European Journal of Cardiovascular Medicine

Breast cancer ranks as the second foremost cause of cancer mortality in women. The preferred surgical intervention for these patients is either modified radical mastectomy or breast conservation, contingent upon the disease stage. Seroma formation is the most prevalent postoperative complication following breast cancer surgery. It manifests in the majority of patients post-mastectomy and is increasingly regarded as a side effect of the procedure rather than a complication; however, not all patients exhibit clinical symptoms [1].

Defects in the soft tissues of the head and neck frequently arise from the excision of tumors or trauma to the region. It results in aesthetic and functional impairments, profoundly affecting the patient's quality of life compared to other regions of the body. The reconstruction of this area is essential for preserving functionality and reinstating self-deception. [2]The functional outcome is assessed by gastrointestinal integrity and nonverbal communication via facial expressions. Attaining cosmetically and functionally acceptable outcomes necessitates a collaborative effort among oncologists, reconstructive surgeons, and skilled nursing personnel. Regional pedicle flaps and free flaps serve as reconstruction alternatives. A meticulous and methodical examination of the available reconstruction techniques Their interaction with rehabilitation is essential for attaining favorable outcomes.[3] Free flap reconstruction is an optimal choice; however, it is expensive, time-intensive, carries a significant risk of anesthesia[4] complications, is technically demanding,[5] and necessitates a well-equipped microsurgical facility. Seroma is characterized as a collection of serous fluid that forms beneath the skin flaps during mastectomy or within the axillary dead space following axillary dissection [6]. The formation of seromas elevates the risk of infection, hinders wound healing, causes flap necrosis, induces chronic pain, leads to wound dehiscence, and consequently extends the recovery period. [7]A widely cited and arguably the most accepted hypothesis posits that surgery disrupts lymphatic channels, leading to the accumulation of fluid known as seroma. This hypothesis is supported by studies that analyzed the drained liquid and compared it to lymph. [8, 9] While seroma is a complication subsequent to breast surgery, it may also lead to additional complications. Primarily, seroma can induce anxiety and discomfort in the patient. Secondly, seroma can cause elevation of the wound flaps, thereby disrupting the healing process. This may lead to wound rupture, flap necrosis, infection, hematoma, delayed healing, extended hospital stay, postponed initiation of subsequent treatment, and deferred rehabilitation [10,11].

In the era of Egyptian civilization, breast cancer in women was the foremost affliction.

documented neoplasm and the most treatable carcinoma of this century. Hippocrates, regarded as the progenitor of contemporary medicine, endorsed surgical intervention as the sole treatment for these patients. The initial radical mastectomy was conducted during the era of Celsus. Redoran (1685-1790) acknowledged the metastatic characteristics of this disease and proposed sequential resection of the primary tumor and axillary lymph nodes.
Surgical intervention has been the predominant treatment for the past 80 years, with nearly all patients undergoing surgery unless explicitly contraindicated. In 1894, Halstead of Baltimore provided a detailed account of radical mastectomy. Recent advancements in medicine have resulted in numerous enhancements and alterations. Conservative chest surgery and Auchincloss's modified radical mastectomy have been essential components of surgical management.

A compound head and neck defect following extensive resection necessitates a multi-layered reconstruction, comprising an intraoral liner, reconstruction of mandibular or maxillary bone, and soft tissue or skin coverage. Free flaps are now regarded as the "gold standard" for reconstructing defects following resection [12]. The pectoralis major myocutaneous flap (PMMC) remains valuable in cases of advanced disease with systemic comorbidities and reduced vessel diameter, which inhibit the use of free flaps. The predominant complication following breast surgery is the accumulation of serous fluid known as seroma.

This study aims to examine the effects of minimizing mechanical dead space through flap-tack to mitigate seroma formation. Research suggests that flap stapling diminishes seroma formation, streamlines postoperative care and dressing, and facilitates early drain removal.

SOURCE OF DATA

All cases of open MRM and Commando neck operated in Dept. of Surgery, MGM Medical college and MY hospital, Indore. The study will include prospective cases for 1 year from date of approval.

Method of collection of Data

• Study design: Randomized controlled study
• Study period : 1 year from date of approval
• Place of study: Department of surgery, MGM Medical College and MY hospital, Indore
• Sample size: minimum 50 cases (25 in each group)

Inclusion criteria

• Age : 18- 65 years
• Patient undergoing skin flap elevation during breast and head and neck surgery. All patients undergoing any one of the following will be included for surgery.

1. Modified Radical Mastectomy / any other Mastectomy for Ca breast.
2. Neck dissection for head & neck surgery
3. Latismus dorsai flap/ pectoral major myocutaneous flap for breast and head and neck reconstruction.
4. Patient of either sex.
5. Patient giving informed consent for participation in study.

