European Journal of Cardiovascular Medicine

Surgery is derived from the earlier name chirurgery (old French word), which means handwork. It is a science and art that shows the manner in which to work on man’s body exercising all manual operations necessary to heal or as much as possible using most expedient medicines or techniques. The goal of surgery is to achieve healing by such means with minimal edema, no serous discharge or infection, without separation of the wound edges and with minimal scar formation. After any surgical procedure (assuming there are no tension and a good blood supply) careful approximation of the tissues will allow healing by primary intention. Precise approximation of skin incisions and lacerations with wound closure devices is critical for a favorable cosmetic and functional surgical result. Principles of wound closure focus on relieving tension on the wound and bringing the skin edges together in an everted orientation. If sutures are tied too tight or left in too long, they may leave permanent suture tracts if sutures are removed before adequate healing, the lack of wound tensile strength may result in wound dehiscence or a widened scar. Wound closure includes ensuring a clean wound with satisfactory vascularity and hemostasis and apposition without wound tension. Principles of wound closure focus on relieving tension on the wound and bringing the skin edges together in an everted orientation. “Surgery is the first and the highest division of the healing art, pure in itself , perpetual in its applicability , a working product of heaven and sure of fame on earth “ SUSHRUTA (400 B.C.) Surgical site infection (SSI) is the most common nosocomial infections reported in the hospital patients. Up to 2.5% of the patients undergoing clean extra abdominal operations and upto 20% of intra-abdominal operations will develop SSI. SSI remains a complication of surgical procedures resulting in increased morbidity, mortality and cost. Infection remains the most significant factor affecting wound healing. A closure that penetrates the epidermis and dermis only serves to auto – inoculate the wound of the patient, driving surface    flora deep into the subcutaneous tissue. Percutaneous suture closure provides an extra source of contamination through the suture canal and results in a thinperisutural cuff of dead epidermis, dermis, and subcut aneous fat. Suture                                                                                                                                          closure also is a potential source of foreign body reaction within the susceptible subcutaneous tissue [1]. The type of suture material for skin closure is also reported to influence post-operative wound complications. However, several other studies have failed to demonstrate significant differences between different types of suture material. The surgical scar remains the only visible evidence of the surgeon’s skill and not infrequently, all of his efforts are judged on its final appearance. Skin staples give a neat scar with good wound eversion and minimal cross-hatching effect. They can be placed faster than sutures and have a lower predisposition to infection because they do not penetrate entirely through the wound and do not produce a complete track from one wound to the other [2]. When the surgeon suture a clean incision, healing takes place with minimum loss of tissue and without significant bacterial infection with minimal scarring. With passage of time and availability of newer methods of skin closure, it has become an art with stress on better cosmetic results. Any method of skin closure should provide adequate approximation of the tissue to allow wound healing with minimal risk of infection and should produce an acceptable cosmetic result. The method should be simple, quick to use and cost effective. Since long the art of suturing is emerging continuously for the betterment of the patient in terms of cosmetic appearance, minimal scar, decreasing the risk of infection, better patient compliance, thus overall decreasing the morbidity. So, with the application of skin staple in skin closure of modified radical mastectomy it has been found that the wound closure time was much faster which was statistically significant and also it has a great impact on post operative recovery as the patient can be weaned off from the anaesthesia faster and thereby reducing overall operating time and hence decreasing post operative morbidity and mortality. Post operative pain was significantly lesser and wound healing was better with minimal infection. As a result, the patient can be discharge early and the hospital duration of the patient was lesser with the use of skin stapler in modified radical mastectomy. Surgical wound closure aims to move close the skin flaps to favor rapid healing and a good cosmetic outcome with low risk of complications. Infection of surgical wound is a relevant complication with an incidence of 1% to 3%; it is favoured by age, underlying illness (American Society of Anesthesiologists score of three or more, diabetes, malnutrition, low serum albumin, radiotherapy, and steroid use), obesity, host immune status, smoking, site, level of wound contamination. [3, 4] Further significant risk factors are related to type and complexity of the surgical procedure, duration of operation, type of surgical approach (laparotomic or laparoscopic or robotic). [5] Wound dehiscence is another complication of surgical procedures that may increase the inpatient stay, resulting in additional costs, and it has a 9.6% attributable mortality. Further surgical wound complications are the formation of hypertrophic or keloid scarring. The cosmetic appearance of the scar after healing is a relevant outcome, which affects the satisfaction of patients. A meticulous surgical technique is needed to avoid local swelling, dehiscence of the wound, and a poor cosmetic result. Different methods and materials are used for wound closure and they are highly dependent on the type of surgery, the length and anatomical site of the wound. [6] Skin closure of surgical wounds is usually achieved with sutures. Sutures can be continuous or interrupted and the material used can be natural or synthetic, absorbable or non-absorbable, single filament or braided, depending on the length and anatomic location of the wound. The principal advantages of sutures are their flexibility, strength, non-toxicity, and in vivo degradation properties. Staples are a valid alternative to sutures and are mainly made of stainless steel, although staples using absorbable materials are now available. [6] Although the sutures are the most common technique of closure, they could increase the risk of wound infection. In fact, the sutures could cause the ischemia of the wound flaps and this hinders a regular healing. The potential advantage of staples in surgical wound closure is related to their low level of tissue reactivity. [7] This generates a higher resistance to infection in contaminated wounds, given the non-introduction of exogenous material, and consequent impairment of local immune response. [8] Furthermore, it is thought that the use of staples reduces the local inflammatory response, width of the wound, time to wound closure, and residual cross marks.[9,10] Even if the skin closure is conventionally performed by sutures, staples seem to be better in terms of efficacy of fixation, good cosmetic results and rapidity of application. However, in literature, it is unclear which is the best skin closure technique between sutures and staples. While some RCTs report that there is no difference between two methods in terms of overall wounds infections, [11, 12] others report higher rates of wound complications following the use of staples. [13].

