Suction Drain Versus the Use of Adaptive Skin Sutures After Mastectomy ± Axillary Lymphadenectomy; a Prospective Randomised Study
This study is currently recruiting participants.
Verified February 2012 by National Institute of Oncology, Hungary
Sponsor:
National Institute of Oncology, Hungary
Information provided by (Responsible Party):
Dr. Zoltan Matrai, National Institute of Oncology, Hungary
ClinicalTrials.gov Identifier:
NCT01509781
First received: January 8, 2012
Last updated: February 8, 2012
Last verified: February 2012
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Purpose
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(Arm: Adaptive suture) following simplex mastectomy or modified radical mastectomy in the light of the total volume of withdrawn serum from wound cavity, the extent of early postoperative analgesic requirements and quality of life.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by National Institute of Oncology, Hungary:
Primary Outcome Measures:
- Total amount of sera withdrawn from the wound cavity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]By each follow-up visit within the indicated time frame, the punctuated serum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.
Secondary Outcome Measures:
- Extent of early postoperative analgesic requirements [ Time Frame: 4 days ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Rate of local wound complications. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Assessment of quality of life in the early postoperative period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]Suction drain, suction flask, syringes, number of patient-doctor consultations
| Estimated Enrollment: | 400 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | up to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509781
Contacts
| Contact: Zoltan Matrai, M.D. | +36 1 224 8600 ext 3302 | matraidoc@gmail.hu |
| Contact: Laszlo Toth, M.D., Ph.D. | toth.l@oncol.hu |
Locations
| Hungary | |
| National Institute of Oncology | Recruiting |
| Budapest, Hungary, 1122 | |
| Contact: Zoltan Matrai, M.D. +3612248600 ext 3302 matraidoc@gmail.com | |
Sponsors and Collaborators
National Institute of Oncology, Hungary
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Dr. Zoltan Matrai, principal investigator, National Institute of Oncology, Hungary |
| ClinicalTrials.gov Identifier: | NCT01509781 History of Changes |
| Other Study ID Numbers: | MRM-987/2011 |
| Study First Received: | January 8, 2012 |
| Last Updated: | February 8, 2012 |
| Health Authority: | Hungary: Pharmaceutical and Healthcare Quality and Organization Development Institute |
Keywords provided by National Institute of Oncology, Hungary:
|
simple mastectomy modified radical mastectomy wound care suction drain adaptive suture |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma in Situ Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 16, 2013