HypotensionPhase 3NCT00420277
Phase III Study of Hemospan® for Treating Hypotension in Hip Arthroplasty
A Phase 3 study testing Hemospan (MP4OX) and Voluven (HES 130/0.4) in people with Hypotension and Ischemia, run by Sangart at 22 sites in 5 countries.
Trial summary
The purpose of this study is to determine whether Hemospan is superior to Voluven for treatment of hypotensive episodes during the perioperative period (from induction of spinal anesthesia until 6 hours after skin closure), and for reducing the incidence of operative and postoperative complications including organ… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hypotension, Ischemia
- What is being tested?
- Hemospan (MP4OX) and Voluven (HES 130/0.4)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- 22 sitesin 5 countries
- Study dates
- Feb 2007to Apr 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo elective primary hip arthroplasty (based on an osteoarthritis diagnosis) under spinal anesthesia
- Adult male or female (surgically sterile or post-menopausal), aged 50 years or older
- American Society of Anesthesiology (ASA) Class II or III
- Physical examination, laboratory status, vital signs, and ECG within acceptable limits for the planned surgery, as judged by the investigator
- Have been given written and verbal information by the investigator about Hemospan and the protocol, and have had the opportunity to ask questions about the study
- Patients must sign an Informed Consent form that has been reviewed and approved by the independent Ethics Committee
Who cannot join
- Hip fracture patients and nail/pin extraction procedures
- Clinical evidence of uncontrolled cardiovascular, infectious, psychiatric, metabolic or systemic disorders including diabetes and rheumatoid arthritis
- Evidence of significant hypertension with SBP >180 mmHg, or a difference in SBP obtained in each arm that is >15 mmHg (measured in the supine position in both arms, at screening)
- Recent history or evidence of MI or stroke (within 6 months)
- Known alcohol or drug dependency
- Currently taking oral anti-coagulant therapy; except for low-dose aspirin (acetylsalicylic acid), <200 mg/day
Show all 9Show fewer
- History of coagulopathy
- Involved in any investigational drug or device trial within 30 days prior to this study
- Professional or ancillary personnel involved with this study
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
Sweden6 sites
Länssjukhuset Gävle
Gävle
Kalmar Hospital
Kalmar
Lasarettet Motala
Motala
Danderyd Sjukhus
Stockholm
Söder Hospital
Stockholm
Uddevalla Sjukhus
Uddevalla
Poland5 sites
Samodzielny Publiczny Szpital Kliniczny AM
Bialystok
SP Wojewódzki Szpital Chirurgii Urazowej
Piekary Śląskie
Wojewódzki Szpital Specjalistyczny nr 5
Sosnowiec
Instytut Reumatologii, Klinika Reumoortopedii
Warsaw
SK Dzieciątka Jezus
Warsaw
Czechia4 sites
Fakultni nemocnice Hradec Kralove
Hradec Králové
Fakultni nemocnice Motol, I. Ortopedicka klinika
Prague
Fakultni nemocnice Motol, II. Ortopedicka klinika
Prague
Fakultni nemocnice Na Bulovce
Prague
Netherlands4 sites
Medisch Spectrum Twente
Enschede
Tergooi Ziekenhuizen, locatie Hilversum
Hilversum
Sint Maartenskliniek
Nijmegen
UMC Erasmus
Rotterdam
Belgium3 sites
CHU Brugmann
Brussels
Z.O.L. Genk
Genk
Stedelijk Ziekenhuis Roeselare
Roeselare
About this study
Official title: A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of an Oxygen-Carrying Plasma Expander, Hemospan®, Compared With Voluven® toTreat Hypotension in Patients Undergoing Primary Hip Arthroplasty With Spinal Anesthesia
The purpose of this study is to determine whether Hemospan is superior to Voluven for treatment of hypotensive episodes during the perioperative period (from induction of spinal anesthesia until 6 hours after skin closure), and for reducing the incidence of operative and postoperative complications including organ dysfunction and failure until follow-up at one month following surgery. An independent Data Safety Monitoring Board (DSMB) will periodically evaluate the safety data collected during this trial
Read the detailed description
Hemospan is a novel hemoglobin-based oxygen carrier developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia. As a result of its molecular size and oxygen binding characteristics, Hemospan selectively off-loads oxygen in tissues predisposed to low oxygen tension. Preclinical evidence suggests that Hemospan provides rapid and effective plasma expansion and tissue perfusion, and that the properties of Hemospan target oxygen release in the microcirculation.
