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A prospective randomised trial of two treatments for wound seroma after breast surgery
EJSO 2002; 28: 620±622 doi:10.1053/ejso.2002.1298, available online at http://www.idealibrary.com on
1
A prospective randomised trial of two treatments for wound seroma after breast surgery R. Anand, R. Skinner, G. Dennison and J. A. Pain Poole Hospital NHS Trust, Longfleet Road, Poole BH15 2JB, Dorset, UK
Aims: Seroma formation is a recognised complication of breast surgery causing wound pain and discomfort. It was hypothesised that daily aspiration of symptomatic seromas that formed after breast surgery would encourage flap adherence to the chest wall, thereby allowing swifter resolution of seroma. Methods: Thirty-six patients undergoing mastectomy and/or axillary clearance who formed seroma post operatively, were randomised into two groups either having daily aspiration of seroma or aspiration as required by patient symptoms. Results: The daily aspiration required significantly more attendances for aspiration (P , 0.005) and the time from surgery to final aspiration was not reduced. Conclusion: Daily aspiration of symptomatic seroma did not result in swifter resolution. # 2002 Elsevier Science Ltd. All rights reserved. Key words: breast cancer; seroma; aspiration; drains.
INTRODUCTION Wound seroma is the most common complication1 after breast cancer surgery especially where axillary clearance has been performed and has a reported incidence varying from 2.5±51%.1±3 Several factors predisposing to seroma formation have been identified including number of lymph node metastases present,4 type of wound drainage,5,6 and duration of drainage.3,7±9 The optimal way to manage a seroma is unknown as there are no reports of comparative treatments apart from one study,10 which found no advantage of using tetracycline infusion through drains. Most clinicians will aspirate a symptomatic seroma and thereafter only reaspirate if another symptomatic seroma reaccumulates. We have investigated whether a more aggressive policy of daily aspirations might allow a more rapid final resolution. Ethical approval was granted for this study.
MATERIALS AND METHODS Prospective data was collected for 72 consecutive patients undergoing mastectomy alone or mastectomy Correspondence to: Mr J. A. Pain, Poole Hospital NHS Trust, Longfleet Road, Poole BH15 2JB, UK. Tel.: 01202 442951; Fax: 01202 448165; E-mail: [email protected] 0748-7983/02/$35.00
and/or axillary clearance for breast cancer. All wounds were closed by suturing the skin only with 3/0 subcuticular vicryl (Ethicon Ltd, UK) and a simple adhesive dressing was applied (Mepore, Molnlycke, Sweden). All wounds were drained post operatively using a closed suction drain (Redivac, Biomet Ltd, UK) and the drain was only removed once the drainage was less than 75 ml for the preceding 24 h, and in all patients by the 5th postoperative day. Patients were advised of the possibility of developing a wound seroma after drain removal, and were advised to return to the surgical ward if it became symptomatic. Seroma in this study was defined as a symptomatic fluctuant collection in the wound site. Patients were then randomised to undergo either daily aspiration of the seroma until resolution (Group A) or aspiration of seroma as required by patient symptoms (Group B). All patients were routinely reviewed in outpatients at one and six weeks and the presence of seroma noted. Parameters including age, type of operation, length of hospital stay, volume of wound drainage in hospital, tumour size, number of lymph nodes removed and number infiltrated were recorded for each patient. Needle aspirations were undertaken on the surgical ward using an aseptic technique and the frequency and volume of aspirations were noted. The two treatment methods were compared by analysing the difference in the number of #
2002 Elsevier Science Ltd. All rights reserved.
TWO TREATMENTS FOR WOUND SEROMA AFTER BREAST SURGERY
621
were no significant differences in the parameters recorded for each of these groups. Table 2 shows the comparative data for the two treatment groups. As the time of resolution of the seroma in the `as required' group (Group B) was not known it was the time to final aspiration that was compared between the two groups. All seromas had resolved at the six-week outpatient review. There was no significant difference in the time from surgery to final aspiration between Group A (25.4 + 13.4 days) and Group B (20.4 + 5.8 days). However there were a significantly greater number of aspirations (P , 0.005) performed in Group A (10.1 + 6.3 times) compared with Group B (3.3 + 2.2 times). In Group A the total mean volume aspirated per patient (871 + 1045 ml) was more than twice that of Group B (376 + 310 ml) but this did not reach statistical difference.
aspirations, volumes aspirated, length of time from the operation to the final aspiration, the time from removal of the drain to the final aspiration and the time from commencement of aspirations to the final aspiration.
