Intraoperative ComplicationsNCT04256928
The Effect of Hair Removal on Intraoperative Contamination
A study testing Preoperative electrical clipping in people with Intraoperative Complications, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
A prospective, non-blinded, randomized controlled trial with the purpose of investigating, whether preoperative electrical clipping of body hair affects the risk of intraoperative contamination. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Intraoperative Complications
- What is being tested?
- Preoperative electrical clipping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2020to 30 Jul 2020
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned primary knee replacement surgery
Who cannot join
- Known skin disease
- Use of antibiotics 4 weeks prior to surgery
- If patients due to mental reasons, a language barrier or other reasons are unable to participate in the study
- No body hair in the surgical field
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Ortopædkirurgisk Afdeling T, Herlev og Gentofte Hospital
Hellerup, 2900
Ditte Harder, Student, +4538673364, ditte.marie.bak.harder@regionh.dk
About this study
A prospective, non-blinded, randomized controlled trial with the purpose of investigating, whether preoperative electrical clipping of body hair affects the risk of intraoperative contamination.
The primary investigators hypothesis is this: Preoperative electrical clipping of body hair in the operative field lowers the risk of intraoperative contamination.
Read more
200 male participants, 18 years or older, with a planned primary knee replacement surgery, will be enrolled.
During surgery, four microbiological samples will be taken from each participant.
The primary outcome is whether there is intraoperative contamination of the surgical site or not, determined by identification of any grown bacteria from the samples.
If this study finds, that the contamination rate is lowered by preoperative electrical clipping of body hair, it will provide a cost-effective method of reducing the risk of intraoperative contamination and consequent postoperative infection, a solid argument for a change of current guidelines for preoperative hair removal, and provide additional information pointing towards body hair as a possible explanation for the increased infection rate in men.
Read the detailed description
A late ph.d.-study conducted at Herlev and Gentofte Hospital has shown a 15 percentage difference in contamination rates when comparing participants who had their body hair removed preoperatively, and those who did not.
Based on the finds in the aforementioned study, the hypothesis for this study is that preoperative electrical clipping of body hair in the operative field lowers the risk of intraoperative contamination.
The purpose of this study is to investigate, whether preoperative electrical clipping of body hair affects the risk of intraoperative contamination.
A prospective, non-blinded, randomized controlled trial will be performed. The study population consists of 200 male patients, 18 years or older, with a planned primary knee replacement surgery. The study population consists of only male patients, since males generally have denser body hair and a higher contamination rate than females. Exclusion criteria include known skin disease, use of antibiotics 4 weeks prior to surgery, if patients due to mental reasons, a language barrier or other reasons are unable to participate in the study, as well as no body hair in the surgical field.
Participants will be randomized to either the intervention group (preoperative electrical clipping) or the control group (leaving the body hair intact) using a 1:1 randomization ratio. The randomization is performed electronically by a medical student or the operating surgeon and the pre-assessment consultation.
Clipping is performed by hospital staff on the day of surgery. The degree of body hair on both knees is photo-documented for all participants, for the intervention group after the clipping of body hair on the relevant knee has been performed.
During the surgery, biological material from every participant is collected as four microbiological samples, taken using Copan ESwabs. The first swab is taken before the skin is surgically prepared, the second immediately after incision of the skin, the third swab is taken just prior to the change of gloves performed before cementation of the prothesis, and the last swab is taken after closure of the joint capsule before closure of the skin. Samples will be collected at Orthopedic Departments of Gentofte Hospital. All samples will be sent to Department of Clinical Microbiology, Herlev Hospital, for culturing.The bacteria will be identified following Danish guidelines.
The material consists of culture results from all samples. The primary outcome is whether there is intraoperative contamination of the surgical site or not. This is determined by identification of any grown bacteria.The material will be statistically analyzed using the program R Studio. Since data is categorial, a chi-squared test will be performed to evaluate the significance of the possible difference of contamination rate in the two participant groups.
All possibilities for conducting the study are known to exist, as the method described above has previously been used in the PhD study conducted at the department: "Intraoperative microbial contamination, its prevention and its consequences for outcomes following knee replacement surgery- The ICON study".
Personal data is processed as part of the project. All handling and processing of personal data follows the Data Protection Regulation and the Data Protection Act.
