Malignant MelanomaPhase 4NCT00324272
Post-Operative Drainage Following Lymph Node Dissection
A Phase 4 study testing Fibrin Sealant (Tisseel) used in the Experimental Arm. in people with Malignant Melanoma and Carcinoma, Squamous Cell, run by Oxford University Hospitals NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma, Carcinoma, Squamous Cell
- What is being tested?
- Fibrin Sealant (Tisseel) used in the Experimental Arm.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Jan 2003to Jun 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Requiring groin or axillary lymph node dissection for malignant disease.
Who cannot join
- Patients under age 18 years.
- Patients unable to speak English.
- Patients with learning difficulties.
- Patients with mental illness.
- Prisoners.
- Other vulnerable groups.
About this study
Official title: Can Fibrin Sealant be Used to Reduce Post-operative Drainage Following Lymph Node Dissection: a Prospective Randomised Double Blind Trial.
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.
Read the detailed description
Background: Fibrin sealant has been used for many years in clinical practice and has a wide range of applications including the control of lymphatic leaks and haemostasis. The physiological mechanism of action of fibrin was first described by Morawitz in 1905; fibrin sealant was first marketed in 1983.
Lymph node dissection is undertaken for the control of malignant disease - frequently malignant melanoma or squamous cell carcinoma. Following groin or axillary dissection, excessive post operative drainage may necessitate the presence of wound drains for 10 days or more. This may prolong hospital stay in some patients, and may be associated with an increased complication rate (such as wound infection).
Hypothesis: the use of fibrin sealant prior to wound closure following either groin or axillary dissection may reduce post-operative wound drainage.
Comparison: patients who require an elective groin or axillary dissection who either undergo standard wound closure or those who have fibrin sealant instilled into the surgical wound prior to wound closure.
- Conditions
- Malignant Melanoma, Carcinoma, Squamous Cell
- Being tested
- Fibrin Sealant (Tisseel) used in the Experimental Arm.
- Keywords
- Groin dissection, Axilla (or axillary) dissection, Lymph node dissection, Lymphadenectomy, Seroma, Wound drainage, Fibrin sealant, Malignant melanoma, Squamous cell carcinoma
- Medical subject headings
- Melanoma, Carcinoma, Squamous Cell, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin Sealant (Tisseel) used in the Experimental Arm.Drug
For patients in the Experimental (Treatment) Arm, 4 ml of Tisseel fibrin sealant were instilled into the wound using the Duploject™ spray delivery system prior to wound closure. Tisseel™ fibrin sealant was provided by Baxter Healthcare Ltd., Newbury, Berkshire, UK.
For patients in the Active Comparator (Control) Arm, no fibrin sealant was used during wound closure (with the surgical procedure being identical in all other respects).
| Study group | Role | What they receive |
|---|---|---|
| Groin dissection: sealant used. | Experimental | Not described Receives: Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm. |
| Groin dissection: no sealant used. | Active comparator | Not described Receives: Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm. |
| Axillary dissection: sealant used. | Experimental | Not described Receives: Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm. |
| Axillary dissection: no sealant used. | Active comparator | Not described Receives: Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Wound Drainage.
The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain.
Measured: From date of surgery to date of wound drain removal (typically a period of approximately one week).
Secondary outcomes (6)
Length of Hospital Inpatient Stay.
The length of hospital stay was calculated from the day of surgery to the day that the patient was discharged from hospital.
Measured: From date of surgery until date of discharge from hospital.
Length of Time Drains Remain in Situ.
The duration of postoperative wound drainage was measured from the day of surgery until the the date of removal of the last wound drain.
Measured: From date of surgery until date of wound drain removal.
Number of Patients With Post-operative Complications (Excluding Lymphoedema).
Complications were classified as being either 'Minor' (i.e. (managed without operation, prolonged hospital stay or readmission) or 'Major' (i.e. requiring surgical intervention or readmission to hospital). The number of patients with each 'Minor' and 'Major' complication were recorded.
Measured: Until wound healing complete.
Post Operative Pain Score Measured on 1st Post-operative Day.
Pain score was recorded at 24 hours following the completion of surgery using a Visual Analogue Score (using a scale of 1 [no pain] to 10 [very severe pain]) which the patient was asked to record.
Measured: During the immediate post-operative period.
Disease Recurrence.
This was measured as either: 1. the number of participants with local recurrence; 2. the number of participants with in transit or regional recurrence; or 3. the number of participants with distant metastasis (but alive on 1st June 2010).
Measured: From date of surgery until end of study follow-up period (1st June 2010)
Death.
Death was recorded as the number of participants who had died by the end of the study follow-up period (1st June 2010). Deaths were recorded as either being related to the primary disease (i.e. due to distant metastasis) or death due to another (unrelated) cause (e.g. myocardial infarction or cerebrovascular accident).
