The Treatment of Purulent Flexor Tenosynovitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tenosynovitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intraoperative irrigation only

The infected tendon sheath is irrigated intraoperatively, the catheter is removed, and small rubber srains are left in small incisions.

Group Type EXPERIMENTAL

Intraoperative flexor tendon sheath irrigation

Intervention Type PROCEDURE

Intra- and postoperative irrigation

The infected tendon sheath is irrigated intraoperatively, the catheter is kept in place, the irrigation is continued postoperatively 3 times a day for 3 days.

Group Type ACTIVE_COMPARATOR

Intraoperative flexor tendon sheath irrigation

Intervention Type PROCEDURE

Postoperative flexor tendon sheath irrigation

Intervention Type PROCEDURE

Interventions

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Intraoperative flexor tendon sheath irrigation

Intervention Type PROCEDURE

Postoperative flexor tendon sheath irrigation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No