Spinal anesthesia is the preferred choice for hip arthroplasty procedures in elderly patients, but is associated with a functional hypovolemia due to loss of vascular tone that frequently causes acute hypotensive episodes. Hypotension represents a surrogate marker of hypovolemia that may be further exacerbated by surgical bleeding, which can result in decreased cardiac output, insufficient perfusion and inadequate tissue oxygenation. Ischemia resulting from hypotension can adversely affect vital organ function and may result in complications and postoperative morbidity. As the population ages and more patients become candidates for orthopedic reconstruction or joint replacement surgery, the number of patients at risk is increasing. The ideal IV solution for treating hypovolemia-associated hypotension and improving hemodynamic stability would be an effective plasma expander that promotes tissue perfusion and delivers oxygen to ischemic or marginally hypoxic tissue.
Preclinical animal studies have shown that Hemospan may be well-suited to this application and may even be better than blood in some situations. Data from Sangart's Phase II orthopedic surgery study (No. 6055), published recently by Olofsson et al. (Anesthesiology 2006; 105(6):1153-63) support the safety and potential benefit of Hemospan for preventing and treating hypotension in orthopedic surgery patients undergoing hip replacement surgery under spinal anesthesia.
- Conditions
- Hypotension, Ischemia
- Being tested
- Hemospan (MP4OX), Voluven (HES 130/0.4)
- Keywords
- Hip arthroplasty, Anesthesia, spinal, Hypotension, Ischemia, Blood substitutes, Plasma expanders
- Medical subject headings
- Hypotension, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemospan (MP4OX)Drug
Also called MP4OX solution, 4.3 g/dL MalPEG-Hb, PEGylated Hb
250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers
Voluven (HES 130/0.4)Drug
Also called 6% HES 130/0.4, 6% hetastarch solution, Voluven
250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers
| Study group | Role | What they receive |
|---|---|---|
| Hemospan (MP4OX) | Experimental | 4.3 g/dL MalPEG-Hb solution Receives: Drug: Hemospan (MP4OX) |
| Control | Active comparator | Voluven (HES 130/0.4) Receives: Drug: Voluven (HES 130/0.4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total duration of all hypotensive episodes occurring during anesthesia/surgery and throughout the postoperative period (defined as the first 6 hours following skin closure)
Measured: Up to 6 hours after skin closure
Secondary outcomes (10)
Incidence of serious operative and postoperative complications, combined into a Composite Morbidity Outcome that includes acute heart failure, acute MI, ischemic stroke, and renal failure
Measured: 30 days
Incidence of operative and postoperative organ dysfunction related to ischemia and/or tissue hypoxia, as a Composite Ischemia Outcome that includes clinical evidence of cerebral ischemia, myocardial ischemia, and renal dysfunction
Measured: 30 days
Mortality (In-hospital, and all-cause at 30 days)
Measured: 30 days
Time to resolve/correct the initial hypotensive episode that led to the first dosing trigger
Measured: Intraoperative
Time to the second dosing trigger from the first dosing trigger
Measured: Intraoperative
Proportion of patients treated successfully with one dose
Measured: Intraoperative
Incidence of hypotension
Measured: Up to 6 hours after skin closure
Duration of the longest period of hypotension recorded
Measured: Up to 6 hours after skin closure
Incidence of intervention with a pressor agent to treat hypotensive episodes
Measured: Up to 6 hours after skin closure
Incidence of postoperative intervention with a diuretic for volume-overload or inadequate urine output
Measured: Post-operative day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startFeb 2007
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sangart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe van der Linden, MD, PhD, Principal investigator, CHU Brugmann, Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420277
- Sponsor's protocol ID
- 6090
- Status last verified
- Aug 2013
- First submitted
- 9 Jan 2007
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bjorkholm M, Fagrell B, Przybelski R, Winslow N, Young M, Winslow RM. A phase I single blind clinical trial of a new oxygen transport agent (MP4), human hemoglobin modified with maleimide-activated polyethylene glycol. Haematologica. 2005 Apr;90(4):505-15.
