Analysis of coagulation factor XIII as a predictor of postoperative complications after reconstructive surgery in patients following massive weight loss.

Recruiting

Conditions: L98.7
Excessive and redundant skin and subcutaneous tissue

Registration Number: DRKS00032149

Lead Sponsor: Marien Hospital Witten

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 168

Inclusion Criteria

Initially, all patients should have had a body mass index (BMI) of = 40 kg/m² and currently have a BMI below 35 kg/m² for the planned surgery.

Patients in the control group
Upper extremity fracture (excluding carpus or hand fractures) and a stable BMI of < 35 kg/m² in the past 12 months (no changes of 5% or more in body weight). In differentiation from the first group, these must not have had a BMI of = 40 kg/m² in the past.

Exclusion Criteria

- Patients during pregnancy and lactation
- Hypersensitivity to the active substance factor XIII
- Hypersensitivity to heparin
- Known coagulation disorder
- Current anticoagulation
- Termination of anticoagulation less than 6 months ago

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measurement of factor XIII activity (%) at the following time points:<br>- Pre-operative<br>- 2 days postoperatively<br>- 5 days postoperatively<br><br>For this laboratory analysis, a total collection of one citrate tube (3.0 ml) of whole blood is required at all three time points. Factor XIII activity is determined by the BCS XP system (Siemens Healthcare GmbH, Erlangen, Germany) using the assay Berichrom® Factor XIII (Siemens Healthcare).

Secondary Outcome Measures

Name	Time	Method
In the course of the post-operative and post-inpatient follow-up of patients, the occurrence of major (i. e. indication for surgical revision due to a wound healing disorder, a hematoma or seroma, and puncture of a hematoma or seroma; %) and minor complications (i. e. conservative wound management to promote healing of corresponding wounds, no indication for surgical revision of a hematoma or seroma; %) is recorded in the documentation form.