An interventional study of Vitaltape® bandage in Seroma, sponsored by Instituto Nacional de Cancer, Brazil. Completed at 1 site in Brazil. Open to female participants. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by Instituto Nacional de Cancer, Brazil · Not applicable, Interventional, and Treatment
Seroma is the most common complication at the beginning of healing after surgery for breast cancer treatment. Its incidence varies in the literature from 2.5 to 90% and is defined as a collection of serous fluid that develops through skin flaps in the dead space after mastectomy or axillary dissection. The physiopathology for seroma formation has not yet been fully understood, but appears to be multifactorial with surgery being the main factor. Although seroma formation is not a threat to life, it can lead to important morbidity due to associated with necrosis, dehiscence, predisposition to sepsis, reduction of shoulder functions due to muscle weakness due to restriction of movement, prolonging the recovery period and, consequently, leading to delay in adjuvant therapy. The best seroma treatment is still not well defined in the literature and the compressive therapy aims to rebalance fluid exchange between the lymphatic system and blood, having as effects the increase of the interstitial pressure, the improvement of the effectiveness of muscular work, increased resistance of the skin and prevention new collection of interstitial fluid. Recently, the Kinesio® Taping method were inserted into clinical practice for its ability to reduce pain and local swelling. Objective: To evaluate the safety of taping in the seroma after surgical treatment of breast cancer. Methodology: This is a pre and post-clinical application of taping on the seroma in women submitted to surgical treatment for breast cancer in the Cancer Hospital III / INCA. The intervention was performed by applying the compression bandage over the seroma region for an average of five days, when the reassessment was performed.
Patients identified by the nursing team with seroma and with indication of aspiration puncture, will be evaluated for eligibility criteria. Those who agree to participate in the study will be assessed and submitted to the intervention on the same day, they will remain with four days approximately for nursing and physiotherapy revaluation for intervention suspension. The neuromuscular bandage will be applied after skin antisepsis with 70% alcohol. A 5 cm width Vitaltape® neuromuscular bandage will be used. For the bandage application, a distal base (anchor) with two centimeters of diameter will be maintained with maximum stretching on the fluctuation region (seroma) and finalized with another base without stretching, of 2 centimeters, in the proximal region. How many bundles of bandages are required according to the patient's body characteristics and aspect of the flotation region. The bandage will not be applied on the scar. If there are any complications such as itching, redness, discomfort and / or others, the patients will remove the material at home and communicate on return to the institution. The interview will be conducted at the entrance to the study, prior to the intervention and the end of the study. In the initial interview will be collected sociodemographic data and life habits. They will be evaluated by questionnaire as the local symptoms caused by the use of the bandages, the tolerance and feeling / referred sensation during and at the end of intervention period, the percentage of seroma volume alteration before and after the use of the bandage, the number of days of use and bandage detachment. All reviews will be carried out by another professional who will not make the interventions. From the hospital record, information will be collected regarding the oncology treatment, histopathological report and clinical data on curative care.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's enrollment of 35 is below the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →Instituto Nacional de Cancer, Brazil is the lead sponsor of 41 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The neuromuscular bandage will be applied after skin antisepsis with 70% alcohol. A 5 cm width Vitaltape® bandage will be used. For the bandage application, a distal base (anchor) with two centimeters of diameter will be maintained with maximum stretching on the seroma and finalized with another base no stretching, of 2 cm, in the proximal region. How many bundles of bandages are required according to the patient's body characteristics and aspect of the flotation region. The bandage will not be applied on the scar. If there are any complications such as itching, redness, discomfort and / or others, the patients will remove the material at home and communicate on return to the institution. They will remain four days approximately for revaluation and intervention suspension.
Device: Vitaltape® bandage
The neuromuscular bandage will be applied after skin antisepsis with 70% alcohol. A 5 cm width Vitaltape® neuromuscular bandage will be used. For the bandage application, a distal base (anchor) with two centimeters of diameter will be maintained with maximum stretching on the seroma and finalized with another base no stretching, of 2 cm, in the proximal region. How many bundles of bandages are required according to the patient's body characteristics and aspect of the flotation region.
Assess dermal changes of using the compressive bandage as a treatment for seroma
Dermal changes were evaluated at the site of application of the bandage of the 35 participants, such as discoloration, local temperature increase, skin peeling, presence of wound and formation of bullous lesions at the site of application of neuromuscular bandage, graded in mild, moderate or severe , according to the severity of the change, from a semi-structured questionnaire.
Time frame: 4 to 5 days
Seroma volume difference
It was verified from the comparison between the volumes of liquid punctured by nursing punctured by the nursing team on the day of application and on the return of the patient
Time frame: 4 to 5 days
It was evaluated the patient's tolerance to the use of compressive bandages
It was counted how many of the 35 patients felt pain, itching, burning, discomfort, tightness, increased fluctuation (seroma) at the place where the bandage was applied. The symptoms were graded according to the Visual Numeric Scale (0-10), where 0 was considered to be sensations and 10 was unbearable sensation with the use of bandages.
Time frame: 4 to 5 days
It was evaluated the patient satisfaction with the use of compressive bandages
It was evaluated how many of the 35 participants were satisfied with the use of the bandage, being graded according to the Visual Numerical Scale, where 0 was considered totally dissatisfied and 10 was totally satisfied.
Time frame: 4 to 5 days
It was assessed whether the patient felt secure with compressive bandage
It was evaluated how many of the 35 participants felt safe using the bandage. For each participant, safety was graded according to the Visual Numerical Scale, where 0 was considered totally dissatisfied and 10 was completely satisfied.
Time frame: 4 to 5 days
Ran from Jun 2017 to primary completion in Aug 2017, 2 months.
Of 43 non-industry interventional studies with no phase under Seroma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 65. This study's 2 months is below that.
Counting every sponsor, half of 44 studies reached it within 34 months; a quarter within 17 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Cancer, Brazil