A comparison between high and low pressure continuous closed suction drainage systems - A prospective intra-individual randomized controlled study of drainage management after chest wall masculinization in female-to-male transgenders

Breast surgery is a major domain of plastic surgery practice and comprises
procedures of amputation, reduction, augmentation and reconstruction. Main
complications of breast surgery include development of hematoma or seroma,
infection and wound healing problems. Other technique-specific complications
are nipple-areola necrosis (breast reduction), implant rupture & capsular
contraction (reconstruction or augmentation), or flap failure (Stojkovic et
al., 2013).

Drain insertion is usually the final step of surgical breast procedures, and
serves a multi-purpose role; (1) preventing fluid collection, (2) eliminating
the dead space, and (3) approximating tissue to foster adequate wound healing.
Surgical drains can be subdivided into open and closed (or intermittent vs.
continuous) systems, with passive or active suction. Other characteristics
include the strength of negative pressure applied and aspect of drain tubes
(Stojkovic et al., 2013).

Although surgical drain use is associated with the previously mentioned
clinical advantages, conflicting findings have been published on the type of
drains to be used preferentially. Reported drain related complications include
persisting hematoma and fluid production, and drain-specific complications
(Stojkovic et al., 2013; Kosins et al., 2013). Some of these complications are
thought to be the result of the strength of negative pressure applied. Given
this ambiguous evidence of clinical effectiveness and burden of post-operative
complications, prospective studies of optimal drain use are inevitable. In this
study we will specifically compare the efficacy of a continuous low pressure
drain system with a high pressure drain system.

Aim of the study is to compare the efficacy and safety of the use of a low
vacuum constant drainage system (Palin®) with a high vacuum closed suction
drainage system (Medinorm S-400®) after chest wall masculinization in
female-to-male transgenders.

The study is a prospective, single blinded, intra-patient randomized controlled
study, which will be performed in a single center setting (Jan van Goyen
clinic, Amsterdam). The enrolment period is 9 months to 1 year and the
follow-up period is maximally 4-8 weeks. Patient*s time commitment for the
study is maximally 14 weeks (including pre-operative assessment).

All study subjects will receive the most suitable surgical technique of chest
wall masculinization based on breast tissue volume and ptosis, and skin
elasticity and surplus (Cregten-Escobar et al., 2012; Monstrey et al., 2008).
At the end of the surgery the specialist will leave one high and one low vacuum
continuous closed suction drainage system in situ according to pre-operative
randomization:

group 1: high pressure system left hemithorax & low pressure system right
hemithorax
group 2: low pressure system left hemithorax & high pressure system right
hemithorax

The drain tube, type fluted (Palin®) or middle perforated (Medinorm S-400®),
will be inserted in the surgical space my means of the trocar. The drain tube
will be inserted halfway of the predefined range, as advised by the
manufacturers and will be attached to the patients skin by means of
non-absorbable sutures.

Drains will be left in the wound based on fluid production and will be removed
either before discharge (in case of low/moderate postoperative production) or
after discharge (in case of high postoperative production). When drain
production drops after discharge, patients will contact the investigator to
plan drain removal at the outpatient clinic of VU university medical center.

Recruited patients will be treated according to normal standards of care. There
is no direct benefit of the study to the patients included in the study.
However, the study will objectively assess the results and complications of two
drain systems and thus provide evidence to assess whether there are differences
between these options. This information will benefit future patients who will
undergo these procedures. The extra burden for the patient includes the
completion ultrasound and extra questions on pain, satisfaction and functioning
during outpatient clinic visits. The risks involved are expected to be
equivalent to the risk of the standard procedures.

- asymmetry of post-operative results: impact: low, likelihood: low;
- moderate complications (e.g. infection, small haematoma): impact: moderate,
likelihood: no added risk;
- severe complications (e.g. 2nd surgery, major abscess): impact: severe,
likelihood: no added risk.