This study was conducted in the female patients attending the Breast clinic , Department of General surgery in Agartala Government Medical College and G.B Pant Hospital , which is a tertiary referral hospital of Tripura State. The department and hospital has good patient inflow and is adequately equipped for the conduction of this study.

Study design: Prospective study.

Type Of Study: Hospital based prospective study.                                                                                                            

Study setting:  This study was conducted in the Dept. of General Surgery, AGMC & GBP Hospital.

Duration Of The Study: 1 and ½ years (October 2018 – May 2020)

Sample Size: As per previous records available, the no. of patients who underwent Modified Radical Mastectomy are:

2015 = 24 patients

2016 = 28 patients

2017 = 30 patients

Mean = 24 +28+ 30 = 82/3 = 27.3 per year

No. of patients in one and half year = 40 patients

Sampling Design: Census sampling and patients were selected consecutively.

Inclusion Criteria: All female patients with diagnosed Ca Breast, in whom modified radical mastectomy was perform.

Exclusion Criteria:

• Psychiatric patients
• Immuno compromised states like TB , HIV
• Patients having uncontrolled diabetes
• Patients who refused to cooperate for the entire study period.

Materials:

The materials used for study include:

• Sterile disposable skin stapler in which each Stapler contains 35 stainless steel staples 6.9mm * 3.6 mm
• Non absorbable suture material like 1-0 or 2-0 ethilon material
• Betadine 10 % solution
• Dressing with sterile gauze and adhesive tape.

The parameters which shall be compared:

• Operative time taken for closure
• Post operative wound healing
• Post operative pain
• Duration of hospital stay.

Methods: Patients with diagnosed Ca breast and plan for Modified Radical Mastectomy were subjected for this study. Informed consent was obtained after informing the study subjects the details of the procedure. With tossing a coin, the patients were divided into two groups for skin staple and skin suture. If head appears, patients were go to suture group and if tail appears the patient were go for staple group. A detailed history of each patient was obtained, starting with a history of presenting symptoms and any coexisting, comorbid conditions such as DM, TB and HIV.

Preoperatively all patients were undergo following investigations:

• Complete blood count , urine examination
• Bleeding time , Clotting time
• Blood sugar , blood urea , serum creatinine
• Liver function test
• Chest X ray , ECG
• Viral markers

The cases were only elective surgeries and the mode of anesthesia was general anesthesia. All patients were received one mandatory dose of pre-operative parenteral antibiotic before surgery. Painting was done with 10 % povidone iodine solution for all cases. For all patients sub cutaneous sutures were put to relieve tension, dead space was closed and wound edges apposed. Then the wound was closed by skin staples or skin sutures. Wound was evaluated for one week, then at one month.   Wound was evaluated for erythema, infection , swelling , serous discharge, overlap of edges, separation of edges , wound dehiscence, hypertrophic scar. Wound appearance was determined by 4 item ordinal scale. Wound was assigned 0 or 1 point.                                                                                                                          

for each for the presence or absence of the following:

• Step of borders (0 for yes , 1 for no)
• Contour irregularities-puckering (0 for yes, 1 for no)
• Wound margin separation (0 for yes , 1 for no)
• Good overall appearance (0 for poor , 1 for acceptable)
• Wound with a score of 4 is considered to have an optimal cosmetic appearance , others sub optimal appearance
• Visual analogue scale was used for examining post operative pain.

Statistical Analysis: Data were entered into Microsoft Excel and analysed using SPSS (version 27.0) and Graph Pad Prism (version 5). Numerical variables were summarized as mean ± standard deviation, while categorical variables were presented as counts and percentages. Statistical analyses included independent (unpaired) and paired t-tests for comparing means, and Chi-square or Fisher’s exact tests for comparing proportions. A p-value ≤ 0.05 was considered statistically significant.

