HysterectomyNCT03917134
Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy
A study testing cephalosporin + Metronidazole Vaginal in people with Hysterectomy and Cellulitis, run by CES University at 2 sites in Colombia.
Trial summary
Operative site infection remains the most common complication after performing a gynecological procedure, and has a great implication in the morbidity and mortality of patients. Gynecological procedures, including laparoscopic hysterectomy, represent a unique challenge due to the amount of microorganisms found at the… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Hysterectomy, Cellulitis, Vaginosis
- What is being tested?
- cephalosporin + Metronidazole Vaginal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 2 sitesColombia
- Study dates
- 1 May 2019to 30 Jan 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients between 18 and 55 years old scheduled for laparoscopic hysterectomy for benign pathology in the two centers linked to the study (Clínica del Prado and Pereira community clinic), who have been informed of their participation in the study and who have signed informed consent.
- Patients who are able to communicate by telephone and answer questions
Who cannot join
- Patients who are participating in another study of antibiotic treatment.
- Patients who have a known allergy to imidazole medications.
- Patients with current diagnosis of bacterial vaginosis.
- Patients with current treatment or 30 days prior to surgery for bacterial vaginosis or antibiotic treatment for another pathology.
- Patients who do not reside in Medellín or in its nearby municipalities and can not attend the scheduled evaluation.
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites
Clinica del prado
Medellín
5745765700
CLAUDIA LOPEZ, Gynecologist
Clínica comfamiliar pereira
Pereira
5763135700
JUAN D VILLEGAS, Gynecologist
About this study
Official title: Efficacy of the Use of Metronidazole After Laparoscopic Hysterectomy for the Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess. Multicentric Triple-blind Randomized Controlled Trial
Operative site infection remains the most common complication after performing a gynecological procedure, and has a great implication in the morbidity and mortality of patients. Gynecological procedures, including laparoscopic hysterectomy, represent a unique challenge due to the amount of microorganisms found at the skin level of the vagina or the endocervix.
However, there is no clear evidence that the complication decreases with the use of postoperative antibiotics.
Read more
With the completion of this study, a multicentre triple-blind controlled randomized controlled trial is intended to determine the behavior of the application of this intervention.
Patients who attend an outpatient clinic with benign pathology will be selected, in which indication of laparoscopic hysterectomy, consents are completed and research content is widely explained. Prior to surgery, the sample is taken for a gram of vaginal discharge and in the post-surgical phase delivery of the medication will be performed. Follow-up will be carried out by surgical control and by telephone.
The investigator intend to find that with the prophylaxis not only of presurgical cephalosporin, but with the formulation of metronidazole ovules in the postoperative, the incidence of laparoscopic post-hysterectomy vaginal abscess and cellulitis of cuff is reduced.
Read the detailed description
The development of the project will be carried out in the facilities of the Prado clinic in the city of Medellín and the Comfamily Clinic in the city of Pereira. Initially to the participants who attend by external consultation for assessment by the laparoscopic gynecology group that are candidates to perform a laparoscopic hysterectomy, they will be given general information about the research in development and its possible participation. Later on the day of surgery in the preparation room and before receiving any medication, The assigned investigator as assistant to the surgery will explain in detail the protocol of the investigation, the commitments acquired by the participant and the possibilities of withdrawal of the same, you will obtain the signature and trace of the informed consent. With the aim of not delaying the 7 am surgical program, a weekly resident will be assigned to inform and fill out the forms of the first patients scheduled for hysterectomy.
Advance by means of a table of random numbers generated in EPIDAT and that is hidden for the researcher. Participants will be assigned to one of the 2 groups, the intervention group will receive the treatment scheme with metronidazole 500mg ovules every 12 hours for 5 days and the control group will receive a placebo.
After this in the surgery room and with the participants under general anesthesia, the sample will be taken for gram of vaginal discharge, previous marking of the plate, with the initials of names and surnames and the patient's identification number, With the use of a speculum and applicator the sample will be taken in the sack bottoms or vaginal walls, which will be sent to the Prolab laboratory in the city of Medellín and the laboratory of the Comfamily clinic in the city of Pereira. for its processing, standardization will be made prior to reading it with the staff of both laboratories.
For the diagnosis of bacterial vaginosis, the Nugent criteria will be used. In this method, the morphotypes corresponding to large Gram-positive bacilli, small Gram-negative bacilli and curved variable Gram bacilli are quantified. And a value is assigned according to the findings. The interpretation of the results is numerical based on the score obtained by adding the crosses of the morphotypes of the bacteria present in the vaginal discharge: 7 or more points are diagnostic of bacterial vaginosis, from 4 to 6 points is considered intermediate and from 0 to 3 is considered normal.