Exclusion criteria

1. Patients on anticoagulant therapy
2. Patient who are not willing to participate for the study
3. Patients with prior chemotherapy.
4. Patients with breast irradiation.
5. Patients with Prior breast surgery.
6. Patients with morbid obesity.
7. Patients who do not come to follow up.

METHODOLOGY

• All patients in study will undergo a detailed history taking including general examination and investigations.
• Written informed consent will be taken from all patients included in the study
• Detailed records of clinical history and the examination finding (including
• continuous and category variables) will be maintained as per standard protocol
• Two study groups will be made
• In the study group, written consent will be obtained by the patient who fulfills the inclusion criteria and patient will be enrolled for surgery.
• Enveloped method arranged in Randomized method will be used to random allocate the patient in different groups.
• Patient will be randomized in quilting and non-quilting groups.
• Randomized and concealed allocation will be done using enveloped method.
• Patient allocated to quilting group will undergo quilting of elevated skin flaps.
• The skin flap will be sutured in the underlying muscle using absorbable suture (vicryl). Skin edges will be approximated using standard surgical technique and drain will be kept.
• Patient allocated to non-quilting group will undergo approximation of skin edges and drain will be kept.
• Total operative time of skin closure i.e., of the complication of surgery and before closure will be noted.
• Drain output will be measured in both the groups on day will be noted on day
• 1, day 2 and day 7.
• Drain will be removed as soon as drain output is less than 20 ml.
• Surgical site will be assessed for any site of infection.
• Follow up will be done on day 14 and day 21 to detect any appearance of seroma.

Assessment tools:

• Total drain output after removal of drain.
• Operative time
• Post operative day of drain removal
• Surgical site infection ( as per ICMR guidelines annexure 4)

TABLE 1. Comparision Between Control Group And Interventional Group In Breast Surgery

Table 1 presents a comparison between the interventional and control groups in breast surgery outcomes. On the 3rd postoperative day, both groups showed equal drain volume (50 ml). However, by the 7th day, the interventional group had significantly lower drainage (2 ml) compared to the control group (5 ml). The total drain volume was also reduced in the interventional group (150 ml) versus the control group (200 ml). The duration for drain removal remained the same for both groups (5 days). The incidence of seroma was notably lower in the interventional group (2 cases) compared to the control group (8 cases), and fewer cases of postoperative hematoma were observed in the interventional group (1 case) than in the control group (3 cases). Both groups had an equal number of flap necrosis cases (2 each), suggesting the interventional approach may reduce postoperative complications such as seroma and hematoma without affecting drain removal timing or flap viability.

TABLE 2. Comparing Effect Of Quilting In Age Groups In Breast Surgery

Table 2 illustrates the effect of quilting in different age groups among breast surgery patients. Among those who underwent quilting, 7.7% were under 40 years of age and 92.3% were aged 40 years or older. In contrast, among those without quilting, 25% were under 40 and 75% were 40 or older. Although a higher proportion of older patients underwent quilting, the chi-square test yielded a value of 2.782 with a p-value of 0.095, indicating that the association between age group and quilting was not statistically significant.

TABLE 3. Comparing Effect Of Quilting On Different Site Of Breast

Table 3 compares the effect of quilting based on the site of breast involvement in breast surgery patients. Among those who received quilting, 38.5% had carcinoma of the left breast, and 61.5% had carcinoma of the right breast. Similarly, in the non-quilting group, 37.5% had left breast involvement and 62.5% had right breast involvement. The distribution of cases between left and right breast was nearly identical in both groups. The chi-square value was 0.005 with a p-value of 0.944, indicating no statistically significant association between quilting and the site of breast involvement.

TABLE 4. Comparing Effect Of Quilting On Different Stages Of Breast Cancer

Table 4 examines the effect of quilting across different stages of breast cancer in surgical patients. In the quilting group, 23.1% were in Stage II A, 42.3% in Stage II B, 30.8% in Stage III A, and 3.8% in Stage III B. In comparison, the non-quilting group had 33.3% in Stage II A, 20.8% in Stage II B, and 45.8% in Stage III A, with no cases in Stage III B. While a higher proportion of Stage II B patients underwent quilting and more Stage III A patients were in the non-quilting group, the chi-square value of 3.936 and a p-value of 0.268 indicate that the association between quilting and cancer stage was not statistically significant.