Data collected during the pre-assessment consultation will be entered directly into a database. Only data in this database will be available to the investigators conducting the study, for further analysis. Information about the microbiological samples and cultures will be entered into the database as well. All information in the database will be anonymized 2 years after collection of data is complete.
By consenting to participating in this study, participants also consent to the investigators conducting the study, Herlev-Gentofte Hospital and their representatives to be given direct access to the collected data. Consenting to participate also involves consenting that the Regional Committee on Health Research Ethics are allowed direct access to all data collected, to facilitate their control with the project.
If this study finds, that the contamination rate is lowered by preoperative electrical clipping of body hair, it will not only provide a cost-effective method to reduce the risk of intraoperative contamination and consequent postoperative infection, but may also lead to a change of current guidelines to preoperative electrical clipping of body hair becoming a permanent practice. In addition, the study will confirm existing finds pointing towards body hair as a possible explanation for the increased infection rate in men.
A decrease in the incidence of infections will save patients from unpleasant and often prolonged consequences of infection, including pain, revisions, antibiotic treatments and, at worst, loss of mobility. In addition, fewer infections will lead to savings in the health care system, with the release of funds and beds, to the benefit of patients in general and the social economy.
- Conditions
- Intraoperative Complications
- Being tested
- Preoperative electrical clipping
- Medical subject headings
- Intraoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative electrical clippingProcedure or surgery
Body hair in the operative field will be clipped with an electrical clipper by hospital personnel during preparation to planned surgery.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This group of participants will have any body hair in the operative field clipped with an electrical clipper by hospital personnel, during preparation for planned surgery.
4 microbiological samples will be taken from all participants in this group. Receives: Procedure: Preoperative electrical clipping |
| Control group | No intervention | This group of participants serve as the control group. Any body hair in the operative field is left intact. 4 microbiological samples will be taken from all participants in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative contamination rate
Rate of contamination as amount of indentified bacteria cultured.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Feb 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Intraoperative ComplicationsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either the intervention group (preoperative electrical clipping) clipping or the control group (leaving the body hair intact) using a 1:1 randomization ratio. The randomization is performed electronically by a medical student or the operating surgeon and the pre-assessment consultation. Hair removal is performed with an electric clipper. Clipping is performed by hospital staff on the day of surgery. The degree of body hair on both knees is photo-documented for all participants, for the intervention group after the clipping of body hair on the relevant knee has been performed. 4 microbiological samples will be taken during surgery from each participant using Copan ESwabs.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ditte Harder, Herlev and Gentofte Hospital
- Investigators
- Ditte Harder, Student, Principal investigator, Herlev og Gentofte Hospital, Ortopædkirurgisk Afdeling T
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256928
- Sponsor's protocol ID
- 70136
- Status last verified
- Feb 2020
- First submitted
- 31 Jan 2020
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual partcipant data, but anonymized data can be made available upon request after publication of the study.
Publications
Hesselvig AB, Bjarnsholt T, Arpi M, Madsen F, Odgaard A, group ObotIs. The use of iodine impregnated incision drape in knee arthroplasty surgery - a prospective, randomized trial.
Gallo J, Kolar M, Novotny R, Rihakova P, Ticha V. Pathogenesis of prosthesis-related infection. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2003 Nov;147(1):27-35. doi: 10.5507/bp.2003.004.
PubMed 15034602Byrne AM, Morris S, McCarthy T, Quinlan W, O'byrne JM. Outcome following deep wound contamination in cemented arthroplasty. Int Orthop. 2007 Feb;31(1):27-31. doi: 10.1007/s00264-006-0121-z. Epub 2006 Apr 4.
PubMed 16586132Jonsson EO, Johannesdottir H, Robertsson O, Mogensen B. Bacterial contamination of the wound during primary total hip and knee replacement. Median 13 years of follow-up of 90 replacements. Acta Orthop. 2014 Apr;85(2):159-64. doi: 10.3109/17453674.2014.899848.
PubMed 24650025Al-Maiyah M, Hill D, Bajwa A, Slater S, Patil P, Port A, Gregg PJ. Bacterial contaminants and antibiotic prophylaxis in total hip arthroplasty. J Bone Joint Surg Br. 2005 Sep;87(9):1256-8. doi: 10.1302/0301-620X.87B9.15685.
PubMed 16129753Webster J, Alghamdi A. Use of plastic adhesive drapes during surgery for preventing surgical site infection. Cochrane Database Syst Rev. 2015 Apr 22;2015(4):CD006353. doi: 10.1002/14651858.CD006353.pub4.
