Fibrin Glue in Inguinal Lymphadenectomy

NCT04666051 | Completed Results

• 1 other identifier: 4/2015/SURG
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

Seroma is one of the most common encountered morbidities after inguinal lymph node dissection (ILND). It can cause not only much nuisance to both patients and doctors but also its presence can lead to many complications. This study aimed at evaluation of the role and effect of using fibrin glue on seroma reduction in patients undergoing ILND. Thirty-two patient have undergone ILND for various causes. The patients were randomized into two groups; 16 ILND in each. In one group, fibrin glue sealant was applied with a dose of 2ml per 100 cm2 surface area then drain placement was performed. Whereas, in the control group, only drain placement was used. Preoperative, operative and postoperative data were recorded and analyzed.

Conditions

Seroma

Keywords

Fibrin glue; Seroma; Inguinal lymphadenectomy; Wound complication

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Seroma Formation

  Collection of serous fluid under the wound flaps. According to the Common Terminology Criteria for Adverse Events (CTCAE) 4.0, Grade 2 and Grade 3 were considered. Grade 2 indicates it is symptomatic; simple aspiration indicated. Grade 3 indicates it is symptomatic, elective radiologic or operative intervention indicated

  4 weeks postpertively

Study Arms (2)

Fibrin glue

EXPERIMENTAL

A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain.

Biological: Application of fibrin glue sealant

Control

NO INTERVENTION

Lymphadenctomy wound was closed after insertion of a drain,

Interventions

Application of fibrin glue sealant BIOLOGICAL

Fibrin glue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to perform ILND for various causes

You may not qualify if:

• BMI more than 35,
• Uncompensated diabetes
• Advanced liver disease
• Previous history of surgery and/or irradiation to the inguinal region
• Preoperative chemotherapy
• Significant coagulation disorders
• Platelet counts \<100,000/mL.
• Use of systemic steroids or anticoagulants.

Sponsors & Collaborators

• Menoufia University: lead

Related Publications (1)

• Buda A, Fruscio R, Pirovano C, Signorelli M, Betti M, Milani R. The use of TachoSil for the prevention of postoperative complications after groin dissection in cases of gynecologic malignancy. Int J Gynaecol Obstet. 2012 Jun;117(3):217-9. doi: 10.1016/j.ijgo.2011.12.021. Epub 2012 Mar 15.

  PMID: 22424660 BACKGROUND

MeSH Terms

Conditions

Seroma

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: M. Ashraf BAlbaa
• Organization: Menoufia Univeristy

mohamed.balbaa@med.menofia.edu.eg

+20482224216

Study Officials

• M. Ashraf Balbaa, M.D.

  Menoufia University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: May 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: August 30, 2022
• Results First Posted: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Six months from the time of study publication
• Access Criteria: Contacting the corresponding author