At the end of the surgical procedure, the investigator will complete the completion of Annex 1, will go to the pharmaceutical service where he will request the corresponding product to the patient. The pharmacy staff will verify the assigned number in the randomization table and deliver the medication and the resident will take it to the recovery room with its respective formula.
The assigned investigator will conduct a telephone interview 7 days after the procedure to assess the post-surgical evolution, will be questioned about the presence of symptoms that may be related to an infectious process. Between 10-15 days of the surgical procedure, the gynecologist will perform the post-surgical review in an outpatient clinic to assess the evolution of the patient and re-evaluate the result of the pathology. The Gram result of vaginal discharge, the pathology and the evolution note made by the surgeon will be reviewed with the aim of detecting any diagnosed complication. Finally, 30 days after the procedure, the last telephone follow-up will be performed to detect the presence of any infection. of the operative site.
- Conditions
- Hysterectomy, Cellulitis, Vaginosis, Abscess, Cuff
- Being tested
- cephalosporin + Metronidazole Vaginal, cephalosporin + Placebos
- Medical subject headings
- Cellulitis, Vaginal Diseases, Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cephalosporin + Metronidazole VaginalDrug
administration of cephalosporin in doses of 2 grams administered intravenously before surgery and metronidazole vaginal ovules 500mg twice a day for 5 days after performing laparoscopic hysterectomy
cephalosporin + PlacebosDrug
administration of cephalosporin in doses of 2 grams administered intravenously before surgery and vaginal ovules of placebo twice a day for 5 days after performing laparoscopic hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| cephalosporin + Metronidazole | Experimental | In this arm, patients randomly selected, will receive cephalosporin in doses of 2 grams administered intravenously before surgery. metronidazole vaginal ovules of 500mg twice a day for 5 days after surgery Receives: Drug: cephalosporin + Metronidazole Vaginal |
| cephalosporin + placebo | Placebo comparator | In this arm, patients randomly selected, will receive cephalosporin in doses of 2 grams administered intravenously before surgery. placebo vaginal ovules twice a day for 5 days after surgery Receives: Drug: cephalosporin + Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cellulitis and vaginal cuff abscess
Measured: 30 days
Secondary outcomes (3)
percentage of patients who will undergo laparoscopic hysterectomy have bacterial vaginosis at the time of the procedure.
Measured: 15 days
need to perform additional procedures as part of the treatment in each of the groups.
Measured: 30 days
percentage of patients who comply with the prescribed treatment completely.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 May 2019 (estimated)
- Primary completion30 Jan 2020 (estimated)
- Study completion30 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CES University
- Sponsor type
- University, hospital or other
- Collaborators
- Lafrancol S.A., Prolab S.A, Clínica del prado, Clínica comfamiliar pereira
- Responsible party
- Principal investigator, Claudia López, CES University
- Investigators
- CLAUDIA LOPEZ, Gynecologist, Principal investigator, CES University - Clínica del prado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917134
- Sponsor's protocol ID
- 815
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 16 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
ACOG practice bulletin No. 104: antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol. 2009 May;113(5):1180-1189. doi: 10.1097/AOG.0b013e3181a6d011. No abstract available.
PubMed 19384149Lowe NK, Neal JL, Ryan-Wenger NA. Accuracy of the clinical diagnosis of vaginitis compared with a DNA probe laboratory standard. Obstet Gynecol. 2009 Jan;113(1):89-95. doi: 10.1097/AOG.0b013e3181909f63.
PubMed 19104364Brachman PS, Dan BB, Haley RW, Hooton TM, Garner JS, Allen JR. Nosocomial surgical infections: incidence and cost. Surg Clin North Am. 1980 Feb;60(1):15-25. doi: 10.1016/s0039-6109(16)42030-x.
PubMed 7361218Persson E, Bergstrom M, Larsson PG, Moberg P, Platz-Christensen JJ, Schedvins K, Wolner-Hanssen P. Infections after hysterectomy. A prospective nation-wide Swedish study. The Study Group on Infectious Diseases in Obstetrics and Gynecology within the Swedish Society of Obstetrics and Gynecology. Acta Obstet Gynecol Scand. 1996 Sep;75(8):757-61. doi: 10.3109/00016349609065742.
