Purulent Flexor Tenosynovitis

Tenosynovitis Clinical Trial

Official title:

The Treatment of Purulent Flexor Tenosynovitis - Is Postoperative Catheter Irrigation Necessary? A Prospective Randomized Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02320929
• Other study ID #: R14153
• Status: Recruiting
• Phase: N/A
• Start date: March 2015
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Tampere University
• Contact: Olli V. Leppänen, M.D., Ph.D.
• Phone: +358-3-31167745
• Email: olli.leppanen[@]fimnet.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of postoperative intermittent closed-catheter irrigation on the recovery from the purulent flexor tenosynovitis. One group of patients suffering from acute purulent flexor tenosynovitis is treated using intraoperative irrigation only and the other group having both intra- and postoperative irrigation.

Description:

The foundation of the successful management of purulent flexor tenosynovitis is the surgical debridement followed by an intravenous antibiotic treatment. Several surgical methods have been described to remove the purulent debris from the flexor tendon sheath. Closed-catheter irrigation involves irrigation of the tendon sheath from proximal to distal direction facilitated by two small incisions; one proximal to A1 pulley and one distal to A4 pulley. Lille et al. (J Hand Surg Br. 2000;25(3):304-307) conducted a retrospective study that implied that intraoperative closed-catheter irrigation without postoperative irrigation might be as effective as the combination of intra- and postoperative irrigation. The hypothesis of this prospective randomized trial is that the intraoperative closed-catheter irrigation alone is as effective as the combination of intraoperative and postoperative intermittent closed-catheter irrigation in the treatment of purulent flexor tenosynovitis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• clinical diagnosis of purulent flexor tenosynovitis with all four positive Kanavel's

signs:

• symmetric swelling of the entire digit
• exquisite tenderness along the course of the tendon sheath
• semiflexed posture of the digit
• pain with attempted passive extension of the digit
• age over 18 years
• patient's willingness to participate in the study

Exclusion Criteria:

• High-pressure, foreign body or chemical injuries, which require open debridement
• prisoner, military serviceman, mental retardation or other factors which may affect one's decision making

Related Conditions & MeSH terms

• Tenosynovitis

Intervention

Procedure:
• Intraoperative flexor tendon sheath irrigation

• Postoperative flexor tendon sheath irrigation

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University	Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	QuickDASH score		4 weeks and 3 months postoperatively
Other	Pain at rest	Pain at rest (Visual analog scale)	4 weeks and 3 months postoperatively
Primary	Active range of movement of the most affected finger	The total active range of movement is calculated as: (active flexion of MCPJ + PIPJ + DIPJ) - (extension deficit of MCPJ + PIPJ + DIPJ). MCPJ, metacarpophalangeal joint; PIPJ, proximal interphalangeal joint; DIPJ, distal interphalangeal joint.	3 months postoperatively
Secondary	Need for reoperation		3 months postoperatively