TABLE 5. Comparing Effect Of Quilting On Seroma Collection On Post Operative Days In Breast Surgery

Table 5 compares the effect of quilting on seroma collection across different postoperative days in breast surgery patients. On Day 1, patients in the quilting group had a significantly lower mean seroma volume (36.35 ml) compared to those without quilting (60.91 ml), with a p-value of 0.001 indicating statistical significance. By Day 3, the mean seroma volume remained lower in the quilting group (16.43 ml) than the non-quilting group (27.31 ml), though this difference was not statistically significant (p = 0.162). On Day 7, the seroma volumes were comparable between the quilting (15 ml) and non-quilting groups (14.38 ml), with a p-value of 0.895, indicating no significant difference. Overall, total seroma collection was significantly lower in the quilting group (mean 41.92 ml) than in the non-quilting group, with a p-value of 0.013. These findings suggest that quilting significantly reduces early postoperative seroma formation, particularly on Day 1 and in total volume.

TABLE 6. Comparing Effect Of Quilting On Drain Removals On Post Operative Days In Breast Surgery

Table 6 highlights the impact of quilting on the timing of drain removal in breast surgery patients. The mean day of drain removal for the quilting group was 7.5 days, compared to 9.59 days for the non-quilting group. The standard deviation was 2.929 for the quilting group and 4.032 for the non-quilting group. The difference between the two groups was statistically significant, with a p-value of 0.043. This indicates that quilting facilitates earlier drain removal postoperatively, potentially contributing to faster recovery and reduced hospital stay.

The idea of suturing skin flaps to the underlying muscle and eliminating the axillary space is not novel. Van Bemmel et al. recommended the closure of the dead space, particularly in the axilla. [13]In our study, the incidence of seroma in the quilting group was 8%, compared to 32% in the control group (Table 1). This aligns with the findings of Coveney EC and colleagues in 1993, who reported an incidence of 25% in the suture group compared to 85% in the control group [14]. A comparable figure was documented by Sakkary MA in 2012 in a limited study (20 patients per arm), revealing an overall incidence of 20% in the intervention group compared to 50% in the control group (P = 0.047) [15]. A 2014 study by Ten Wolde and colleagues demonstrated a reduction in seroma incidence from 80.5% in the control group to 22.5% in the quilting group (P < 0.01) [16]. The quilting technique in the present study significantly reduced the total drainage volume. The average age of the quilting group was 50 ± 5 years (range 45–55), whereas the control group had an average age of 46 ± 5 years (range 41–51), with a nonsignificant difference (P value = 0.14). The quantity of drains and the type of drain (suction or passive) did not significantly affect seroma formation [17].

 Research examining the obliteration of dead space following mastectomy. Academic year Trial Type Count Intervention Outcome Chilson et al., 1992 [18] Retrospective Level 3 351 MRM with or without suture flap fixation Suture flap stabilization Significant decrease in seroma Coveney et al., 1993 [19] RCT Level 2: 39 Comparison of suture flap fixation and traditional skin closure 25% incidence of seroma compared to 85% (P < 0.001) Purushotham et al. 2002 [20] RCT Level 2 375 Mastectomy, Breast-Conserving Surgery No drainage with suture flap fixation resulted in 61% compared to 55% (not significant) in modified radical mastectomy, and 47% compared to 51% (not significant) in breast-conserving surgery. Schuijtvlot et al. 2002 [21] Prospective Level 2 study comparing BCS without drainage and suture flap fixation (buttress suture) against conventional surgery. Suture Flap fixation significantly reduces seroma. Sakkary 2012 [22] Potential 40 MRM with or without suture flap fixation Suture flap fixation significantly reduces seroma. Ten Wolde et al., 2014 [23] Reflective analysis 176 MRM with or without suture flap stabilization Suture flap fixation significantly reduces seroma.

The implementation of flap stapling in modified radical mastectomy diminished seroma formation, facilitating the prompt removal of drains and the commencement of the initial chemotherapy cycle prior to discharge, thereby reducing hospital duration. It has also diminished the occurrence of flap formation and postoperative necrosis.
Further research is necessary to ascertain whether flap stitching is responsible for the reduction of seroma formation. Numerous preliminary and prospective studies have demonstrated that suturing the flap to the chest wall during modified radical mastectomy reduces dead space and facilitates a smoother recovery. In head and neck surgeries, it also diminished the occurrence of skin flap formation and postoperative necrosis. The overall drain output was statistically reduced, allowing for early drain removal. Further studies are necessary to elucidate the role of flap suturing in the reduction of seroma formation. However, the overall duration of hospital stay and the incidence of postoperative complications diminished

