Effect of Quilting Sutures on Post-operative Drainage After Mastectomy and/or Axillary Lymph Node Dissection

Breast Cancer Female Clinical Trial

— Quilting  

Official title:

Effect of Quilting Sutures on Post-operative Drainage After Mastectomy and/or Axillary Lymph Node Dissection in Patients With Breast Cancer: a Single Blind Randomised Phase III Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03902977
• Other study ID #: BZ01/17
• Secondary ID: 17-17-F
• Status: Terminated
• Phase: N/A
• Start date: February 19, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: October 2020
• Source: Lindenhofgruppe AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Breast cancer is the most frequent type of cancer among Swiss women (5'700 cases diagnosed every year). Mastectomy is indicated when breast conservative surgery is not possible or by patient wish. Axillary lymph nodes dissection (ALND) is indicated primarily for node-positive breast cancer.

Postoperative seroma after mastectomy and axillary clearance is a common complication, occurring in 25 to more than 60% of patients with breast cancer. After mastectomy and/or ALND conventional wound closure commonly uses suction drain to prevent seroma. However, seroma frequently occurs after drain removal. Excessive fluid accumulation in seroma stretches the skin, resulting in patient discomfort, impaired ipsilateral shoulder function and higher risk of surgical site infection and prolongs the hospitalization. In rare cases, a fibrous encapsulated seroma is resistant to conservative treatment and requires surgical resection. Thus, seroma may also impact health care costs requiring longer hospital stay or unplanned outpatient visits and may delay adjuvant therapy.

Recent data suggest that quilting suture through flap fixation reduces the incidence of seroma. Therefore, quilting suture has the potential to increase patients' quality of life, as well as to shorten the length of hospital stay and to reduce hospital costs, providing the rationale for this study.The aim of our project is to compare the efficacy of quilting suture with that of conventional closure without quilting in reducing the drainage quantity, the length of hospitalisation and the prevalence of seroma following mastectomy and/or axilla for breast cancer, as well as the patient reported pain increasing patient quality of life.

The final goal is the omission of axillary drainage in the future. All randomised patients will be followed for 12 weeks. Patients will fill in 2 questionnaires (EQ5-D: European Quality of Life and Brief Pain Inventory: BPI). The Health Economic Analysis form (HEA) will be completed by the investigator collecting the patient data.

Total duration of study: 2.5 years. There are 2 treatments groups 50% of the study participants will be treated with quilting suture and 50% with conventional closure. Patients are randomly divided into the 2 groups. All patients are blinded to the surgical treatment.This means that they do not know which surgical treatment they have received (quilting suture or conventional closure), The operating surgeon will not see the after the operation. Seroma assessment will be performed by other medical personnel, that do not know which surgical treatment has been given. In case of seroma a physician (not the operating surgeon) will perform the aspiration of seroma if needed.

Description:

Breast cancer is the most frequent type of cancer among Swiss women (5'700 cases diagnosed every year). Mastectomy is indicated when breast conservative surgery is not possible or by patient wish. Axillary lymph nodes dissection (ALND) is indicated primarily for node-positive breast cancer.

Postoperative seroma after mastectomy and axillary clearance is a common complication, occurring in 25 to more than 60% of patients with breast cancer. After mastectomy and/or ALND conventional wound closure commonly uses suction drain to prevent seroma. However, seroma frequently occurs after drain removal. Excessive fluid accumulation in seroma stretches the skin, resulting in patient discomfort, impaired ipsilateral shoulder function and higher risk of surgical site infection and prolongs the hospitalisation. In rare cases, a fibrous encapsulated seroma is resistant to conservative treatment and requires surgical resection. Thus, seroma may also impact health care costs requiring longer hospital stay or unplanned outpatient visits and may delay adjuvant therapy.

Recent data suggest that quilting suture through flap fixation reduces the incidence of seroma. Therefore, quilting suture has the potential to increase patients' quality of life, as well as to shorten the length of hospital stay and to reduce hospital costs The aim of this trial is to compare the efficacy of quilting suture of the dead space at the pectoral area and/or axilla with that of conventional suture in reducing the total volume of post-mastectomy and/or axillary drainage and seroma in female patients after surgical treatment of breast cancer.The study seeks primarily to determine if quilting suture compared to conventional suture after mastectomy/ALND reduces the total volume of axillary drainage until drain removal.

This single blind randomised phase III controlled superiority trial compares 2 surgical techniques: quilting suture and conventional suture. Patients will be assigned to one of 2 parallel groups: Arm A: quilting suture and Arm B: (no quilting suture): conventional wound closure.

