An interventional study of Application of fibrin glue sealant in Seroma, sponsored by Menoufia University. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-30.
Sponsored by Menoufia University · Not applicable, Interventional, and Treatment
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.
Seroma is one of the most frequent complications occurring after ILND as it affects nearly one third of these cases. During the past decades, many actions have been tried in the perioperative care to decrease the incidence of these complications, as employing well vascularized bulky flaps to obliterate the dead space and to protect vessels, great saphenous vein sparing, strict bed rest and fibrin sealant application. Realizing the underlying pathology for seroma formation is the key point in its prevention. Thirty-nine patients scheduled to perform Inguinal lymphadenectomy for various causes have been checked for eligibility to be enrolled in this prospective, randomized study. Thirty-two patients have met the inclusion criteria. Inguinal lymphadenectomy has been performed including scarifying saphenous vein. Sartorius muscle transposition flap was routinely performed for protection of femoral vessels, then an 18 French conventional non-suction tube drain was inserted in all patients. All the previous steps were similar in both groups. At this stage, the wound was closed for the control group, while fibrin glue was prepared to be applied to the fibrin glue group in a dose of 2mL for 100 cm2 surface area. Postoperatively, the daily collected drain fluid was measured till the drain was removed when the daily drainage was less than 30 ml. Then the patients were planned to be followed up postoperatively for at least 4 weeks, to detect the possible clinically encountered complications as seroma, wound infection, or skin flap necrosis.
Patients' demographic data and preexisting co-morbidities were recorded. Operative and pathological data regarding defect size, blood transfusion, primary tumor pathology, and number and status of retrieved lymph nodes were collected. The occurrence of post-operative seroma was the primary outcome. Other non serious adverse effect as hematoma, infection, or skin flap necrosis were recorded and compared between the two groups.
The normality of distribution of variables was verified by Kolmogorov- Smirnov test. Chi-square test (Fisher or Monte Carlo) was used for comparisons between groups for categorical variables. Student t-test was used to compare two groups for normally distributed quantitative variables. For not normally distributed quantitative variables, Mann Whitney test was used to compare between two groups. P value was set to be significant if \<0.05.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's enrollment of 32 is below the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →Menoufia University is the lead sponsor of 199 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A fibrin glue was applied to the lymphadenectomy bed before wound closure and insertion of a drain.
Biological: Application of fibrin glue sealant
Lymphadenctomy wound was closed after insertion of a drain,
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
Time frame: 4 weeks postpertively
| Milestone | Fibrin Glue | Control |
|---|---|---|
| Started | 16 | 16 |
| Completed | 16 | 16 |
| Not completed | 0 | 0 |
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
| participants | Fibrin Glue | Control |
|---|---|---|
| Number of Participants With Seroma Formation | 2 | 8 |
Collected over The follow up period ranged from 4 to 8 weeks with a median of 4 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fibrin Glue | 0/16 (0%) | 0/16 (0%) | 3/16 (18.8%) |
| Control | 0/16 (0%) | 0/16 (0%) | 9/16 (56.3%) |
| Event | Fibrin Glue | Control |
|---|---|---|
| InfectionInfections and infestations | 2/16 | 4/16 |
| Partial superficial skin edge necrosisSkin and subcutaneous tissue disorders | 1/16 | 3/16 |
| HematomaSurgical and medical procedures | 0/16 | 2/16 |
| Age, Categorical(Participants) | Fibrin Glue | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 14 | 28 |
| >=65 years | 2 | 2 | 4 |
| Age, Continuous(years) | Fibrin Glue | Control | Total |
|---|---|---|---|
| Mean | 56.40 ± 8.16 | 55.94 ± 8.1 | 56.19 ± 8 |
| Sex: Female, Male(Participants) | Fibrin Glue | Control | Total |
|---|---|---|---|
| Female | 4 | 6 | 10 |
| Male | 12 | 10 | 22 |
| Race (NIH/OMB)(Participants) | Fibrin Glue | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 16 | 16 | 32 |
| Region of Enrollment(Participants) | Fibrin Glue | Control | Total |
|---|---|---|---|
| Egypt | 16 | 16 | 32 |
| Inguinal lymphadenectomy(participants) | Fibrin Glue | Control | Total |
|---|---|---|---|
| Number | 16 | 16 | 32 |
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Study protocol will be available to be shared on request after study publication for 6 months.
Supporting information: Study protocol
Time frame: Six months from the time of study publication
Access criteria: Contacting the corresponding author
Ran from May 2015 to primary completion in Oct 2020, 65 months.
Results were first posted in Aug 2022, 1 year 10 months after primary completion.
Of 43 non-industry interventional studies with no phase under Seroma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's 65 months is above that.
Counting every sponsor, half of 44 studies reached it within 34 months; a quarter within 17 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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