Statistical analysis The difference between the means for each patient group were compared using Student's t-test. The data for, type of operation and number of lymph node metastases were compared using a w2 analysis. A P value , 0.05 was considered significant.
RESULTS One patient developed a wound infection prior to any intervention and required open drainage and so was excluded from the study. Of the remaining 71 patients, 31 did not develop a seroma and four were noted to have an asymptomatic seroma at clinic review 1 week after discharge from hospital. Therefore the 36 patients remaining who developed a symptomatic seroma were randomised to either daily aspirations (Group A) or as required aspirations (Group B). Table 1 shows there
DISCUSSION Reports of seroma incidence after breast surgery vary between 2.5% and 51%,2±4,7 and our study had a 51% incidence of seroma. The wide variation in seroma incidence may in part be due to different subjective
Table 1 Patient data
Number Age (years) Operation Mastectomy Mastectectomy and axillary clearance Axillary clearance Hospital stay (days) Wound drainage prior to discharge (mls) Tumour size (mm) No of removed nodes No of nodes involved
No seroma
Asymptomatic seroma
Daily aspirations
As required aspirations
P
31 58 11
4 63 13
18 59 10
18 66 10
>NS
0 12
0 4
1 8
4 5
>NS >NS
19 4.2 1.5 385 283
0 5.2 1.9 485 236
9 4.5 1.7 311 167
9 4.9 3.1 273 186
>NS >NS >NS
21.5 9.6 13.6 5.9 11
24.2 2.9 15.7 4.0 0
19.0 7.0 13.2 5.8 9
27.0 19.0 10.4 4.7 7
>NS >NS >NS
Table 2 Comparison of the two treatment methods for symptomatic seromas
Number of aspirations Mean total volume of aspirations per patient (mls) Time (days) Operation to final aspiration Drain removal to final aspiration (days) First to final aspiration (days)
`Daily aspirations' Group A
`As required aspirations' Group B
P
10.1 6.3 871 1045
3.3 2.2 376 310
,0.0005 ÿ0.08
25.4 13.4 20.9 13.1 14.9 12.3
20.4 5.8 16.3 5.1 8.5 5.8
.0.05 .0.05 .0.05
622 methods of defining a seroma. There are many factors, which may increase or decrease seroma formation which need to be accounted for when comparing studies. The incidence of seroma may be increased if involved lymph nodes are excised2,4,11 or if the wound is not drained post operatively.5,6 The timing of drain removal remains controversial. Some studies have advocated that the early removal of drains within the first week leads to increased seroma incidence2,3,7 whereas others have shown that removal within five days has no influence.8,9 It has been suggested prolonged drainage may perpetuate the volume drained, as drains can cause tissue inflammation.12 Body mass index appears to be an independent risk factor which has a linear relationship with seroma formation.13 Factors which may reduce the incidence of seroma formation include suturing of the wound flaps or using tissue glue to close the dead space after mastectomy and/or axillary clearance.14±19 Restriction of shoulder movements may also reduce the incidence of seroma formation20,21 although evidence for this is not conclusive.11,22 It was hypothesised that daily aspirations of seromas would keep the wound cavity dry and allow the wound flaps to adhere to the chest wall preventing reaccumulation of fluid, resulting in a more rapid resolution. This hypothesis was not proven as those patients undergoing daily aspiration of symptomatic seroma group required significantly more aspirations without reducing the time from drain removal to final aspiration. Patients randomised to daily aspiration of seroma required greater use of hospital resources with no proven benefit, we therefore conclude seromas should only be aspirated when symptomatic.