Table 1: Comparison of Demographic Characteristics between Stapler and Suture Groups.

Table 2: Clinical Profile and Postoperative Outcomes Comparison between Stapler and Suture Groups.

Figure: Comparison of Stapler vs. Suture Groups in Terms of Patient Characteristics, Postoperative Pain, and Wound Healing

In our study, the distribution of patients based on demographic and socio-economic characteristics was analyzed between the stapler and suture groups. The majority of patients were in the 40–50 age group, comprising 55% of the stapler group and 40% of the suture group, but this difference was not statistically significant (p = 0.4648). The mean age in the stapler group was 51.6 ± 5.98 years, while in the suture group it was 53.15 ± 6.51 years, also showing no significant difference (p = 0.4376). With respect to religion, 60% of patients in the stapler group were Hindu compared to 85% in the suture group, whereas Muslims accounted for 40% and 15% of the stapler and suture groups, respectively. This difference approached but did not reach statistical significance (p = 0.0766). In terms of occupation, housewives constituted the majority in both groups (70% in stapler vs. 75% in suture), while employees made up 30% and 25% of the stapler and suture groups, respectively. This association was not statistically significant (p = 0.7232). Regarding socio-economic status, 30% of stapler patients and 40% of suture patients were from the Above Poverty Line (APL) category, while the remaining 70% and 60%, respectively, were from the Below Poverty Line (BPL) category. This difference was not statistically significant (p = 0.5073).

In our study, all patients in both stapler and suture groups were non-vegetarian (100%), and all had undergone preoperative imaging including USG/Mammography and FNAC/True cut biopsy. Furthermore, all patients underwent Modified Radical Mastectomy (MRM) as the surgical procedure. As these variables were consistent across both groups, statistical analysis was not applicable (NA). Postoperative pain was assessed, and while the majority of patients in both groups experienced moderate pain, it was more prevalent in the stapler group (95%) compared to the suture group (80%). Severe pain was reported in only 5% of the stapler group but in 20% of the suture group; however, this difference was not statistically significant (p = 0.1514). Wound healing outcomes showed a significant difference between the two groups. In the stapler group, 90% of patients had a healing score of 4 (best outcome), while only 20% in the suture group achieved the same score. Conversely, a score of 3 was observed in 65% of the suture group.

In the present study, we observed that the distribution of patients based on demographic and socio-economic characteristics between stapler and suture groups did not show any statistically significant differences. Similar findings have been reported in previous studies, where demographic factors such as age, occupation, and socio-economic status were found not to influence wound healing outcomes post-surgery significantly [14,15]. Our mean age of patients across groups aligns with studies by Sharma et al. [16] and Patel et al. [17], who reported comparable mean ages in cohorts undergoing Modified Radical Mastectomy (MRM). Additionally, the predominance of housewives in our cohort reflects the social and cultural context of breast cancer epidemiology in India, as noted by Gupta et al. [18]. Dietary habits, imaging protocols, and preoperative biopsy methods were uniform across groups, consistent with standard breast cancer management guidelines. These factors are procedural necessities and thus expectedly showed no intergroup variation, aligning with observations from similar Indian and international surgical cohorts [19,20]. Postoperative pain analysis in our study revealed no significant difference between stapler and suture groups, although a trend toward less severe pain in the stapler group was noted. This finding is consistent with studies by Kulkarni et al. [21] and Singh et al. [22], which reported no substantial difference in postoperative pain but highlighted patient comfort and faster mobility in stapler groups due to minimal skin tension.

The most remarkable finding in our study was the significant difference in wound healing outcomes. Patients in the stapler group had superior healing scores compared to those in the suture group, with 90% achieving the best possible score. Similar results were reported by Sharma et al. [23], where stapler closure was associated with reduced wound complications, faster healing, and better cosmetic outcomes.

In our study, the use of skin staplers for wound closure following Modified Radical Mastectomy (MRM) demonstrated superior outcomes in terms of wound healing when compared to traditional sutures. Although there were no significant differences between the groups concerning demographic variables, socio-economic status, dietary habits, preoperative investigations, or the type of surgical procedure performed, wound healing was notably better in the stapler group. Patients in the stapler group experienced higher rates of optimal wound healing scores, with significantly fewer cases of delayed healing compared to the suture group. While postoperative pain was slightly less severe in the stapler group, this difference did not reach statistical significance. Overall, our findings suggest that stapler closure is associated with improved postoperative wound outcomes and may be preferred over sutures in breast surgeries like MRM when feasible. This study supports existing literature advocating for the wider adoption of staplers in surgical practice to enhance patient recovery and reduce wound-related complications.

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