Duration of accrual: 2 years - Duration of trial treatment: 1 day (surgery). Surgery procedure: Mastectomies or ALND dissections using a standardized technique, with multiple quilting sutures in the site of the mastectomy/in the dissected axilla or conventional closure without quilting. In both procedures placement of one drain into the breast and axilla or in the axillary cavity.

All randomised patients will be followed for 12 weeks. Patients will fill in 2 questionnaires (Quality of Life: EQ5-D and Brief Pain Inventory: BPI). The Health Economic Analysis form (HEA) will be completed by the investigator collecting the patient data.

At the study visits the following examinations will be performed: physical examination, blinded assessment of seroma, axillary drain volume, adverse events and surgical site infections.

The sample size is based on the primary endpoint, the total volume of axillary drainage. We assume a reduction in the total volume of axillary drainage of 200 ml in the intervention arm (application of quilting sutures) compared to the control arm (no application of sutures), which is based on literature and actual measurements in 14 patients. A total of 106 patients (53 in each group) will yield a power of 80% to detect this difference at a two-sided significance level of 0.05.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years-old female patients

• mastectomy alone, mastectomy and sentinel, mastectomy and axilla, axilla and tumorectomy or axilla alone

• patients with histo- or cytology proven breast cancer Union for International Cancer Control's (UICC)/American Joint Committee on Cancer (AJCC) stage I-III

• Fluency in either German or French

• The EQ-5D and BPI questionnaires must be completed by the patient at registration

• Patient has given written informed consent before registration.

Exclusion Criteria:

• Bilateral operation or reconstruction

• Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent and/or filling out the questionnaires

• Pregnancy.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Procedure:
• quilting
After mastectomies or ALND dissections using standard technique for wound closure multiple sutures (monocryl 3.0) every 3 to 4 cm in the site of the mastectomy (1 or 2 rows) or in the dissected axilla.Placement of one drain into the breast and axilla or in the axillary cavity by a separate stab incision
• conventional suture
After mastectomies or ALND dissections standard technique for wound closure. Placement of one drain into the breast and axilla or in the axillary cavity by a separate stab incision

Locations

Country	Name	City	State
Switzerland	Brustzentrum Bern	Bern

Sponsors (3)

Lead Sponsor	Collaborator
Lindenhofgruppe AG	StiftungLindenhof, University of Bern

Country where clinical trial is conducted

Switzerland, 

References & Publications (34)

Aitken DR, Hunsaker R, James AG. Prevention of seromas following mastectomy and axillary dissection. Surg Gynecol Obstet. 1984 Apr;158(4):327-30. — View Citation

Aitken DR, Minton JP. Complications associated with mastectomy. Surg Clin North Am. 1983 Dec;63(6):1331-52. Review. — View Citation

Barton A, Blitz M, Callahan D, Yakimets W, Adams D, Dabbs K. Early removal of postmastectomy drains is not beneficial: results from a halted randomized controlled trial. Am J Surg. 2006 May;191(5):652-6. — View Citation

Boostrom SY, Throckmorton AD, Boughey JC, Holifield AC, Zakaria S, Hoskin TL, Degnim AC. Incidence of clinically significant seroma after breast and axillary surgery. J Am Coll Surg. 2009 Jan;208(1):148-50. doi: 10.1016/j.jamcollsurg.2008.08.029. Epub 200 — View Citation

Bryant M, Baum M. Postoperative seroma following mastectomy and axillary dissection. Br J Surg. 1987 Dec;74(12):1187. — View Citation

Burak WE Jr, Goodman PS, Young DC, Farrar WB. Seroma formation following axillary dissection for breast cancer: risk factors and lack of influence of bovine thrombin. J Surg Oncol. 1997 Jan;64(1):27-31. — View Citation

Chilson TR, Chan FD, Lonser RR, Wu TM, Aitken DR. Seroma prevention after modified radical mastectomy. Am Surg. 1992 Dec;58(12):750-4. — View Citation

Coveney EC, O'Dwyer PJ, Geraghty JG, O'Higgins NJ. Effect of closing dead space on seroma formation after mastectomy--a prospective randomized clinical trial. Eur J Surg Oncol. 1993 Apr;19(2):143-6. — View Citation

Gauthier T, Garuchet-Bigot A, Marin B, Mollard J, Loum O, Fermeaux V, Jammet I, Kanoun D, Maubon A, Aubard Y. Lanreotide Autogel 90 mg and lymphorrhea prevention after axillary node dissection in breast cancer: a phase III double blind, randomized, placeb — View Citation

Gonzalez EA, Saltzstein EC, Riedner CS, Nelson BK. Seroma formation following breast cancer surgery. Breast J. 2003 Sep-Oct;9(5):385-8. — View Citation

Hashemi E, Kaviani A, Najafi M, Ebrahimi M, Hooshmand H, Montazeri A. Seroma formation after surgery for breast cancer. World J Surg Oncol. 2004 Dec 9;2:44. — View Citation