Measured: From day of surgery until end of study follow-up period (1st June 2010)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2006 (estimated)
- Study startJan 2003
- Primary completionDec 2006
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Investigators
- Henk P. Giele, MBBS FRACS, Principal investigator, UK: National Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324272
- Sponsor's protocol ID
- C02.240
- Status last verified
- May 2006
- First submitted
- 8 May 2006
- Last updated
- 11 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Oliver 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.
PubMed 11743409Moore 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.
PubMed 8985079Berger 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.
PubMed 11518470Giovannacci 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.
PubMed 11265082Jain 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.
PubMed 14716794Swan 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.
PubMed 21456091
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Fibrin Sealant be Used to Reduce Post-operative Drainage Following Lymph Node Dissection: a Prospective Randomised Double Blind Trial.
- ClinicalTrials.gov ID
- NCT00324272
- Acronym / sponsor ID
- C02.240
- Conditions
- Malignant Melanoma, Carcinoma, Squamous Cell
- Keywords
- Groin dissection, Axilla (or axillary) dissection, Lymph node dissection, Lymphadenectomy, Seroma, Wound drainage, Fibrin sealant, Malignant melanoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jan 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 May 2006 (estimated)
- Results
- Posted 11 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Fibrin sealant has been used for many years in clinical practice and has a wide range of applications including the control of lymphatic leaks and haemostasis. The physiological mechanism of action of fibrin was first described by Morawitz in 1905; fibrin sealant was first marketed in 1983.
Lymph node dissection is undertaken for the control of malignant disease - frequently malignant melanoma or squamous cell carcinoma. Following groin or axillary dissection, excessive post operative drainage may necessitate the presence of wound drains for 10 days or more. This may prolong hospital stay in some patients, and may be associated with an increased complication rate (such as wound infection).
Hypothesis: the use of fibrin sealant prior to wound closure following either groin or axillary dissection may reduce post-operative wound drainage.
Comparison: patients who require an elective groin or axillary dissection who either undergo standard wound closure or those who have fibrin sealant instilled into the surgical wound prior to wound closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Groin dissection: sealant used. | Experimental | Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm. |
| Groin dissection: no sealant used. | Active comparator | Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm. |
| Axillary dissection: sealant used. | Experimental | Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm. |
| Axillary dissection: no sealant used. | Active comparator | Drug: Fibrin Sealant (Tisseel) used in the Experimental Arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- Requiring groin or axillary lymph node dissection for malignant disease.
Key exclusion criteria (6 listed)
- Patients under age 18 years.
- Patients unable to speak English.
- Patients with learning difficulties.
- Patients with mental illness.
- Prisoners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrin Sealant (Tisseel) used in the Experimental Arm.For patients in the Experimental (Treatment) Arm, 4 ml of Tisseel fibrin sealant were instilled into the wound using the Duploject™ spray delivery system prior to wound closure. Tisseel™ fibrin sealant was provided by Baxter Healthcare Ltd., Newbury, Berkshire, UK. For patients in the Active Comparator (Control) Arm, no fibrin sealant was used during wound closure (with the surgical procedure being identical in all other respects). | Drug | Axillary dissection: no sealant used., Axillary dissection: sealant used., Groin dissection: no sealant used., Groin dissection: sealant used. |
Primary outcome
Post-operative Wound Drainage.
Time frame: From date of surgery to date of wound drain removal (typically a period of approximately one week).
The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain.
6 secondary outcomes
Length of Hospital Inpatient Stay.
Time frame: From date of surgery until date of discharge from hospital.
Length of Time Drains Remain in Situ.
Time frame: From date of surgery until date of wound drain removal.
Number of Patients With Post-operative Complications (Excluding Lymphoedema).
Time frame: Until wound healing complete.
Post Operative Pain Score Measured on 1st Post-operative Day.
Time frame: During the immediate post-operative period.
Disease Recurrence.
Time frame: From date of surgery until end of study follow-up period (1st June 2010)
Death.
Time frame: From day of surgery until end of study follow-up period (1st June 2010)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11743409Oliver 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.
- Background: PubMed 8985079Moore 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.
- Background: PubMed 11518470Berger 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.
- Background: PubMed 11265082Giovannacci 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.
- Background: PubMed 14716794Jain 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.
- Results publication: PubMed 21456091Swan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henk P. Giele, MBBS FRACS principal investigator
UK: National Health Service
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fibrin Sealant (Tisseel) used in the Experimental Arm. in people with Malignant Melanoma and Carcinoma, Squamous Cell, run by Oxford University Hospitals NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Wound Drainage. (time frame: From date of surgery to date of wound drain removal (typically a period of approximately one week).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00324272, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.