PubMed 8906013Oduyebo OO, Anorlu RI, Ogunsola FT. The effects of antimicrobial therapy on bacterial vaginosis in non-pregnant women. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006055. doi: 10.1002/14651858.CD006055.pub2.
PubMed 19588379Joesoef MR, Schmid GP, Hillier SL. Bacterial vaginosis: review of treatment options and potential clinical indications for therapy. Clin Infect Dis. 1999 Jan;28 Suppl 1:S57-65. doi: 10.1086/514725.
PubMed 10028110Larsson PG, Carlsson B. Does pre- and postoperative metronidazole treatment lower vaginal cuff infection rate after abdominal hysterectomy among women with bacterial vaginosis? Infect Dis Obstet Gynecol. 2002;10(3):133-40. doi: 10.1155/S1064744902000133.
PubMed 12625969Larsson PG. Treatment of bacterial vaginosis. Int J STD AIDS. 1992 Jul-Aug;3(4):239-47. doi: 10.1177/095646249200300402. No abstract available.
PubMed 1504154McElligott KA, Havrilesky LJ, Myers ER. Preoperative screening strategies for bacterial vaginosis prior to elective hysterectomy: a cost comparison study. Am J Obstet Gynecol. 2011 Nov;205(5):500.e1-7. doi: 10.1016/j.ajog.2011.07.012. Epub 2011 Jul 20.
PubMed 21944221Schey D, Salom EM, Papadia A, Penalver M. Extensive fever workup produces low yield in determining infectious etiology. Am J Obstet Gynecol. 2005 May;192(5):1729-34. doi: 10.1016/j.ajog.2004.11.049.
PubMed 15902186Makinen J, Johansson J, Tomas C, Tomas E, Heinonen PK, Laatikainen T, Kauko M, Heikkinen AM, Sjoberg J. Morbidity of 10 110 hysterectomies by type of approach. Hum Reprod. 2001 Jul;16(7):1473-8. doi: 10.1093/humrep/16.7.1473.
PubMed 11425832Faro C, Faro S. Postoperative pelvic infections. Infect Dis Clin North Am. 2008 Dec;22(4):653-663. doi: 10.1016/j.idc.2008.05.005.
PubMed 18954757Lake AG, McPencow AM, Dick-Biascoechea MA, Martin DK, Erekson EA. Surgical site infection after hysterectomy. Am J Obstet Gynecol. 2013 Nov;209(5):490.e1-9. doi: 10.1016/j.ajog.2013.06.018. Epub 2013 Jun 13.
PubMed 23770467Tamussino K. Postoperative infection. Clin Obstet Gynecol. 2002 Jun;45(2):562-73. doi: 10.1097/00003081-200206000-00026. No abstract available.
PubMed 12048413Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568. No abstract available.
PubMed 23327981
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Use of Metronidazole After Laparoscopic Hysterectomy for the Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess. Multicentric Triple-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03917134
- Acronym / sponsor ID
- 815
- Conditions
- Hysterectomy, Cellulitis, Vaginosis, Abscess, Cuff
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- CES UniversityUniversity, hospital or other
- Collaborators
- Lafrancol S.A., Prolab S.A, Clínica del prado, Clínica comfamiliar pereira
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 30 Jan 2020 (estimated)
- First posted
- 16 Apr 2019 (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.
Operative site infection remains the most common complication after performing a gynecological procedure, and has a great implication in the morbidity and mortality of patients. Gynecological procedures, including laparoscopic hysterectomy, represent a unique challenge due to the amount of microorganisms found at the skin level of the vagina or the endocervix.
However, there is no clear evidence that the complication decreases with the use of postoperative antibiotics.
With the completion of this study, a multicentre triple-blind controlled randomized controlled trial is intended to determine the behavior of the application of this intervention.
Patients who attend an outpatient clinic with benign pathology will be selected, in which indication of laparoscopic hysterectomy, consents are completed and research content is widely explained. Prior to surgery, the sample is taken for a gram of vaginal discharge and in the post-surgical phase delivery of the medication will be performed. Follow-up will be carried out by surgical control and by telephone.
The investigator intend to find that with the prophylaxis not only of presurgical cephalosporin, but with the formulation of metronidazole ovules in the postoperative, the incidence of laparoscopic post-hysterectomy vaginal abscess and cellulitis of cuff is reduced.