Jain PK, Sowdi R, Anderson AD, MacFie J. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Br J Surg. 2004 Jan;91(1):54-60. — View Citation

Jeffrey SS, Goodson WH 3rd, Ikeda DM, Birdwell RL, Bogetz MS. Axillary lymphadenectomy for breast cancer without axillary drainage. Arch Surg. 1995 Aug;130(8):909-12; discussion 912-3. — View Citation

Kopelman D, Klemm O, Bahous H, Klein R, Krausz M, Hashmonai M. Postoperative suction drainage of the axilla: for how long? Prospective randomised trial. Eur J Surg. 1999 Feb;165(2):117-20; discussion 121-2. — View Citation

Kumar S, Lal B, Misra MC. Post-mastectomy seroma: a new look into the aetiology of an old problem. J R Coll Surg Edinb. 1995 Oct;40(5):292-4. — View Citation

Kuroi K, Shimozuma K, Taguchi T, Imai H, Yamashiro H, Ohsumi S, Saito S. Effect of mechanical closure of dead space on seroma formation after breast surgery. Breast Cancer. 2006;13(3):260-5. Review. — View Citation

Kuroi K, Shimozuma K, Taguchi T, Imai H, Yamashiro H, Ohsumi S, Saito S. Pathophysiology of seroma in breast cancer. Breast Cancer. 2005;12(4):288-93. Review. — View Citation

Lumachi F, Brandes AA, Burelli P, Basso SM, Iacobone M, Ermani M. Seroma prevention following axillary dissection in patients with breast cancer by using ultrasound scissors: a prospective clinical study. Eur J Surg Oncol. 2004 Jun;30(5):526-30. — View Citation

Medl M, Mayerhofer K, Peters-Engl C, Mahrhofer P, Huber S, Buxbaum P, Sevelda P, Leodolter S. The application of fibrin glue after axillary lymphadenectomy in the surgical treatment of human breast cancer. Anticancer Res. 1995 Nov-Dec;15(6B):2843-5. — View Citation

Ouldamer L, Caille A, Giraudeau B, Body G. Quilting Suture of Mastectomy Dead Space Compared with Conventional Closure with Drain. Ann Surg Oncol. 2015 Dec;22(13):4233-40. doi: 10.1245/s10434-015-4511-6. Epub 2015 Mar 18. — View Citation

Ouldamer L, Trefoux-Bourdet A, Duquesne M, Body G. [How I do … quilting suture of dead space after mastectomy]. Gynecol Obstet Fertil. 2011 Nov;39(11):663-4. doi: 10.1016/j.gyobfe.2011.07.050. Epub 2011 Oct 13. French. — View Citation

Pogson CJ, Adwani A, Ebbs SR. Seroma following breast cancer surgery. Eur J Surg Oncol. 2003 Nov;29(9):711-7. Review. — View Citation

Porter KA, O'Connor S, Rimm E, Lopez M. Electrocautery as a factor in seroma formation following mastectomy. Am J Surg. 1998 Jul;176(1):8-11. — View Citation

Rice DC, Morris SM, Sarr MG, Farnell MB, van Heerden JA, Grant CS, Rowland CM, Ilstrup DM, Donohue JH. Intraoperative topical tetracycline sclerotherapy following mastectomy: a prospective, randomized trial. J Surg Oncol. 2000 Apr;73(4):224-7. — View Citation

Sakkary MA. The value of mastectomy flap fixation in reducing fluid drainage and seroma formation in breast cancer patients. World J Surg Oncol. 2012 Jan 11;10:8. doi: 10.1186/1477-7819-10-8. — View Citation

Sampathraju S, Rodrigues G. Seroma formation after mastectomy: pathogenesis and prevention. Indian J Surg Oncol. 2010 Dec;1(4):328-33. doi: 10.1007/s13193-011-0067-5. Epub 2011 Apr 2. — View Citation

Sanders RP, Goodman NC, Amiss LR Jr, Pierce RA, Moore MM, Marx G, Morgan RF, Spotnitz WD. Effect of fibrinogen and thrombin concentrations on mastectomy seroma prevention. J Surg Res. 1996 Feb 15;61(1):65-70. — View Citation

Schuijtvlot M, Sahu AK, Cawthorn SJ. A prospective audit of the use of a buttress suture to reduce seroma formation following axillary node dissection without drains. Breast. 2002 Feb;11(1):94-6. — View Citation

Shamley DR, Barker K, Simonite V, Beardshaw A. Delayed versus immediate exercises following surgery for breast cancer: a systematic review. Breast Cancer Res Treat. 2005 Apr;90(3):263-71. Review. — View Citation