PubMed 25901509Falk-Brynhildsen K, Friberg O, Soderquist B, Nilsson UG. Bacterial colonization of the skin following aseptic preoperative preparation and impact of the use of plastic adhesive drapes. Biol Res Nurs. 2013 Apr;15(2):242-8. doi: 10.1177/1099800411430381. Epub 2012 Jan 24.
PubMed 22278031Grice EA, Kong HH, Renaud G, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Wolfsberg TG, Turner ML, Segre JA. A diversity profile of the human skin microbiota. Genome Res. 2008 Jul;18(7):1043-50. doi: 10.1101/gr.075549.107. Epub 2008 May 23.
PubMed 18502944Arnold WV, Shirtliff ME, Stoodley P. Bacterial biofilms and periprosthetic infections. Instr Course Lect. 2014;63:385-91.
PubMed 24720323Aboltins C, Daffy J, Choong P, Stanley P. Current concepts in the management of prosthetic joint infection. Intern Med J. 2014 Sep;44(9):834-40. doi: 10.1111/imj.12510.
PubMed 24942508Trampuz A, Zimmerli W. Prosthetic joint infections: update in diagnosis and treatment. Swiss Med Wkly. 2005 Apr 30;135(17-18):243-51. doi: 10.4414/smw.2005.10934.
PubMed 15965826Lange-Asschenfeldt B, Marenbach D, Lang C, Patzelt A, Ulrich M, Maltusch A, Terhorst D, Stockfleth E, Sterry W, Lademann J. Distribution of bacteria in the epidermal layers and hair follicles of the human skin. Skin Pharmacol Physiol. 2011;24(6):305-11. doi: 10.1159/000328728. Epub 2011 Jul 15.
PubMed 21757977Jose B, Dignon A. Is there a relationship between preoperative shaving (hair removal) and surgical site infection? J Perioper Pract. 2013 Jan-Feb;23(1-2):22-5. doi: 10.1177/1750458913023001-203.
PubMed 23413532Pan A, Ambrosini L, Patroni A, Soavi L, Signorini L, Carosi G, Santini C; Gruppo Italiano di Studio sulle Infezioni in Cardiochirurgia Study Group. Adherence to surgical site infection guidelines in Italian cardiac surgery units. Infection. 2009 Apr;37(2):148-52. doi: 10.1007/s15010-008-7474-8. Epub 2009 Mar 23.
PubMed 19308319Broekman ML, van Beijnum J, Peul WC, Regli L. Neurosurgery and shaving: what's the evidence? J Neurosurg. 2011 Oct;115(4):670-8. doi: 10.3171/2011.5.JNS102003. Epub 2011 Jul 1.
PubMed 21721875
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hair Removal on Intraoperative Contamination
- ClinicalTrials.gov ID
- NCT04256928
- Acronym / sponsor ID
- 70136
- Conditions
- Intraoperative Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 15 Feb 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 5 Feb 2020 (actual)
- 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.
A prospective, non-blinded, randomized controlled trial with the purpose of investigating, whether preoperative electrical clipping of body hair affects the risk of intraoperative contamination.
The primary investigators hypothesis is this: Preoperative electrical clipping of body hair in the operative field lowers the risk of intraoperative contamination.
200 male participants, 18 years or older, with a planned primary knee replacement surgery, will be enrolled.
During surgery, four microbiological samples will be taken from each participant.
The primary outcome is whether there is intraoperative contamination of the surgical site or not, determined by identification of any grown bacteria from the samples.
If this study finds, that the contamination rate is lowered by preoperative electrical clipping of body hair, it will provide a cost-effective method of reducing the risk of intraoperative contamination and consequent postoperative infection, a solid argument for a change of current guidelines for preoperative hair removal, and provide additional information pointing towards body hair as a possible explanation for the increased infection rate in men.
Detailed description
A late ph.d.-study conducted at Herlev and Gentofte Hospital has shown a 15 percentage difference in contamination rates when comparing participants who had their body hair removed preoperatively, and those who did not.
Based on the finds in the aforementioned study, the hypothesis for this study is that preoperative electrical clipping of body hair in the operative field lowers the risk of intraoperative contamination.
The purpose of this study is to investigate, whether preoperative electrical clipping of body hair affects the risk of intraoperative contamination.