REFERENCES 1. Tejler G. Aspegren. Complications and hospital stay after surgery for breast cancer: a prospective study of 385 patients. Br J Surg 1985; 72: 542±4. 2. Barwell J, Campbell I, Watkins RM, Teasdale C. How long should suction drains stay in after breast surgery with axillary dissection. Ann R Coll Surg Engl 1997; 79: 435±7. 3. Woodworth PA, McBoyle MF, Helmer SD, Beamer RL. Seroma formation after breast cancer surgery. American Surgeon 2000; 66: 444±51.
R. ANAND ET AL. 4. Bryant M, Baum M. Postoperative seroma following mastectomy and axillary dissection. Br J Surg 1987; 74: 1187. 5. Somers RG. The use of closed suction drainage after lumpectomy and axillary node dissection for breast cancer. A prospective randomised trial. Ann Surg 1992; 215: 146±9. 6. Cameron AEP, Ebbs SR, Wylie F, Baum M. Suction drainage of the axilla: a prospective randomised trial. Br J Surg 1988; 75: 1211. 7. Gupta R, Patel K, Varshney S, Goddard J, Royle GT. A comparison of 5-day and 8-day drainage following mastectomy and axillary clearance. Eur J Surg Oncol 2001; 27: 26±30. 8. Yii M, Murphy C, Orr N. Early removal of drains and discharge of breast cancer surgery patients: a controlled prospective clinical trial. Ann R Coll Surg Engl 1995; 377±9. 9. Parikh HK, Badwe RA, Ash CM et al. Early drain removal following modified radical mastectomy: a randomised trial. J Surg Onc 1992; 51: 266±9. 10. McCarthy PM. An aborted prospective randomised trial of sclerotherapy for prolonged drainage after mastectomy. Surg Gynae Obstet 1986; 162: 418±20. 11. Petrek JA. Axillary lymphadenectomy. A prospective, randomised trial of 13 factors influencing drainage, including early or delayed arm immobilisation. Arch Surg 1990; 125: 378±82. 12. Tadych K, Donegan WL. Postmastectomy seromas and wound drainage. Surg Gynae Obstet 1987; 165: 483±7. 13. Bonnema J, Van Geel AN, Lichtenstein DA, Schmitz PIM, Wiggers TA. A prospective randomised trial of high versus low vacuum drainage after axillary dissection for breast cancer. Am J Surg 1997; 173: 76±9. 14. Coveney EC, O'Dwyer PJ, Geraghty JG, O'Higgins NJ. Effect of closing dead space on seroma formation after mastectomy ± a prospective randomised clinical trial. Eur J Surg Oncol 1993; 19: 143±6. 15. Chilson TR, Chan FD, Lonser RR et al. Seroma prevention after modified radical mastectomy. Am Surg 1992; 58: 750±4. 16. O'Dwyer PJ, O'Higgins NJ, James AG. Effect of closing dead space on incidence of seroma after mastectomy. Surg Gynae Obstet 1991; 72: 55±6. 17. Moore MM, Nguyen DHD, Spotnitz WD. Fibrin sealant reduces serous drainage and allows for earlier drain removal after axillary dissection: a randomised prospective trial. Am Surg 1996; 63: 97±102. 18. Furrer M, Inderbitzi R, Nachur B. Does administration of fibrin glue prevent development lymphoceles after radical lymphadenectomy? Chirurg 1993; 64: l044±9. 19. Uden P, Aspegren K, Balldin G, Game JP, Larsson SA. Fibrin adhesive in radical mastectomy. Eur J Surg 1993; 159: 263±5. 20. Lotze MT. Early versus delayed shoulder motion following axillary dissection: a randomised prospective study. Ann Surg 1981; 193: 288±95. 21. Dawson I, Stam L, Helinga JM, Kalsbeek HL. Effect of shoulder immobilisation on wound seroma and shoulder dysfunction following modified radical mastectomy: a randomised prospective clinical trial. Br J Surg 1989; 76: 311±12. 22. Jansen RFM, Van Geel AN, De Groot HGW. Immediate versus delayed shoulder excercises after axillary lymph node dissection. Am J Surg 1990; 160: 481±4. Accepted for publication 5 April 2002
1
A prospective randomised trial of two treatments for wound seroma after breast surgery R. Anand, R. Skinner, G. Dennison and J. A. Pain Poole Hospital NHS Trust, Longfleet Road, Poole BH15 2JB, Dorset, UK
Aims: Seroma formation is a recognised complication of breast surgery causing wound pain and discomfort. It was hypothesised that daily aspiration of symptomatic seromas that formed after breast surgery would encourage flap adherence to the chest wall, thereby allowing swifter resolution of seroma. Methods: Thirty-six patients undergoing mastectomy and/or axillary clearance who formed seroma post operatively, were randomised into two groups either having daily aspiration of seroma or aspiration as required by patient symptoms. Results: The daily aspiration required significantly more attendances for aspiration (P , 0.005) and the time from surgery to final aspiration was not reduced. Conclusion: Daily aspiration of symptomatic seroma did not result in swifter resolution. # 2002 Elsevier Science Ltd. All rights reserved. Key words: breast cancer; seroma; aspiration; drains.
