EdemaNCT05534308
Effect of Intraoperative Taping on the Control of Edema Resulting From Stripping
A study testing Transoperative taping and No trasoperative taping in people with Edema and Varices; Cord, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of the study is to evaluate the effects of the Contensive Taping technique on the control of edema of patients submitted to Phleboextraction Surgery including Saphenectomy. Read more about this study
- Who is it for?
- Ages 25 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Edema, Varices; Cord
- What is being tested?
- Transoperative taping and No trasoperative taping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2022to 20 Dec 2024
- 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 25 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- young adults, aged from 25 to 59 years old, submitted to stripping and saphenectomy.
Who cannot join
- allergies
- skin lesions
- ulcers.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Medical School of Ribeirão Preto
Ribeirão Preto, São Paulo, 14049-900
About this study
The aim of the study is to evaluate the effects of the Contensive Taping technique on the control of edema of patients submitted to Phleboextraction Surgery including Saphenectomy.
Read the detailed description
Edema is a common complication after stripping surgery, so measures that can help the resolution of the condition are important for the recovery in the post operative. The aim of the study is to evaluate the effects of the Contensive Taping technique on the control of edema of patients submitted to phleboextraction surgery including saphenectomy. Therefore, 60 patients of both sexes will be invited to participate in the study, undergoing saphenectomy surgery, divided into two homogeneous groups, determined by the sample calculation. The intervention group (IG) will be composed of patients undergoing phleboextraction with saphenectomy and intervention with contensive taping, in intraoperative period associated with compression with elastic stockings. The control group (CG) will be composed of patients undergoing the same surgical procedure, and standard treatment consisting only of compression by elastic stockings. The procedures for evaluation will be applied before and after seven days of therapeutic intervention. For data analysis, the normality test will be performed and distribution, in addition to a suitable statistical test for the appropriate intra and intergroups, with a significance level of 5%.
- Conditions
- Edema, Varices; Cord
- Being tested
- Transoperative taping, No trasoperative taping
- Keywords
- Functional Bandages, Edema, Ultrasound, Varices
- Medical subject headings
- Edema, Varicose Veins, Cone-Rod Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transoperative tapingProcedure or surgery
The intervention group (IG) will be composed of patients undergoing phleboextraction with saphenectomy and intervention with contensive taping, on intraoperative period associated with compression with elastic stockings.
No trasoperative tapingOther
Patients will received only compression stockings after surgery
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control group (CG) will be composed of patients undergoing the same surgical procedure, and standard treatment consisting only of compression compression by elastic stockings. Receives: Other: No trasoperative taping |
| Intervention Group | Experimental | The intervention group (IG) will be composed of patients undergoing phleboextraction with saphenectomy and intervention with contensive taping, in the period intraoperative associated with compression with elastic stockings. Receives: Procedure: Transoperative taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edema
Perimetry (cm)
Measured: 7 days
Dieletric constant
MoistureMeterD
Measured: 7 days
Secondary outcomes (4)
Elasticity
ElastiMeterD
Measured: 7 days
Pain after surgery
Visual Analogue Scale (VAS)
Measured: 7 days
Functionality of Lower Limbs
Lower Extremity Functional Scale (LEFS)
Measured: 7 days
Tissue stiffness
Elastography
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EdemaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Caldeira de Oliveira Guirro, University of Sao Paulo
- Investigators
- Elaine CO Guirro, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534308
- Sponsor's protocol ID
- 12241
- Status last verified
- Sep 2022
- First submitted
- 9 Jun 2022
- Last updated
- 9 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After the end of Research
Publications
Tatli U, Benlidayi IC, Salimov F, Guzel R. Effectiveness of kinesio taping on postoperative morbidity after impacted mandibular third molar surgery: a prospective, randomized, placebo-controlled clinical study. J Appl Oral Sci. 2020;28:e20200159. doi: 10.1590/1678-7757-2020-0159. Epub 2020 Jul 13.
PubMed 32667383
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Taping on the Control of Edema Resulting From Stripping
- ClinicalTrials.gov ID
- NCT05534308
- Acronym / sponsor ID
- 12241
- Conditions
- Edema, Varices; Cord
- Keywords
- Functional Bandages, Edema, Ultrasound, Varices
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 9 Sep 2022 (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.
The aim of the study is to evaluate the effects of the Contensive Taping technique on the control of edema of patients submitted to Phleboextraction Surgery including Saphenectomy.
Detailed description
Edema is a common complication after stripping surgery, so measures that can help the resolution of the condition are important for the recovery in the post operative. The aim of the study is to evaluate the effects of the Contensive Taping technique on the control of edema of patients submitted to phleboextraction surgery including saphenectomy. Therefore, 60 patients of both sexes will be invited to participate in the study, undergoing saphenectomy surgery, divided into two homogeneous groups, determined by the sample calculation. The intervention group (IG) will be composed of patients undergoing phleboextraction with saphenectomy and intervention with contensive taping, in intraoperative period associated with compression with elastic stockings. The control group (CG) will be composed of patients undergoing the same surgical procedure, and standard treatment consisting only of compression by elastic stockings. The procedures for evaluation will be applied before and after seven days of therapeutic intervention. For data analysis, the normality test will be performed and distribution, in addition to a suitable statistical test for the appropriate intra and intergroups, with a significance level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: No trasoperative tapingThe control group (CG) will be composed of patients undergoing the same surgical procedure, and standard treatment consisting only of compression compression by elastic stockings. |
| Intervention Group | Experimental | Procedure: Transoperative tapingThe intervention group (IG) will be composed of patients undergoing phleboextraction with saphenectomy and intervention with contensive taping, in the period intraoperative associated with compression with elastic stockings. |
Who may qualify
- Ages
- 25 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- young adults, aged from 25 to 59 years old, submitted to stripping and saphenectomy.
Key exclusion criteria (3 listed)
- allergies
- skin lesions
- ulcers.
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 |
|---|---|---|
| Transoperative tapingThe intervention group (IG) will be composed of patients undergoing phleboextraction with saphenectomy and intervention with contensive taping, on intraoperative period associated with compression with elastic stockings. | Procedure or surgery | Intervention Group |
| No trasoperative tapingPatients will received only compression stockings after surgery | Other | Control Group |
Primary outcome
Edema
Time frame: 7 days
Perimetry (cm)
Dieletric constant
Time frame: 7 days
MoistureMeterD
4 secondary outcomes
Elasticity
Time frame: 7 days
Pain after surgery
Time frame: 7 days
Functionality of Lower Limbs
Time frame: 7 days
Tissue stiffness
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2022.
- Results publication: PubMed 32667383Tatli U, Benlidayi IC, Salimov F, Guzel R. Effectiveness of kinesio taping on postoperative morbidity after impacted mandibular third molar surgery: a prospective, randomized, placebo-controlled clinical study. J Appl Oral Sci. 2020;28:e20200159. doi: 10.1590/1678-7757-2020-0159. Epub 2020 Jul 13.
- Individual participant dataSharing planned: No. After the end of Research
Related trials for Edema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
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.
Elaine CO Guirro, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transoperative taping and No trasoperative taping in people with Edema and Varices; Cord, run by University of Sao Paulo at 1 site in Brazil.
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 3 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 9 Sep 2022. 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 Brazil. 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 Elaine CO Guirro, PhD ((16) 3315-4584 ext. 4413, ecguirro@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edema (time frame: 7 days). The study lists 2 primary outcomes in all. 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 NCT05534308, which also lists 1 linked publication.
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 9 Sep 2022.