A prospective, non-blinded, randomized controlled trial will be performed. The study population consists of 200 male patients, 18 years or older, with a planned primary knee replacement surgery. The study population consists of only male patients, since males generally have denser body hair and a higher contamination rate than females. Exclusion criteria include known skin disease, use of antibiotics 4 weeks prior to surgery, if patients due to mental reasons, a language barrier or other reasons are unable to participate in the study, as well as no body hair in the surgical field.
Participants will be randomized to either the intervention group (preoperative electrical clipping) or the control group (leaving the body hair intact) using a 1:1 randomization ratio. The randomization is performed electronically by a medical student or the operating surgeon and the pre-assessment consultation.
Clipping is performed by hospital staff on the day of surgery. The degree of body hair on both knees is photo-documented for all participants, for the intervention group after the clipping of body hair on the relevant knee has been performed.
During the surgery, biological material from every participant is collected as four microbiological samples, taken using Copan ESwabs. The first swab is taken before the skin is surgically prepared, the second immediately after incision of the skin, the third swab is taken just prior to the change of gloves performed before cementation of the prothesis, and the last swab is taken after closure of the joint capsule before closure of the skin. Samples will be collected at Orthopedic Departments of Gentofte Hospital. All samples will be sent to Department of Clinical Microbiology, Herlev Hospital, for culturing.The bacteria will be identified following Danish guidelines.
The material consists of culture results from all samples. The primary outcome is whether there is intraoperative contamination of the surgical site or not. This is determined by identification of any grown bacteria.The material will be statistically analyzed using the program R Studio. Since data is categorial, a chi-squared test will be performed to evaluate the significance of the possible difference of contamination rate in the two participant groups.
All possibilities for conducting the study are known to exist, as the method described above has previously been used in the PhD study conducted at the department: "Intraoperative microbial contamination, its prevention and its consequences for outcomes following knee replacement surgery- The ICON study".
Personal data is processed as part of the project. All handling and processing of personal data follows the Data Protection Regulation and the Data Protection Act.
Data collected during the pre-assessment consultation will be entered directly into a database. Only data in this database will be available to the investigators conducting the study, for further analysis. Information about the microbiological samples and cultures will be entered into the database as well. All information in the database will be anonymized 2 years after collection of data is complete.
By consenting to participating in this study, participants also consent to the investigators conducting the study, Herlev-Gentofte Hospital and their representatives to be given direct access to the collected data. Consenting to participate also involves consenting that the Regional Committee on Health Research Ethics are allowed direct access to all data collected, to facilitate their control with the project.
If this study finds, that the contamination rate is lowered by preoperative electrical clipping of body hair, it will not only provide a cost-effective method to reduce the risk of intraoperative contamination and consequent postoperative infection, but may also lead to a change of current guidelines to preoperative electrical clipping of body hair becoming a permanent practice. In addition, the study will confirm existing finds pointing towards body hair as a possible explanation for the increased infection rate in men.
A decrease in the incidence of infections will save patients from unpleasant and often prolonged consequences of infection, including pain, revisions, antibiotic treatments and, at worst, loss of mobility. In addition, fewer infections will lead to savings in the health care system, with the release of funds and beds, to the benefit of patients in general and the social economy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to either the intervention group (preoperative electrical clipping) clipping or the control group (leaving the body hair intact) using a 1:1 randomization ratio. The randomization is performed electronically by a medical student or the operating surgeon and the pre-assessment consultation. Hair removal is performed with an electric clipper. Clipping is performed by hospital staff on the day of surgery. The degree of body hair on both knees is photo-documented for all participants, for the intervention group after the clipping of body hair on the relevant knee has been performed. 4 microbiological samples will be taken during surgery from each participant using Copan ESwabs.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Preoperative electrical clippingThis group of participants will have any body hair in the operative field clipped with an electrical clipper by hospital personnel, during preparation for planned surgery. 4 microbiological samples will be taken from all participants in this group. |
| Control group | No intervention | –This group of participants serve as the control group. Any body hair in the operative field is left intact. 4 microbiological samples will be taken from all participants in this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planned primary knee replacement surgery
Key exclusion criteria (4 listed)
- Known skin disease
- Use of antibiotics 4 weeks prior to surgery
- If patients due to mental reasons, a language barrier or other reasons are unable to participate in the study
- No body hair in the surgical field
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 |
|---|---|---|
| Preoperative electrical clippingBody hair in the operative field will be clipped with an electrical clipper by hospital personnel during preparation to planned surgery. | Procedure or surgery | Intervention group |
Primary outcome
Intraoperative contamination rate
Time frame: 1 year
Rate of contamination as amount of indentified bacteria cultured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- BackgroundHesselvig AB, Bjarnsholt T, Arpi M, Madsen F, Odgaard A, group ObotIs. The use of iodine impregnated incision drape in knee arthroplasty surgery - a prospective, randomized trial.
