Trial Outcomes & Findings for Fibrin Glue in Inguinal Lymphadenectomy (NCT NCT04666051)
NCT ID: NCT04666051
Last Updated: 2022-08-30
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
4 weeks postpertively
Results posted on
2022-08-30
Participant Flow
Participant milestones
| Measure |
Fibrin Glue
A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain.
Application of fibrin glue sealant
|
Control
Lymphadenctomy wound was closed after insertion of a drain,
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fibrin Glue in Inguinal Lymphadenectomy
Baseline characteristics by cohort
| Measure |
Fibrin Glue
n=16 Participants
A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain.
Application of fibrin glue sealant
|
Control
n=16 Participants
Lymphadenctomy wound was closed after insertion of a drain,
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
56.40 years
STANDARD_DEVIATION 8.16 • n=5 Participants
|
55.94 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
56.19 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Inguinal lymphadenectomy
|
16 participants
n=5 Participants
|
16 participants
n=7 Participants
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks postpertivelyPopulation: Serum formation has been looked for
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
Outcome measures
| Measure |
Fibrin Glue
n=16 Participants
A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain.
Application of fibrin glue sealant
|
Control
n=16 Participants
Lymphadenctomy wound was closed after insertion of a drain,
|
|---|---|---|
|
Number of Participants With Seroma Formation
|
2 participants
|
8 participants
|
Adverse Events
Fibrin Glue
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fibrin Glue
n=16 participants at risk
A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain.
Application of fibrin glue sealant
|
Control
n=16 participants at risk
Lymphadenctomy wound was closed after insertion of a drain,
|
|---|---|---|
|
Surgical and medical procedures
Hematoma
|
0.00%
0/16 • The follow up period ranged from 4 to 8 weeks with a median of 4 weeks.
Hematoma, infection and partial superficial skin edge necrosis have been recorded as adverse effects that are categorized as "Other" adverse effects as per clinical trails.gov definitions,
|
12.5%
2/16 • Number of events 2 • The follow up period ranged from 4 to 8 weeks with a median of 4 weeks.
Hematoma, infection and partial superficial skin edge necrosis have been recorded as adverse effects that are categorized as "Other" adverse effects as per clinical trails.gov definitions,
|
|
Infections and infestations
Infection
|
12.5%
2/16 • Number of events 2 • The follow up period ranged from 4 to 8 weeks with a median of 4 weeks.
Hematoma, infection and partial superficial skin edge necrosis have been recorded as adverse effects that are categorized as "Other" adverse effects as per clinical trails.gov definitions,
|
25.0%
4/16 • Number of events 4 • The follow up period ranged from 4 to 8 weeks with a median of 4 weeks.
Hematoma, infection and partial superficial skin edge necrosis have been recorded as adverse effects that are categorized as "Other" adverse effects as per clinical trails.gov definitions,
|
|
Skin and subcutaneous tissue disorders
Partial superficial skin edge necrosis
|
6.2%
1/16 • Number of events 1 • The follow up period ranged from 4 to 8 weeks with a median of 4 weeks.
Hematoma, infection and partial superficial skin edge necrosis have been recorded as adverse effects that are categorized as "Other" adverse effects as per clinical trails.gov definitions,
|
18.8%
3/16 • Number of events 3 • The follow up period ranged from 4 to 8 weeks with a median of 4 weeks.
Hematoma, infection and partial superficial skin edge necrosis have been recorded as adverse effects that are categorized as "Other" adverse effects as per clinical trails.gov definitions,
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place