1. Romrell, L. J., and K. I. Bland. "Anatomy of the Breast, Axilla, Chest Wall and Related Metastatic Sites." The Breast: Comprehensive Management of Benign and Malignant Diseases, edited by K. I. Bland and E. M. Copeland III, 3rd ed., WB Saunders, 2004.
2. Vos, J. D., and B. B. Burkey. "Functional Outcomes after Free Flap Reconstruction of the Upper Aerodigestive Tract." Current Opinion in Otolaryngology & Head and Neck Surgery, vol. 12, 2004, pp. 305–310.
3. Gal, T. J., and N. D. Futran. "Outcomes Research in Head and Neck Reconstruction." Facial Plastic Surgery, vol. 18, 2002, pp. 113–117.
4. Petruzzelli, G. J., et al. "The Influence of Reconstructive Modality on Cost of Care in Head and Neck Oncologic Surgery." Archives of Otolaryngology–Head & Neck Surgery, vol. 128, 2002, pp. 1377–1380.
5. Smeele, L. E., et al. "Morbidity and Cost Differences between Free Flap Reconstruction and Pedicled Flap Reconstruction in Oral and Oropharyngeal Cancer: Matched Control Study." Journal of Otolaryngology, vol. 35, 2006, pp. 102–107.
6. Chong, V. "Cervical Lymphadenopathy: What Radiologists Need to Know." Cancer Imaging, vol. 4, no. 2, 2004, pp. 116–120.
7. Subramanian, S., et al. "The Evolution of Surgery in the Management of Neck Metastases." Acta Otorhinolaryngologica Italica, vol. 27, no. 2, 2007, pp. 309–316.
8. Ferlito, A., and A. Rinaldo. "Osvaldo Suárez: Often-Forgotten Father of Functional Neck Dissection (in the Non-Spanish-Speaking Literature)." Laryngoscope, vol. 114, no. 7, 2004, pp. 1177–1178.
9. Martin, H., et al. "Neck Dissection." Cancer, vol. 4, no. 3, 1951, pp. 441–499.
10. Pugazhendi, S. K., et al. "The Functional Neck Dissection for Lymph Node Neck Metastasis in Oral Carcinoma." Journal of Pharmacy and Bioallied Sciences, vol. 4, suppl. 2, 2012, pp. S245–S247.
11. Robbins, K. T., et al. "Standardizing Neck Dissection Terminology." Archives of Otolaryngology–Head & Neck Surgery, vol. 117, no. 6, 1991, pp. 601–605.
12. Brazilian Head and Neck Cancer Study Group. "End Results of a Prospective Trial on Elective Lateral Neck Dissection vs Type III Modified Radical Neck Dissection in the Management of Supraglottic and Transglottic Carcinomas." Head & Neck, 1999.
13. Pogson, C. J., et al. "Seroma Following Breast Cancer Surgery." European Journal of Surgical Oncology, vol. 29, 2003, pp. 711–717.
14. Stehbens, W. E. "Postmastectomy Serous Drainage and Seroma: Probable Pathogenesis and Prevention." ANZ Journal of Surgery, vol. 73, no. 11, 2003, pp. 877–880.
15. Kuroi, K., et al. "Pathophysiology of Seroma in Breast Cancer." Breast Cancer, vol. 12, no. 4, 2005, pp. 288–293.
16. Montalto, E., et al. "Seroma Fluid Subsequent to Axillary Lymph Node Dissection for Breast Cancer Derives from an Accumulation of Afferent Lymph." Immunology Letters, vol. 131, no. 1, 2010, pp. 67–73.
17. Chand, N., A. Aertssen, and G. Royle. "Axillary 'Exclusion'—A Successful Technique for Reducing Seroma Formation after Mastectomy and Axillary Dissection." ABCR, vol. 2, no. 1, 2013.
18. Agrawal, A., et al. "Concepts of Seroma Formation and Prevention in Breast Cancer Surgery." ANZ Journal of Surgery, vol. 76, no. 12, 2006, pp. 1088–1095.
19. van Bemmel, A. J. M., et al. "Prevention of Seroma Formation after Axillary Dissection in Breast Cancer: A Systematic Review." European Journal of Surgical Oncology, vol. 37, no. 10, 2011, pp. 829–835.
20. Chilson, T. R., et al. "Seroma Prevention after Modified Radical Mastectomy." American Surgeon, vol. 58, no. 12, 1992, pp. 750–754.
21. Coveney, E. C., et al. "Effect of Closing Dead Space on Seroma Formation after Mastectomy—A Prospective Randomized Clinical Trial." European Journal of Surgical Oncology, vol. 19, no. 2, 1993, pp. 143–146.
22. Sakkary, M. A. "The Value of Mastectomy Flap Fixation in Reducing Fluid Drainage and Seroma Formation in Breast Cancer Patients." World Journal of Surgical Oncology, vol. 10, 2012, article 8.
23. Kuroi, K., et al. "Evidence-Based Risk Factors for Seroma Formation in Breast Surgery." Japanese Journal of Clinical Oncology, vol. 36, no. 4, 2006, pp. 197–206.