Does the application of cryolijm SQ fibrin sealant, for abdominal closure after secondary DIEP flap surgery, leads to a quicker recovery with less complications? A randomized controlled study.

Deep Inferior Epigastric Perforator (DIEP) Flap surgery is a surgical technique
for breast reconstruction by autologous tissue derived from the abdomen. During
closure of the abdomen 2 vacuum drains are left behind which are typically
removed after 5 to 7 days postoperatively. Occasionally, drain production takes
a longer period of time or the patient needs blood transfusions as a
consequence of prolonged drain production from the abdominal wound. Moreover,
discharge with drains in situ is often not tolerated by patients and considered
a possible risk factor for infections. As a consequence patients stay in the
hospital until all drains are removed.
This prolonged hospital admission leads to higher costs, ineffective use of
hospital beds and possibly delayed physical and psychological recovery of
patients. Literature describes the use of conventional fibrin sealant to reduce
drain production and chance of complications.

The aim of this study is to assess the efficacy of Cryolijm SQ (Sanquin blood
supply foundation, Groningen, The Netherlands) fibrin sealant in reducing
postoperative drainage at the abdominal donor site which could result in
earlier drain removal, shorter hospital admissions, fewer blood transfusions
and less post operative abdominal wound complications after DIEP flap breast
reconstructions.

In this randomized controlled study, all women who receive an autologous DIEP
flap breast reconstruction at the department of Plastic, Reconstructive and
Hand Surgery of the Erasmus MC will be eligible for this study if they meet the
proper inclusion criteria. Patients will be randomized in two groups:
conventional closure of the abdominal wound without the use of Cryolijm SQ
fibrin sealant and closure of the abdominal wound in combination with the
application of Cryolijm SQ fibrin sealant on the abdominal wound.

Cryolijm SQ (Sanquin blood supply foundation, Groningen, The Netherlands) is an
allogenic single-donor fibrin sealant produced from fresh-frozen quarantined
plasma of healthy donors.

The benefits of this project may be a decrease in abdominal donor site
complications and earlier discharge from the hospital which will result in
reduced costs and possibly in a faster physical as well as psychological
recovery.
There is no extra burden associated with participation in this study.
The procedure for each group is the same; the only difference is the
application of Cryolijm SQ in one group in addition to the standard procedure.
This product is much safer concerning anaphylactic reactions and potential
blood transmitted diseases compared to the normal used commercial products of
fibrin sealant