INTRODUCTION Wound seroma is the most common complication1 after breast cancer surgery especially where axillary clearance has been performed and has a reported incidence varying from 2.5±51%.1±3 Several factors predisposing to seroma formation have been identified including number of lymph node metastases present,4 type of wound drainage,5,6 and duration of drainage.3,7±9 The optimal way to manage a seroma is unknown as there are no reports of comparative treatments apart from one study,10 which found no advantage of using tetracycline infusion through drains. Most clinicians will aspirate a symptomatic seroma and thereafter only reaspirate if another symptomatic seroma reaccumulates. We have investigated whether a more aggressive policy of daily aspirations might allow a more rapid final resolution. Ethical approval was granted for this study.
MATERIALS AND METHODS Prospective data was collected for 72 consecutive patients undergoing mastectomy alone or mastectomy Correspondence to: Mr J. A. Pain, Poole Hospital NHS Trust, Longfleet Road, Poole BH15 2JB, UK. Tel.: 01202 442951; Fax: 01202 448165; E-mail: [email protected] 0748-7983/02/$35.00
and/or axillary clearance for breast cancer. All wounds were closed by suturing the skin only with 3/0 subcuticular vicryl (Ethicon Ltd, UK) and a simple adhesive dressing was applied (Mepore, Molnlycke, Sweden). All wounds were drained post operatively using a closed suction drain (Redivac, Biomet Ltd, UK) and the drain was only removed once the drainage was less than 75 ml for the preceding 24 h, and in all patients by the 5th postoperative day. Patients were advised of the possibility of developing a wound seroma after drain removal, and were advised to return to the surgical ward if it became symptomatic. Seroma in this study was defined as a symptomatic fluctuant collection in the wound site. Patients were then randomised to undergo either daily aspiration of the seroma until resolution (Group A) or aspiration of seroma as required by patient symptoms (Group B). All patients were routinely reviewed in outpatients at one and six weeks and the presence of seroma noted. Parameters including age, type of operation, length of hospital stay, volume of wound drainage in hospital, tumour size, number of lymph nodes removed and number infiltrated were recorded for each patient. Needle aspirations were undertaken on the surgical ward using an aseptic technique and the frequency and volume of aspirations were noted. The two treatment methods were compared by analysing the difference in the number of #
2002 Elsevier Science Ltd. All rights reserved.
TWO TREATMENTS FOR WOUND SEROMA AFTER BREAST SURGERY
621
were no significant differences in the parameters recorded for each of these groups. Table 2 shows the comparative data for the two treatment groups. As the time of resolution of the seroma in the `as required' group (Group B) was not known it was the time to final aspiration that was compared between the two groups. All seromas had resolved at the six-week outpatient review. There was no significant difference in the time from surgery to final aspiration between Group A (25.4 + 13.4 days) and Group B (20.4 + 5.8 days). However there were a significantly greater number of aspirations (P , 0.005) performed in Group A (10.1 + 6.3 times) compared with Group B (3.3 + 2.2 times). In Group A the total mean volume aspirated per patient (871 + 1045 ml) was more than twice that of Group B (376 + 310 ml) but this did not reach statistical difference.
aspirations, volumes aspirated, length of time from the operation to the final aspiration, the time from removal of the drain to the final aspiration and the time from commencement of aspirations to the final aspiration.
