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The objective of this prospective randomized study is to perform qualitative and quantitative comparisons between the insertion of traditional suction drains (Arm: Suction drain) versus the application of absorbable adaptive sutures (Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suction drain | Active Comparator | Patients in Arm A undergo simplex mastectomy or modified radical mastectomy. One plastic Redon drain (16 Ch) is placed after simplex mastectomy and two plastic Redon drains (16 Ch each) following modified radical mastectomy. |
|
| Adaptive suture | Experimental | Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insertion of suction drain(s) following mastectomy | Procedure | One suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of sera withdrawn from the wound cavity | By each follow-up visit within the indicated time frame, the punctuated serum is collected and its volume is measured by a measuring cylinder acquired from the Pharmacy Department and data is recorded. At the end of the follow-up period, the total amount of serum (mL) is documented. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Extent of early postoperative analgesic requirements | Assessment of analgesic consumption to achieve adequate pain relief for each patient. Pain relief is carried out according to institutional protocol and includes: diclofenac sodium, diclofenac sodium + orphenadrine, nalbuphine, metamizole sodium, paracetamole, tramadole. | 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoltan Matrai, M.D. | Contact | +36 1 224 8600 | 3302 | matraidoc@gmail.hu |
| Laszlo Toth, M.D., Ph.D. | Contact | toth.l@oncol.hu |
| Name | Affiliation | Role |
|---|---|---|
| Miklos Kasler, M.D., Ph.D., D.Sc., Prof. | National Institute of Oncology | Principal Investigator |
| Laszlo Toth, M.D., Ph.D., Prof. | National Institute of Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Oncology | Recruiting | Budapest | Budapest | 1122 | Hungary |
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| Adaptive skin sutures. | Procedure | Subcutis of skin flaps of the axilla and the wound edges are adapted to the chest wall and pectoralis major muscle by 8 to 24 stitches (depending on the wound surface of the breast and axilla) using 3.0 absorbable sutures, in a distance of 4-5 cm from each other in a chessboard pattern. The wound is then closed with 3.0 running subcutaneous sutures and 4.0 intracutaneous stitches. Compressive dressing is applied on the chest in the first 12-24 hours after surgery. |
|
| Number of punctions following the removal of suction drain, and total volume of punctuated seroma (mL) |
| 4 weeks |
| Rate of local wound complications. | 4 weeks |
| Assessment of quality of life in the early postoperative period | Using EORTC QoL BR23, weekly for 4 weeks following surgery. | 4 weeks |
| Mobility of the shoulder on the side of the operated side | Assessing shoulder motion on the 1st postoperative day, then weekly for 4 weeks. Abduction 1: 0°- 45° Abduction 2: 45° - 90° Abduction 3: 90° - 135° Abduction 4: 135° - 180° | 4 weeks |
| Cost analysis | Suction drain, suction flask, syringes, number of patient-doctor consultations | 4 weeks |
| Ferenc Renyi Vamos, M.D., Ph.D. |
| National Institute of Oncology |
| Study Chair |
| Akos Savolt, M.D. | National Institute of Oncology | Study Chair |
| Emil Farkas, M.D. | National Institute of Oncology | Study Chair |
| Ildiko Horti, M.D. | National Institute of Oncology | Study Chair |
| Zoltan Matrai, M.D. | National Institute of Oncology | Principal Investigator |
| ID | Term |
|---|---|
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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