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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.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

National Institute of Oncology, Hungary

principal investigator

Symptoms and General Pathology

Rare Diseases

Melanoma

Seroma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

Wound drain is kept until until a scheduled visit three weeks after the surgery unless the drain produced less than 30 ml/day for two consecutive days, in which case it could be removed earlier.

When the drain produces less than 100 mL over 24 hours, the self-suction bulb is removed and the drain is shortened and drained into a colostomy bag placed around the site of drain insertion. A request is filed with the community nursing system to have a visiting nurse to pull out the drain 1-2 cm per day.

Suction drain either kept for three weeks or gradually pulled out.

Suction drain

This prospective randomized non-inferiority study is designed to compare the rate and severity of complications after axillary and inguinal lymph node dissection in stage III melanoma patients in a study group where the drain is left in place for three weeks and a control group consisting of patients managed according to the standard institutional protocol. Furthermore, variables associated with complications will be examined.

Consecutive stage III melanoma patients 18 years or older referred to our institution for axillary or inguinal lymph node dissection is eligible for inclusion of the study. A bipolar vessel sealing device (LigaSure, Covidien) will be used for dissection in all procedures. All patients will be scheduled for an outpatient visit with an experienced nurse three weeks after the surgery. Any deviation from the normal postoperative course will be recorded in the electronic patient journal. Complications are graded according to the Clavien-Dindo classification. Patients with complications or with suspected complications at the three-week follow up will be scheduled for new an outpatient visit. Patient demographics, clinicopathological characteristics of the primary melanoma, indication for the procedure, length of postoperative stay and early complications and treatment for complications will be collected for analysis

Early Complications After Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients

Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients: A Prospective Randomized Trial of Two Approaches to Wound Drainage

To determine if the study group was non-inferior to the control group

Frequency of each complication and an analysis of possible risk factors.

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
Early Complications After Axillary and Inguinal Lymph Node Dissection in Stage III Melanoma Patients	NCT04680182	Melanoma Complication	Suction drain	18 Years -	Oslo University Hospital

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