Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study
|ClinicalTrials.gov Identifier: NCT01509781|
Recruitment Status : Unknown
Verified October 2015 by Dr. Zoltan Matrai, National Institute of Oncology, Hungary.
Recruitment status was: Recruiting
First Posted : January 13, 2012
Last Update Posted : October 6, 2015
|Condition or disease||Intervention/treatment||Phase|
|in Situ Breast Cancer Invasive Breast Cancer||Procedure: Insertion of suction drain(s) following mastectomy Procedure: Adaptive skin sutures.||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Optimal Wound Care After Simplex or Modified Radical Mastectomy With or Without Axillary Lymphadenectomy Placement of a Drain Versus the Use of Adaptive Skin Sutures; a Prospective Randomised Study|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||January 2016|
Active Comparator: Suction drain
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
One suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy.
Experimental: Adaptive suture
Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted.
Procedure: Adaptive skin sutures.
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- Total amount of sera withdrawn from the wound cavity [ Time Frame: 4 weeks ]By each follow-up visit within the indicated time frame, the punctuated serum is collected and its volume is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.
- Extent of early postoperative analgesic requirements [ Time Frame: 4 days ]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.
- 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 [ Time Frame: 4 weeks ]Using EORTC QoL BR23, weekly for 4 weeks following surgery.
- Mobility of the shoulder on the side of the operated side [ Time Frame: 4 weeks ]
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°
- Cost analysis [ Time Frame: 4 weeks ]Suction drain, suction flask, syringes, number of patient-doctor consultations
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509781
|Contact: Zoltan Matrai, M.D.||+36 1 224 8600 ext email@example.com|
|Contact: Laszlo Toth, M.D., Ph.D.||firstname.lastname@example.org|
|National Institute of Oncology||Recruiting|
|Budapest, Hungary, 1122|
|Contact: Zoltan Matrai, M.D. +3612248600 ext 3302 email@example.com|
|Principal Investigator:||Miklos Kasler, M.D., Ph.D., D.Sc., Prof.||National Institute of Oncology|
|Study Chair:||Laszlo Toth, M.D., Ph.D., Prof.||National Institute of Oncology|
|Study Chair:||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|
|Principal Investigator:||Zoltan Matrai, M.D.||National Institute of Oncology|