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

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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.

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

Conditions
-----------------
in Situ Breast Cancer, Invasive Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Insertion of suction drain(s) following mastectomy
* Procedure: Adaptive skin sutures.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients with primary unilateral, stage 0, I or II, T3N1M0 breast cancer necessitating simple or modified radical mastectomy Exclusion Criteria: age above 75 years and bad general state pregnancy autoimmune disease non-radical excision mastitis carcinomatosis lymphangitis carcinomatosis wound infection necessitating treatment

Ages Eligible for Study
-----------------
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suction drain<br>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<br>* One suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy.<br>|
| Experimental: Adaptive suture<br>Following mastectomy, wound cavity is closed with adaptive skin sutures. No suction drain is inserted. | Procedure: Adaptive skin sutures.<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
simple mastectomy, modified radical mastectomy, wound care, suction drain, adaptive suture