A Phase 3 interventional study of Insertion of suction drain(s) following mastectomy and Adaptive skin sutures. in in Situ Breast Cancer and Invasive Breast Cancer, sponsored by National Institute of Oncology, Hungary. Status unknown at 1 site in Hungary. Open to female participants aged Up to 75 Years. Per ClinicalTrials.gov, last updated 2015-10-06.
Sponsored by National Institute of Oncology, Hungary · Phase 3, Interventional, and Health services research
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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 400 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →National Institute of Oncology, Hungary is the lead sponsor of 10 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Insertion of suction drain(s) following mastectomy
Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted.
Procedure: Adaptive skin sutures.
One suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy.
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.
Total amount of sera withdrawn from the wound cavity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.
Time frame: 4 weeks
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.
Time frame: 4 days
Number of punctions following the removal of suction drain, and total volume of punctuated seroma (mL)
Time frame: 4 weeks
Rate of local wound complications.
Time frame: 4 weeks
Assessment of quality of life in the early postoperative period
Using EORTC QoL BR23, weekly for 4 weeks following surgery.
Time frame: 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°
Time frame: 4 weeks
Cost analysis
Suction drain, suction flask, syringes, number of patient-doctor consultations
Time frame: 4 weeks
This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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National Institute of Oncology, Hungary