Clinical trial · Interventional
Post-Operative Drainage Following Lymph Node Dissection
Can Fibrin Sealant be Used to Reduce Post-operative Drainage Following Lymph Node Dissection: a Prospective Randomised Double Blind Trial.
NCT00324272CI-TRIAL-00005350completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the use of fibrin sealant reduces post-operative drainage following groin and axillary lymph node dissection.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Melanoma | Melanoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fibrin Sealant (Tisseel) used in the Experimental Arm. | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Groin dissection: sealant used.
- interventionNames
- Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.
- type
- ACTIVE_COMPARATOR
- label
- Groin dissection: no sealant used.
- interventionNames
- Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.
- type
- EXPERIMENTAL
- label
- Axillary dissection: sealant used.
- interventionNames
- Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm.
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years of age * Requiring groin or axillary lymph node dissection for malignant disease. Exclusion Criteria: * Patients under age 18 years. * Patients unable to speak English. * Patients with learning difficulties. * Patients with mental illness. * Prisoners. * Other vulnerable groups.
References
Publications (6)
- BACKGROUNDOliver DW, Hamilton SA, Figle AA, Wood SH, Lamberty BG. A prospective, randomized, double-blind trial of the use of fibrin sealant for face lifts. Plast Reconstr Surg. 2001 Dec;108(7):2101-5, discussion 2106-7. doi: 10.1097/00006534-200112000-00044. PMID 11743409
- BACKGROUNDMoore MM, Nguyen DH, Spotnitz WD. Fibrin sealant reduces serous drainage and allows for earlier drain removal after axillary dissection: a randomized prospective trial. Am Surg. 1997 Jan;63(1):97-102. PMID 8985079
- BACKGROUNDBerger A, Tempfer C, Hartmann B, Kornprat P, Rossmann A, Neuwirth G, Tulusan A, Kubista E. Sealing of postoperative axillary leakage after axillary lymphadenectomy using a fibrin glue coated collagen patch: a prospective randomised study. Breast Cancer Res Treat. 2001 May;67(1):9-14. doi: 10.1023/a:1010671209279. PMID 11518470
- BACKGROUNDGiovannacci L, Renggli JC, Eugster T, Stierli P, Hess P, Gurke L. Reduction of groin lymphatic complications by application of fibrin glue: preliminary results of a randomized study. Ann Vasc Surg. 2001 Mar;15(2):182-5. doi: 10.1007/s100160010049. Epub 2001 Mar 1. PMID 11265082
- BACKGROUNDJain PK, Sowdi R, Anderson AD, MacFie J. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Br J Surg. 2004 Jan;91(1):54-60. doi: 10.1002/bjs.4435. PMID 14716794
- RESULTSwan MC, Oliver DW, Cassell OC, Coleman DJ, Williams N, Morritt DG, Giele HP. Randomized controlled trial of fibrin sealant to reduce postoperative drainage following elective lymph node dissection. Br J Surg. 2011 Jul;98(7):918-24. doi: 10.1002/bjs.7462. Epub 2011 Apr 1. PMID 21456091