Vacuum-Assisted Closure versus Closed Drainage using Redon Catheters for the Treatment of Mediastinitis: a Prospective Study

.Mediastinitis after cardiac surgery is a relatively frequent and serious
complication associated with high morbidity, mortality and cost. The incidence
reported in large studies is approximately 1%.
The conventional treatment of this type of mediastinitis consisted of surgical
debridement and open wound healing or reconstruction with vascularized pectoral
or omental tissue flaps. In 1997, vacuum-assisted closure was described as a
new technique for mediastinitis treatment in order to avoid secondary surgical
closure. Several studies evaluated vacuum-assisted drainage and compared the
results with conventional treatment retrospectively showing significant
improvement of the outcome after vacuum-assisted drainage. Sjogren concluded
from an analysis of 101 patients that vacuum-assisted closure resulted in
significantly lower 90-day mortality and better overall survival compared to
the conventional approach. In two more series of 42 and 68 patients, similar
perioperative mortality, shortened wound healing and hospital stay, higher
freedom from mediastinal microbiological cultures and more rapidly declining
CRP levels were reported.
In contrast, closed drainage systems like redon drainage or continuous
irrigation were proposed as alternatives for conventional treatment and
vacuum-assisted closure. Closed drainage systems aim to combine either adequate
wound drainage and faster wound healing resulting in more comfort for the
patient compared to vacuum-assisted therapy. Two retrospective studies reported
redon drainage to be superior compared to continuous irrigation. Redon drainage
resulted in less treatment failure, shorter hospital stay, lower incidence of
superinfections and lower mortality rate.
Currently, vacuum-assisted drainage and closed drainage using redon catheters
are widely accepted methods for the treatment of mediastinitis. However, it is
unknown which technique is considered to be the most effective. We hypothesize
that closed drainage using redon catheters results in faster wound healing and
earlier discharge. Therefore, we prospose a prospective randomized trial to
compare both techniques.

.Currently, vacuum-assisted drainage and closed drainage using redon catheters
are widely accepted methods for the treatment of mediastinitis. However, it is
unknown which technique is considered to be the most effective. We hypothesize
that closed drainage using redon catheters results in faster wound healing and
earlier discharge. Therefore, we prospose a prospective randomized trial to
compare both techniques.

.Design: prospective, randomized, open
Duration: for each patient 5 years
Expected inclusion period: 2.5 years (total study duration: 7.5 years): the
inclusion period is expected to start from 01-07-2007 tot 01-01-2010; the study
will finish 5 years later (01-01-2015)

Flow chart:
1. diagnosis mediastinitis according CDC* criteria: tenminste 1 van de 3
criteria is voldoende voor de diagnose mediastinitis:

(1) organism isolated from culture of mediastinal tissue or fluid obtained by
needle aspiration or during surgery OR
(2) evidence of mediastinitis seen during surgery OR evidence of mediastinitis
seen on histopathologic examination OR
(3) one or more of the following symptoms: fever (> 38° C), chest pain, or
chest instability
AND
one or more of the following: purulent drainage from
the mediastinal area, organism isolated from blood culture, organism isolated
from drainage from mediastinal area, mediastinal widening on x-ray examination

2. informed consent

3. QOL: Questionary at day 0 (before the operation), 7 and 21

4. operation: debridement and cultures

VAC group: open laten gedurende 24 uur, dan VAC plaatsen
(witte spons: rechtstreeks op het hart; zwarte spons: op andere weefsels), 125
mmHg zuigkracht
Redon groep: onmiddellijk sluiten sternum en huid, redons (dikste: 15 mm): 1
presternaal, minimaal 4 redons in alle open ruimtes/pockets

5. CRP and leucocytes: 3 x/week

6. Cultures of Redonpot (Redongroep) of wond (VAC groep): 2 x/week**

7. antibiotics: peroperatief starten na overleg microbioloog, continueren en
beeindigen na overleg microbioloog

8. postop wondzorg en behandeling alsmede beeindiging van de behandeling onder
supervisie van A. Yilmaz (533)

9. Two and five years: Phone call (survival measurement)
* Centers of Disease Control
** Aankoppelen van de Redonpotten en de wondzorg moet strikt STERIEL gebeuren

Vacuum-Assisted Closure versus Closed Drainage using Redon Catheters .

The investigation technique (closed drainage using redon catheters) will
probably result in quicker healing and discharge.