Phase 4
N=74
Post-Operative Drainage Following Lymph Node Dissection
Malignant Melanoma · Carcinoma, Squamous Cell
Bottom Line
View on ClinicalTrials.gov: NCT00324272 ↗Enrolled (actual)
74
Serious AEs
54.1%
Results posted
Aug 2011
Primary outcome: Primary: Post-operative Wound Drainage. — 892.5; 762.5; 565; 590 ml — p=0.704
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Fibrin Sealant (Tisseel) used in the Experimental Arm. (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oxford University Hospitals NHS Trust
- Primary completion
- Dec 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Wound Drainage. |
892.5; 762.5; 565; 590 | 0.704 |
| SECONDARY Length of Hospital Inpatient Stay. |
— | — |
| SECONDARY Length of Time Drains Remain in Situ. |
7; 7.5; 7.5; 9 | 0.988 |
| SECONDARY Number of Patients With Post-operative Complications (Excluding Lymphoedema). |
12; 16; 13; 12 | 0.351 |
| SECONDARY Post Operative Pain Score Measured on 1st Post-operative Day. |
1; 2; 2; 2 | 0.002 sig |
| SECONDARY Disease Recurrence. |
11; 6; 5; 8 | 1.00 |
| SECONDARY Death. |
10; 12; 9; 9 | 0.963 |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00324272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.