Soon PS, Clark J, Magarey CJ. Seroma formation after axillary lymphadenectomy with and without the use of drains. Breast. 2005 Apr;14(2):103-7. — View Citation

Tadych K, Donegan WL. Postmastectomy seromas and wound drainage. Surg Gynecol Obstet. 1987 Dec;165(6):483-7. — View Citation

Tejler G, Aspegren K. Complications and hospital stay after surgery for breast cancer: a prospective study of 385 patients. Br J Surg. 1985 Jul;72(7):542-4. — View Citation

ten Wolde B, van den Wildenberg FJ, Keemers-Gels ME, Polat F, Strobbe LJ. Quilting prevents seroma formation following breast cancer surgery: closing the dead space by quilting prevents seroma following axillary lymph node dissection and mastectomy. Ann S — View Citation

van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17. Review. — View Citation

* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient self-reported pain will be assessed with the Brief Pain Inventory (BPI) patient self-reported questionnaire	This questionnaire is a well validated and commonly used self-report measure to assess the severity of pain and the interference of pain with daily activities as well as the quality of life, patient's subjective experience of disease and treatment. The BPI assesses pain at its "worst," "least," "average," and "now" (current pain) on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) during the past 24 hours A clinically meaningful change in worst pain is defined as a change from baseline of at least 2 points in either direction. The BPI measures how much pain has interfered general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is typically scored as the mean of the seven interference items. This mean can be used if more than 50% or four of seven of the total items have been completed on a given administration.	every day during the first 2 weeks after the operation and at week 4 and 12 after surgery
Other	Patient Euro quality of life questionnaire (EQ-5D)	EuroQol Group developed the questionnaire to describe and value health-related quality of life patient's subjective experience of disease and treatment. This includes 5 assessments: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each assessment has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient ticks the box against the most appropriate statement in each of the 5 dimensions, which are summed in a 5-digit number describing the respondent's health state: having no problems for 1, slight problems for 2, moderate problems for 3, severe problems for 4 and extreme problems for 5.; On the form there is also a scale with numbers from 0 to 100. 100 is the best health and 0 the worst health the patient can imagine. The patient has to tick the appropriate number.	every day during the first 2 weeks after the operation and at week 4 and 12 after surgery
Other	Health Economic Analysis (HEA)	forms are completed by the investigator and collect data on hospitalizations, rehabilitation, stays at nursing homes, out-patient visits performed by physicians working at practice offices or at hospitals, treatments as physiotherapy,nutrition counseling or alternative therapies	at week 4 and week 12
Primary	Total volume (ml) of axillary/breast drainage until drain removal.	Blinded daily measurement of axillary drainage volume during hospital stay at 8.00 h a.m in the morning through nurses.	up to 5 days
Secondary	Total duration (days) of breast/axillary drainage	calculated from the date of surgery to date of drain removal calculated drainage from the date of surgery to the date of axillary/breast drain removal	1-5 days
Secondary	Duration of postoperative hospital stay	calculated from the date of surgery to the date of discharge (after surgery patients are hospitalized usually for 5 days)	5-7 days
Secondary	Number of patients with clinically relevant seroma	Clinically relevant seroma is defined as either causing strong discomfort or requiring aspiration	From the date of surgery until 12 weeks after surgery
Secondary	Number of patients with lymphedema	increase of more than 2.5 cm in arm circumference	From the date of surgery until week 12
Secondary	Adverse Events (AEs) due to surgical procedure	after surgery possible wound-related complications (e.g. haematoma requiring reoperation, skin flap necrosis) flap necrosis)	during 4 weeks after surgery
Secondary	Surgical morbidity	number of outpatient visits (related to mastectomy/ALND) needed following participant's discharge	within the 12 weeks follow up after surgery
Secondary	Duration (number of days) of clinically relevant seroma aspiration period	calculated until the date of the last clinically relevant seroma aspiration	from the date of surgery until 12 weeks after surgery
Secondary	Volume of axillary drainage per 24 hours in ml	calculated as the total volume of axillary drainage in ml until drain removal divided by the total duration of axillary drainage in days	up to 5 days
Secondary	Number of clinically relevant seroma aspirations	Aspiration is performed if the patient experiences strong discomfort, in case of impaired ipsilateral shoulder function, if higher risk of surgical infection and in case pain interferences with daily functions	From the date of surgery until 12 weeks after surgery
Secondary	Total volume in ml of all clinically relevant seroma aspirations	calculated in in ml	From the date of surgery until 12 weeks after surgery
Secondary	Surgical morbidity	intraoperative blood loss calculated in ml from start to end of surgery	up to 2 hours
Secondary	Surgical morbidity	duration of the surgical procedure from start to end of surgery	up to 2 hours