Detailed description
The development of the project will be carried out in the facilities of the Prado clinic in the city of Medellín and the Comfamily Clinic in the city of Pereira. Initially to the participants who attend by external consultation for assessment by the laparoscopic gynecology group that are candidates to perform a laparoscopic hysterectomy, they will be given general information about the research in development and its possible participation. Later on the day of surgery in the preparation room and before receiving any medication, The assigned investigator as assistant to the surgery will explain in detail the protocol of the investigation, the commitments acquired by the participant and the possibilities of withdrawal of the same, you will obtain the signature and trace of the informed consent. With the aim of not delaying the 7 am surgical program, a weekly resident will be assigned to inform and fill out the forms of the first patients scheduled for hysterectomy.
Advance by means of a table of random numbers generated in EPIDAT and that is hidden for the researcher. Participants will be assigned to one of the 2 groups, the intervention group will receive the treatment scheme with metronidazole 500mg ovules every 12 hours for 5 days and the control group will receive a placebo.
After this in the surgery room and with the participants under general anesthesia, the sample will be taken for gram of vaginal discharge, previous marking of the plate, with the initials of names and surnames and the patient's identification number, With the use of a speculum and applicator the sample will be taken in the sack bottoms or vaginal walls, which will be sent to the Prolab laboratory in the city of Medellín and the laboratory of the Comfamily clinic in the city of Pereira. for its processing, standardization will be made prior to reading it with the staff of both laboratories.
For the diagnosis of bacterial vaginosis, the Nugent criteria will be used. In this method, the morphotypes corresponding to large Gram-positive bacilli, small Gram-negative bacilli and curved variable Gram bacilli are quantified. And a value is assigned according to the findings. The interpretation of the results is numerical based on the score obtained by adding the crosses of the morphotypes of the bacteria present in the vaginal discharge: 7 or more points are diagnostic of bacterial vaginosis, from 4 to 6 points is considered intermediate and from 0 to 3 is considered normal.
At the end of the surgical procedure, the investigator will complete the completion of Annex 1, will go to the pharmaceutical service where he will request the corresponding product to the patient. The pharmacy staff will verify the assigned number in the randomization table and deliver the medication and the resident will take it to the recovery room with its respective formula.
The assigned investigator will conduct a telephone interview 7 days after the procedure to assess the post-surgical evolution, will be questioned about the presence of symptoms that may be related to an infectious process. Between 10-15 days of the surgical procedure, the gynecologist will perform the post-surgical review in an outpatient clinic to assess the evolution of the patient and re-evaluate the result of the pathology. The Gram result of vaginal discharge, the pathology and the evolution note made by the surgeon will be reviewed with the aim of detecting any diagnosed complication. Finally, 30 days after the procedure, the last telephone follow-up will be performed to detect the presence of any infection. of the operative site.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cephalosporin + Metronidazole | Experimental | Drug: cephalosporin + Metronidazole VaginalIn this arm, patients randomly selected, will receive cephalosporin in doses of 2 grams administered intravenously before surgery. metronidazole vaginal ovules of 500mg twice a day for 5 days after surgery |
| cephalosporin + placebo | Placebo comparator | Drug: cephalosporin + PlacebosIn this arm, patients randomly selected, will receive cephalosporin in doses of 2 grams administered intravenously before surgery. placebo vaginal ovules twice a day for 5 days after surgery |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients between 18 and 55 years old scheduled for laparoscopic hysterectomy for benign pathology in the two centers linked to the study (Clínica del Prado and Pereira community clinic), who have been informed of their participation in the study and who have signed informed consent.
- Patients who are able to communicate by telephone and answer questions
Key exclusion criteria (5 listed)
- Patients who are participating in another study of antibiotic treatment.
- Patients who have a known allergy to imidazole medications.
- Patients with current diagnosis of bacterial vaginosis.
- Patients with current treatment or 30 days prior to surgery for bacterial vaginosis or antibiotic treatment for another pathology.
- Patients who do not reside in Medellín or in its nearby municipalities and can not attend the scheduled evaluation.
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 |
|---|---|---|
| cephalosporin + Metronidazole Vaginaladministration of cephalosporin in doses of 2 grams administered intravenously before surgery and metronidazole vaginal ovules 500mg twice a day for 5 days after performing laparoscopic hysterectomy | Drug | cephalosporin + Metronidazole |
| cephalosporin + Placebosadministration of cephalosporin in doses of 2 grams administered intravenously before surgery and vaginal ovules of placebo twice a day for 5 days after performing laparoscopic hysterectomy | Drug | cephalosporin + placebo |
Primary outcome
Incidence of cellulitis and vaginal cuff abscess
Time frame: 30 days
3 secondary outcomes
percentage of patients who will undergo laparoscopic hysterectomy have bacterial vaginosis at the time of the procedure.