- Background: PubMed 15034602Gallo J, Kolar M, Novotny R, Rihakova P, Ticha V. Pathogenesis of prosthesis-related infection. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2003 Nov;147(1):27-35. doi: 10.5507/bp.2003.004.
- Background: PubMed 16586132Byrne AM, Morris S, McCarthy T, Quinlan W, O'byrne JM. Outcome following deep wound contamination in cemented arthroplasty. Int Orthop. 2007 Feb;31(1):27-31. doi: 10.1007/s00264-006-0121-z. Epub 2006 Apr 4.
- Background: PubMed 24650025Jonsson EO, Johannesdottir H, Robertsson O, Mogensen B. Bacterial contamination of the wound during primary total hip and knee replacement. Median 13 years of follow-up of 90 replacements. Acta Orthop. 2014 Apr;85(2):159-64. doi: 10.3109/17453674.2014.899848.
- Background: PubMed 16129753Al-Maiyah M, Hill D, Bajwa A, Slater S, Patil P, Port A, Gregg PJ. Bacterial contaminants and antibiotic prophylaxis in total hip arthroplasty. J Bone Joint Surg Br. 2005 Sep;87(9):1256-8. doi: 10.1302/0301-620X.87B9.15685.
- Background: PubMed 25901509Webster J, Alghamdi A. Use of plastic adhesive drapes during surgery for preventing surgical site infection. Cochrane Database Syst Rev. 2015 Apr 22;2015(4):CD006353. doi: 10.1002/14651858.CD006353.pub4.
- Background: PubMed 22278031Falk-Brynhildsen K, Friberg O, Soderquist B, Nilsson UG. Bacterial colonization of the skin following aseptic preoperative preparation and impact of the use of plastic adhesive drapes. Biol Res Nurs. 2013 Apr;15(2):242-8. doi: 10.1177/1099800411430381. Epub 2012 Jan 24.
- Background: PubMed 18502944Grice EA, Kong HH, Renaud G, Young AC; NISC Comparative Sequencing Program; Bouffard GG, Blakesley RW, Wolfsberg TG, Turner ML, Segre JA. A diversity profile of the human skin microbiota. Genome Res. 2008 Jul;18(7):1043-50. doi: 10.1101/gr.075549.107. Epub 2008 May 23.
- Background: PubMed 24720323Arnold WV, Shirtliff ME, Stoodley P. Bacterial biofilms and periprosthetic infections. Instr Course Lect. 2014;63:385-91.
- Background: PubMed 24942508Aboltins C, Daffy J, Choong P, Stanley P. Current concepts in the management of prosthetic joint infection. Intern Med J. 2014 Sep;44(9):834-40. doi: 10.1111/imj.12510.
- Background: PubMed 15965826Trampuz A, Zimmerli W. Prosthetic joint infections: update in diagnosis and treatment. Swiss Med Wkly. 2005 Apr 30;135(17-18):243-51. doi: 10.4414/smw.2005.10934.
- Background: PubMed 21757977Lange-Asschenfeldt B, Marenbach D, Lang C, Patzelt A, Ulrich M, Maltusch A, Terhorst D, Stockfleth E, Sterry W, Lademann J. Distribution of bacteria in the epidermal layers and hair follicles of the human skin. Skin Pharmacol Physiol. 2011;24(6):305-11. doi: 10.1159/000328728. Epub 2011 Jul 15.
- Individual participant dataSharing planned: No. There is no plan to share individual partcipant data, but anonymized data can be made available upon request after publication of the study.
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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.
Ditte Harder, Student principal investigator
Herlev og Gentofte Hospital, Ortopædkirurgisk Afdeling T
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative electrical clipping in people with Intraoperative Complications, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ditte Harder, Student (+4538673364, ditte.marie.bak.harder@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative contamination rate (time frame: 1 year). 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 NCT04256928, which also lists 20 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 10 Feb 2020.