Wounds and Injuries

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Carcinoma In Situ

Carcinoma

Carcinoma in Situ

Breast Diseases

Skin Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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.

Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted.

One suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy.

Insertion of suction drain(s) following 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.

Adaptive skin sutures.

Zoltan Matrai, M.D.

Laszlo Toth, M.D., Ph.D.

Miklos Kasler, M.D., Ph.D., D.Sc., Prof.

Laszlo Toth, M.D., Ph.D., Prof.

Ferenc Renyi Vamos, M.D., Ph.D.

Akos Savolt, M.D.

Emil Farkas, M.D.

Ildiko Horti, M.D.

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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study

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

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.

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.

Using EORTC QoL BR23, weekly for 4 weeks following surgery.

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°

Suction drain, suction flask, syringes, number of patient-doctor consultations

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study	NCT01509781	in Situ Breast ... Invasive Breast...	Insertion of su... Adaptive skin s...	- 75 Years	National Institute of Oncology, Hungary
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study	NCT01509781	in Situ Breast ... Invasive Breast...	Insertion of su... Adaptive skin s...	- 75 Years	National Institute of Oncology, Hungary
Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study	NCT01509781	in Situ Breast ... Invasive Breast...	Insertion of su... Adaptive skin s...	- 75 Years	National Institute of Oncology, Hungary

Spots Global Cancer Trial Database for insertion of suction drain(s) following mastectomy