Time frame: 15 days
need to perform additional procedures as part of the treatment in each of the groups.
Time frame: 30 days
percentage of patients who comply with the prescribed treatment completely.
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Results publication: PubMed 19384149ACOG practice bulletin No. 104: antibiotic prophylaxis for gynecologic procedures. Obstet Gynecol. 2009 May;113(5):1180-1189. doi: 10.1097/AOG.0b013e3181a6d011. No abstract available.
- Results publication: PubMed 19104364Lowe NK, Neal JL, Ryan-Wenger NA. Accuracy of the clinical diagnosis of vaginitis compared with a DNA probe laboratory standard. Obstet Gynecol. 2009 Jan;113(1):89-95. doi: 10.1097/AOG.0b013e3181909f63.
- Results publication: PubMed 7361218Brachman PS, Dan BB, Haley RW, Hooton TM, Garner JS, Allen JR. Nosocomial surgical infections: incidence and cost. Surg Clin North Am. 1980 Feb;60(1):15-25. doi: 10.1016/s0039-6109(16)42030-x.
- Results publication: PubMed 8906013Persson E, Bergstrom M, Larsson PG, Moberg P, Platz-Christensen JJ, Schedvins K, Wolner-Hanssen P. Infections after hysterectomy. A prospective nation-wide Swedish study. The Study Group on Infectious Diseases in Obstetrics and Gynecology within the Swedish Society of Obstetrics and Gynecology. Acta Obstet Gynecol Scand. 1996 Sep;75(8):757-61. doi: 10.3109/00016349609065742.
- Results publication: PubMed 19588379Oduyebo OO, Anorlu RI, Ogunsola FT. The effects of antimicrobial therapy on bacterial vaginosis in non-pregnant women. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006055. doi: 10.1002/14651858.CD006055.pub2.
- Results publication: PubMed 10028110Joesoef MR, Schmid GP, Hillier SL. Bacterial vaginosis: review of treatment options and potential clinical indications for therapy. Clin Infect Dis. 1999 Jan;28 Suppl 1:S57-65. doi: 10.1086/514725.
- Results publication: PubMed 12625969Larsson PG, Carlsson B. Does pre- and postoperative metronidazole treatment lower vaginal cuff infection rate after abdominal hysterectomy among women with bacterial vaginosis? Infect Dis Obstet Gynecol. 2002;10(3):133-40. doi: 10.1155/S1064744902000133.
- Results publication: PubMed 1504154Larsson PG. Treatment of bacterial vaginosis. Int J STD AIDS. 1992 Jul-Aug;3(4):239-47. doi: 10.1177/095646249200300402. No abstract available.
- Results publication: PubMed 21944221McElligott KA, Havrilesky LJ, Myers ER. Preoperative screening strategies for bacterial vaginosis prior to elective hysterectomy: a cost comparison study. Am J Obstet Gynecol. 2011 Nov;205(5):500.e1-7. doi: 10.1016/j.ajog.2011.07.012. Epub 2011 Jul 20.
- Results publication: PubMed 15902186Schey D, Salom EM, Papadia A, Penalver M. Extensive fever workup produces low yield in determining infectious etiology. Am J Obstet Gynecol. 2005 May;192(5):1729-34. doi: 10.1016/j.ajog.2004.11.049.
- Results publication: PubMed 11425832Makinen J, Johansson J, Tomas C, Tomas E, Heinonen PK, Laatikainen T, Kauko M, Heikkinen AM, Sjoberg J. Morbidity of 10 110 hysterectomies by type of approach. Hum Reprod. 2001 Jul;16(7):1473-8. doi: 10.1093/humrep/16.7.1473.
- Results publication: PubMed 18954757Faro C, Faro S. Postoperative pelvic infections. Infect Dis Clin North Am. 2008 Dec;22(4):653-663. doi: 10.1016/j.idc.2008.05.005.
- Individual participant dataSharing planned: Yes
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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.
CLAUDIA LOPEZ, Gynecologist principal investigator
CES University - Clínica del prado
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cephalosporin + Metronidazole Vaginal in people with Hysterectomy and Cellulitis, run by CES University at 2 sites in Colombia.
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 5 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Colombia. 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. Some participants in this study may receive a placebo. 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 CLAUDIA LOPEZ, Gynecologist (3104365060, cclopez04@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of cellulitis and vaginal cuff abscess (time frame: 30 days). 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 NCT03917134, which also lists 34 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 16 Apr 2019.