PubMed 15820947Cabrales P, Tsai AG, Winslow RM, Intaglietta M. Effects of extreme hemodilution with hemoglobin-based O2 carriers on microvascular pressure. Am J Physiol Heart Circ Physiol. 2005 May;288(5):H2146-53. doi: 10.1152/ajpheart.00749.2004. Epub 2005 Jan 6.
PubMed 15637119Young MA, Riddez L, Kjellstrom BT, Bursell J, Winslow F, Lohman J, Winslow RM. MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Crit Care Med. 2005 Aug;33(8):1794-804. doi: 10.1097/01.ccm.0000172648.55309.13.
PubMed 16096458Tsai AG, Cabrales P, Manjula BN, Acharya SA, Winslow RM, Intaglietta M. Dissociation of local nitric oxide concentration and vasoconstriction in the presence of cell-free hemoglobin oxygen carriers. Blood. 2006 Nov 15;108(10):3603-10. doi: 10.1182/blood-2006-02-005272. Epub 2006 Jul 20.
PubMed 16857991Winslow RM. Current status of oxygen carriers ('blood substitutes'): 2006. Vox Sang. 2006 Aug;91(2):102-10. doi: 10.1111/j.1423-0410.2006.00789.x.
PubMed 16907870Olofsson C, Ahl T, Johansson T, Larsson S, Nellgard P, Ponzer S, Fagrell B, Przybelski R, Keipert P, Winslow N, Winslow RM. A multicenter clinical study of the safety and activity of maleimide-polyethylene glycol-modified Hemoglobin (Hemospan) in patients undergoing major orthopedic surgery. Anesthesiology. 2006 Dec;105(6):1153-63. doi: 10.1097/00000542-200612000-00015.
PubMed 17122578Winslow RM. Red cell substitutes. Semin Hematol. 2007 Jan;44(1):51-9. doi: 10.1053/j.seminhematol.2006.09.013.
PubMed 17198847van der Linden P, Gazdzik TS, Jahoda D, Heylen RJ, Skowronski JC, Pellar D, Kofranek I, Gorecki AZ, Fagrell B, Keipert PE, Hardiman YJ, Levy H; 6090 Study Investigators. A double-blind, randomized, multicenter study of MP4OX for treatment of perioperative hypotension in patients undergoing primary hip arthroplasty under spinal anesthesia. Anesth Analg. 2011 Apr;112(4):759-73. doi: 10.1213/ANE.0b013e31820c7b5f. Epub 2011 Feb 11.
PubMed 21317165
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase III Study of the Efficacy and Safety of an Oxygen-Carrying Plasma Expander, Hemospan®, Compared With Voluven® toTreat Hypotension in Patients Undergoing Primary Hip Arthroplasty With Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT00420277
- Acronym / sponsor ID
- 6090
- Conditions
- Hypotension, Ischemia
- Keywords
- Hip arthroplasty, Anesthesia, spinal, Hypotension, Ischemia, Blood substitutes, Plasma expanders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- SangartIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
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 Hemospan is superior to Voluven for treatment of hypotensive episodes during the perioperative period (from induction of spinal anesthesia until 6 hours after skin closure), and for reducing the incidence of operative and postoperative complications including organ dysfunction and failure until follow-up at one month following surgery. An independent Data Safety Monitoring Board (DSMB) will periodically evaluate the safety data collected during this trial
Detailed description
Hemospan is a novel hemoglobin-based oxygen carrier developed to perfuse and oxygenate tissue at risk for ischemia and hypoxia. As a result of its molecular size and oxygen binding characteristics, Hemospan selectively off-loads oxygen in tissues predisposed to low oxygen tension. Preclinical evidence suggests that Hemospan provides rapid and effective plasma expansion and tissue perfusion, and that the properties of Hemospan target oxygen release in the microcirculation.
