Skip to content

Influence of Fibrin Glue on Seroma Formation After Modified Radical Mastectomy

Influence of Fibrin Glue on Seroma Formation After Modified Radical

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00909649
Acronym
MRM
Enrollment
50
Registered
2009-05-28
Start date
2005-01-31
Completion date
2007-06-30
Last updated
2009-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

fibrin glue, seroma, mastectomy

Brief summary

This study was carried out from January 2005 to December 2007 at Mansoura university hospital. Fifty patients who had breast cancer were included in the study, MRM was done for all patients. Patients were randomly divided into two groups. Group І with fibrin glue 4ml of fibrin glue was sprayed on the surgical area with Y canula and group П without fibrin glue. Preoperative, Operative and Postoperative data were collected including postoperative measurement of drainage, date of removal of the drain, state of the wound, incidence of Seroma formation.

Detailed description

This study was carried out from January 2005 to December 2007 at Mansoura university hospital, Departement 8 of surgical department. This study approved by local ethical committee Fifty patients had breast cancer were included in the study. Patients who received preoperative chemotherapy and radiotherapy were exclude Also, patients with previous axillary surgery or patients who underwent simultaneous reconstructive surgery and breast conservative surgery and locally advanced breast cancer were exclude. Informed written consent was obtained from all patients included in the study. All patients include in the study, MRM was done for then and axillary lymphadenectomy extended to the axillary level III was done with sharp dissection and ligation of the visible lymph vessels and minor blood vessel. After performing hemostasis in the mastectomy and axillary area. .Patients were randomly divided by closed envelop into two groups. Patients were randomized at end of surgical procedure to avoid possible treatment bias during surgical procedure. Group І (with fibrin glue) and group П without fibrin glue. In fibrin glue group. 4 ml of fibrin glue was sprayed on the surgical area with Y canula (doubleject application system). In group 11 after good haemostasis the same sized drain was applied in axillary and breast area and incision was closed. Followed by external compression for 10 minutes in both groups. Drains were left in places until the drainage for the preceding 24 h was less than 30 ml/day. Data collected Preoperative data collected included age, body mass indexed (BMI), medical and surgical history, history of chemotherapy, radiotherapy Operative data included estimated blood loss, types of dissection, duration of the operation Postoperative data included hospital stay , postoperative measurement of drainage daily , date of removal , state of the wound ( infection , haematoma, necrosis , opened wound ), number of axillary lymph nodes dissected , cancer stage , number of axillary lymph nodes positive, incidence of Seroma formation , interval of Seroma resolution , Seroma aspirated volume and number of postoperative visits Seroma formation was defined as inability to remove participant drain by postoperative day 10 because of high output (more than 30 ml /day drain Seroma) and / or the need to aspirate of fluid after removal of the drain.

Interventions

PROCEDUREfibrin glue in breast surgery

fibrin glue 8 ml in the bed after modified radical mastectomy in fibrin treated group

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Patients with operable breast cancer

Exclusion criteria

* Patients who received preoperative chemotherapy and radiotherapy were exclude * Patients with previous axillary surgery * Patients who underwent simultaneous reconstructive surgery and breast conservative surgery * Locally advanced breast cancer

Design outcomes

Primary

MeasureTime frameDescription
Seroma Formationwithin 30 days postoperativethe mean total drainage volume

Countries

Egypt

Participant flow

Recruitment details

medical clinic

Participants by arm

ArmCount
Fibrin Group25
Non Fibrin Group25
Total50

Baseline characteristics

CharacteristicNon Fibrin GroupFibrin GroupTotal
Age, Categorical
<=18 years
0 Participants0 Participants0.0 Participants
Age, Categorical
>=65 years
3 Participants3 Participants6.0 Participants
Age, Categorical
Between 18 and 65 years
22 Participants22 Participants44.0 Participants
Age Continuous51.6 years
STANDARD_DEVIATION 10.8
52.2 years
STANDARD_DEVIATION 11.5
51.9 years
STANDARD_DEVIATION 10.7
Region of Enrollment
Egypt
25 participants25 participants50.0 participants
Sex: Female, Male
Female
25 Participants25 Participants50.0 Participants
Sex: Female, Male
Male
0 Participants0 Participants0.0 Participants

Outcome results

Primary

Seroma Formation

the mean total drainage volume

Time frame: within 30 days postoperative

Population: ITT

ArmMeasureValue (MEAN)Dispersion
Fibrin GroupSeroma Formation770.48 mlStandard Deviation 70.81
Non Fibrin GroupSeroma Formation1089.51 mlStandard Deviation 75.8

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026