Statistical analysis The difference between the means for each patient group were compared using Student's t-test. The data for, type of operation and number of lymph node metastases were compared using a w2 analysis. A P value , 0.05 was considered significant.
RESULTS One patient developed a wound infection prior to any intervention and required open drainage and so was excluded from the study. Of the remaining 71 patients, 31 did not develop a seroma and four were noted to have an asymptomatic seroma at clinic review 1 week after discharge from hospital. Therefore the 36 patients remaining who developed a symptomatic seroma were randomised to either daily aspirations (Group A) or as required aspirations (Group B). Table 1 shows there
DISCUSSION Reports of seroma incidence after breast surgery vary between 2.5% and 51%,2±4,7 and our study had a 51% incidence of seroma. The wide variation in seroma incidence may in part be due to different subjective
Table 1 Patient data
Number Age (years) Operation Mastectomy Mastectectomy and axillary clearance Axillary clearance Hospital stay (days) Wound drainage prior to discharge (mls) Tumour size (mm) No of removed nodes No of nodes involved
No seroma
Asymptomatic seroma
Daily aspirations
As required aspirations
P
31 58 11
4 63 13
18 59 10
18 66 10
>NS
0 12
0 4
1 8
4 5
>NS >NS
19 4.2 1.5 385 283
0 5.2 1.9 485 236
9 4.5 1.7 311 167
9 4.9 3.1 273 186
>NS >NS >NS
21.5 9.6 13.6 5.9 11
24.2 2.9 15.7 4.0 0
19.0 7.0 13.2 5.8 9
27.0 19.0 10.4 4.7 7
>NS >NS >NS
Table 2 Comparison of the two treatment methods for symptomatic seromas
Number of aspirations Mean total volume of aspirations per patient (mls) Time (days) Operation to final aspiration Drain removal to final aspiration (days) First to final aspiration (days)
`Daily aspirations' Group A
`As required aspirations' Group B
P
10.1 6.3 871 1045
3.3 2.2 376 310
,0.0005 ÿ0.08
25.4 13.4 20.9 13.1 14.9 12.3
20.4 5.8 16.3 5.1 8.5 5.8
.0.05 .0.05 .0.05
622 methods of defining a seroma. There are many factors, which may increase or decrease seroma formation which need to be accounted for when comparing studies. The incidence of seroma may be increased if involved lymph nodes are excised2,4,11 or if the wound is not drained post operatively.5,6 The timing of drain removal remains controversial. Some studies have advocated that the early removal of drains within the first week leads to increased seroma incidence2,3,7 whereas others have shown that removal within five days has no influence.8,9 It has been suggested prolonged drainage may perpetuate the volume drained, as drains can cause tissue inflammation.12 Body mass index appears to be an independent risk factor which has a linear relationship with seroma formation.13 Factors which may reduce the incidence of seroma formation include suturing of the wound flaps or using tissue glue to close the dead space after mastectomy and/or axillary clearance.14±19 Restriction of shoulder movements may also reduce the incidence of seroma formation20,21 although evidence for this is not conclusive.11,22 It was hypothesised that daily aspirations of seromas would keep the wound cavity dry and allow the wound flaps to adhere to the chest wall preventing reaccumulation of fluid, resulting in a more rapid resolution. This hypothesis was not proven as those patients undergoing daily aspiration of symptomatic seroma group required significantly more aspirations without reducing the time from drain removal to final aspiration. Patients randomised to daily aspiration of seroma required greater use of hospital resources with no proven benefit, we therefore conclude seromas should only be aspirated when symptomatic.