Spinal anesthesia is the preferred choice for hip arthroplasty procedures in elderly patients, but is associated with a functional hypovolemia due to loss of vascular tone that frequently causes acute hypotensive episodes. Hypotension represents a surrogate marker of hypovolemia that may be further exacerbated by surgical bleeding, which can result in decreased cardiac output, insufficient perfusion and inadequate tissue oxygenation. Ischemia resulting from hypotension can adversely affect vital organ function and may result in complications and postoperative morbidity. As the population ages and more patients become candidates for orthopedic reconstruction or joint replacement surgery, the number of patients at risk is increasing. The ideal IV solution for treating hypovolemia-associated hypotension and improving hemodynamic stability would be an effective plasma expander that promotes tissue perfusion and delivers oxygen to ischemic or marginally hypoxic tissue.
Preclinical animal studies have shown that Hemospan may be well-suited to this application and may even be better than blood in some situations. Data from Sangart's Phase II orthopedic surgery study (No. 6055), published recently by Olofsson et al. (Anesthesiology 2006; 105(6):1153-63) support the safety and potential benefit of Hemospan for preventing and treating hypotension in orthopedic surgery patients undergoing hip replacement surgery under spinal anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemospan (MP4OX) | Experimental | Drug: Hemospan (MP4OX)4.3 g/dL MalPEG-Hb solution |
| Control | Active comparator | Drug: Voluven (HES 130/0.4)Voluven (HES 130/0.4) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients scheduled to undergo elective primary hip arthroplasty (based on an osteoarthritis diagnosis) under spinal anesthesia
- Adult male or female (surgically sterile or post-menopausal), aged 50 years or older
- American Society of Anesthesiology (ASA) Class II or III
- Physical examination, laboratory status, vital signs, and ECG within acceptable limits for the planned surgery, as judged by the investigator
- Have been given written and verbal information by the investigator about Hemospan and the protocol, and have had the opportunity to ask questions about the study
Key exclusion criteria (9 listed)
- Hip fracture patients and nail/pin extraction procedures
- Clinical evidence of uncontrolled cardiovascular, infectious, psychiatric, metabolic or systemic disorders including diabetes and rheumatoid arthritis
- Evidence of significant hypertension with SBP >180 mmHg, or a difference in SBP obtained in each arm that is >15 mmHg (measured in the supine position in both arms, at screening)
- Recent history or evidence of MI or stroke (within 6 months)
- Known alcohol or drug dependency
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 |
|---|---|---|
| Hemospan (MP4OX)Also: MP4OX solution, 4.3 g/dL MalPEG-Hb, PEGylated Hb250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers | Drug | Hemospan (MP4OX) |
| Voluven (HES 130/0.4)Also: 6% HES 130/0.4, 6% hetastarch solution, Voluven250 mL unit dose, up to 500 mL total dose as needed at protocol-defined dosing triggers | Drug | Control |
Primary outcome
Total duration of all hypotensive episodes occurring during anesthesia/surgery and throughout the postoperative period (defined as the first 6 hours following skin closure)
Time frame: Up to 6 hours after skin closure
10 secondary outcomes
Incidence of serious operative and postoperative complications, combined into a Composite Morbidity Outcome that includes acute heart failure, acute MI, ischemic stroke, and renal failure
Time frame: 30 days
Incidence of operative and postoperative organ dysfunction related to ischemia and/or tissue hypoxia, as a Composite Ischemia Outcome that includes clinical evidence of cerebral ischemia, myocardial ischemia, and renal dysfunction
Time frame: 30 days
Mortality (In-hospital, and all-cause at 30 days)
Time frame: 30 days
Time to resolve/correct the initial hypotensive episode that led to the first dosing trigger
Time frame: Intraoperative
Time to the second dosing trigger from the first dosing trigger
Time frame: Intraoperative
Proportion of patients treated successfully with one dose
Time frame: Intraoperative
Incidence of hypotension
Time frame: Up to 6 hours after skin closure
Duration of the longest period of hypotension recorded
Time frame: Up to 6 hours after skin closure
Incidence of intervention with a pressor agent to treat hypotensive episodes
Time frame: Up to 6 hours after skin closure
Incidence of postoperative intervention with a diuretic for volume-overload or inadequate urine output
Time frame: Post-operative day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2013.