REFERENCES 1. Tejler G. Aspegren. Complications and hospital stay after surgery for breast cancer: a prospective study of 385 patients. Br J Surg 1985; 72: 542±4. 2. Barwell J, Campbell I, Watkins RM, Teasdale C. How long should suction drains stay in after breast surgery with axillary dissection. Ann R Coll Surg Engl 1997; 79: 435±7. 3. Woodworth PA, McBoyle MF, Helmer SD, Beamer RL. Seroma formation after breast cancer surgery. American Surgeon 2000; 66: 444±51.
R. ANAND ET AL. 4. Bryant M, Baum M. Postoperative seroma following mastectomy and axillary dissection. Br J Surg 1987; 74: 1187. 5. Somers RG. The use of closed suction drainage after lumpectomy and axillary node dissection for breast cancer. A prospective randomised trial. Ann Surg 1992; 215: 146±9. 6. Cameron AEP, Ebbs SR, Wylie F, Baum M. Suction drainage of the axilla: a prospective randomised trial. Br J Surg 1988; 75: 1211. 7. Gupta R, Patel K, Varshney S, Goddard J, Royle GT. A comparison of 5-day and 8-day drainage following mastectomy and axillary clearance. Eur J Surg Oncol 2001; 27: 26±30. 8. Yii M, Murphy C, Orr N. Early removal of drains and discharge of breast cancer surgery patients: a controlled prospective clinical trial. Ann R Coll Surg Engl 1995; 377±9. 9. Parikh HK, Badwe RA, Ash CM et al. Early drain removal following modified radical mastectomy: a randomised trial. J Surg Onc 1992; 51: 266±9. 10. McCarthy PM. An aborted prospective randomised trial of sclerotherapy for prolonged drainage after mastectomy. Surg Gynae Obstet 1986; 162: 418±20. 11. Petrek JA. Axillary lymphadenectomy. A prospective, randomised trial of 13 factors influencing drainage, including early or delayed arm immobilisation. Arch Surg 1990; 125: 378±82. 12. Tadych K, Donegan WL. Postmastectomy seromas and wound drainage. Surg Gynae Obstet 1987; 165: 483±7. 13. Bonnema J, Van Geel AN, Lichtenstein DA, Schmitz PIM, Wiggers TA. A prospective randomised trial of high versus low vacuum drainage after axillary dissection for breast cancer. Am J Surg 1997; 173: 76±9. 14. Coveney EC, O'Dwyer PJ, Geraghty JG, O'Higgins NJ. Effect of closing dead space on seroma formation after mastectomy ± a prospective randomised clinical trial. Eur J Surg Oncol 1993; 19: 143±6. 15. Chilson TR, Chan FD, Lonser RR et al. Seroma prevention after modified radical mastectomy. Am Surg 1992; 58: 750±4. 16. O'Dwyer PJ, O'Higgins NJ, James AG. Effect of closing dead space on incidence of seroma after mastectomy. Surg Gynae Obstet 1991; 72: 55±6. 17. Moore MM, Nguyen DHD, Spotnitz WD. Fibrin sealant reduces serous drainage and allows for earlier drain removal after axillary dissection: a randomised prospective trial. Am Surg 1996; 63: 97±102. 18. Furrer M, Inderbitzi R, Nachur B. Does administration of fibrin glue prevent development lymphoceles after radical lymphadenectomy? Chirurg 1993; 64: l044±9. 19. Uden P, Aspegren K, Balldin G, Game JP, Larsson SA. Fibrin adhesive in radical mastectomy. Eur J Surg 1993; 159: 263±5. 20. Lotze MT. Early versus delayed shoulder motion following axillary dissection: a randomised prospective study. Ann Surg 1981; 193: 288±95. 21. Dawson I, Stam L, Helinga JM, Kalsbeek HL. Effect of shoulder immobilisation on wound seroma and shoulder dysfunction following modified radical mastectomy: a randomised prospective clinical trial. Br J Surg 1989; 76: 311±12. 22. Jansen RFM, Van Geel AN, De Groot HGW. Immediate versus delayed shoulder excercises after axillary lymph node dissection. Am J Surg 1990; 160: 481±4. Accepted for publication 5 April 2002