- Background: PubMed 15820947Bjorkholm M, Fagrell B, Przybelski R, Winslow N, Young M, Winslow RM. A phase I single blind clinical trial of a new oxygen transport agent (MP4), human hemoglobin modified with maleimide-activated polyethylene glycol. Haematologica. 2005 Apr;90(4):505-15.
- Background: PubMed 15637119Cabrales P, Tsai AG, Winslow RM, Intaglietta M. Effects of extreme hemodilution with hemoglobin-based O2 carriers on microvascular pressure. Am J Physiol Heart Circ Physiol. 2005 May;288(5):H2146-53. doi: 10.1152/ajpheart.00749.2004. Epub 2005 Jan 6.
- Background: PubMed 16096458Young MA, Riddez L, Kjellstrom BT, Bursell J, Winslow F, Lohman J, Winslow RM. MalPEG-hemoglobin (MP4) improves hemodynamics, acid-base status, and survival after uncontrolled hemorrhage in anesthetized swine. Crit Care Med. 2005 Aug;33(8):1794-804. doi: 10.1097/01.ccm.0000172648.55309.13.
- Background: PubMed 16857991Tsai AG, Cabrales P, Manjula BN, Acharya SA, Winslow RM, Intaglietta M. Dissociation of local nitric oxide concentration and vasoconstriction in the presence of cell-free hemoglobin oxygen carriers. Blood. 2006 Nov 15;108(10):3603-10. doi: 10.1182/blood-2006-02-005272. Epub 2006 Jul 20.
- Background: PubMed 16907870Winslow RM. Current status of oxygen carriers ('blood substitutes'): 2006. Vox Sang. 2006 Aug;91(2):102-10. doi: 10.1111/j.1423-0410.2006.00789.x.
- Background: PubMed 17122578Olofsson C, Ahl T, Johansson T, Larsson S, Nellgard P, Ponzer S, Fagrell B, Przybelski R, Keipert P, Winslow N, Winslow RM. A multicenter clinical study of the safety and activity of maleimide-polyethylene glycol-modified Hemoglobin (Hemospan) in patients undergoing major orthopedic surgery. Anesthesiology. 2006 Dec;105(6):1153-63. doi: 10.1097/00000542-200612000-00015.
- Background: PubMed 17198847Winslow RM. Red cell substitutes. Semin Hematol. 2007 Jan;44(1):51-9. doi: 10.1053/j.seminhematol.2006.09.013.
- Results publication: PubMed 21317165van der Linden P, Gazdzik TS, Jahoda D, Heylen RJ, Skowronski JC, Pellar D, Kofranek I, Gorecki AZ, Fagrell B, Keipert PE, Hardiman YJ, Levy H; 6090 Study Investigators. A double-blind, randomized, multicenter study of MP4OX for treatment of perioperative hypotension in patients undergoing primary hip arthroplasty under spinal anesthesia. Anesth Analg. 2011 Apr;112(4):759-73. doi: 10.1213/ANE.0b013e31820c7b5f. Epub 2011 Feb 11.
- Click here for more information about Sangart, Inc.Link provided by the sponsor.
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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.
Philippe van der Linden, MD, PhD principal investigator
CHU Brugmann, Brussels
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hemospan (MP4OX) and Voluven (HES 130/0.4) in people with Hypotension and Ischemia, run by Sangart at 22 sites in 5 countries.
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 6 inclusion and 9 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 19 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Sweden, Poland, Czechia, Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total duration of all hypotensive episodes occurring during anesthesia/surgery and throughout the postoperative period (defined as the first 6 hours following skin closure) (time frame: Up to 6 hours after skin closure). 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 NCT00420277, which also lists 8 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 19 Aug 2013.