European Journal of Cardiovascular Medicine

Surgical site infections (SSIs) refer to wound infections subsequent to an invasive surgical procedure (Source 1). Despite advancements in surgical techniques and medical care, SSIs remain a significant concern for patients undergoing procedures. Class IV surgical wounds, characterized by old traumatic wounds with retained devitalized tissue, procedures with existing clinical infection, or perforated viscera, exhibit an incidence rate of Incisional Surgical Site Infection (Incisional SSI) exceeding 30% (Sources 2, 3, 4). Incisional surgical site infections contribute to delayed wound healing, heightened patient discomfort, unfavorable cosmetic outcomes, prolonged hospital stays, increased treatment costs, and a heightened risk of developing incisional hernias (Sources 3, 4, 5). Utilizing subcutaneous drains aids in removing collections and eliminating dead space, potentially reducing the rate of wound complications (Sources 6, 7). However, their use may also elevate morbidity, exacerbate patient suffering, and diminish quality of life (Sources 8, 9, 10).

Numerous interventions have been proposed to mitigate SSIs, many of which are standard practice, including hand washing, minimizing shaving, skin preparation, and preoperative antibiotics (Sources 11, 12, 13, 14). Conversely, the utilization of drains post-surgery has diminished over time, with uncertain universal acceptance (Source 15). Furthermore, drains may not consistently demonstrate efficacy and can lead to discomfort and prolonged hospitalization (Source 15). Patients experiencing wound morbidity often exhibit extended wound drainage periods compared to those without complications. Nonetheless, it remains uncertain whether prolonged drain placement increases the risk of wound complications or if extended drainage periods result from such complications.

Subcutaneous drains may mitigate bacterial presence around wounds and remove residual effusion and blood, potential mediums for bacterial growth. Closed drains, utilizing suction, experience luminal obstruction over time, leading to decreased drainage efficacy approximately 48 hours post-insertion (Source 16).

The literature on the role of subcutaneous drains in preventing local wound complications is limited globally. Laparotomy, among the most common operations in general surgical units, presents increased morbidity in patients with wound collections. Corrugated drains, cost-effective, user-friendly, and readily available, are recommended for all cases of class IV (dirty contaminated) surgical wounds post-sheath closure. Their use demonstrates significant reductions in wound complications, improved patient compliance, reduced hospital stays, without increasing nosocomial infection rates. This study aims to assess the role of subcutaneous drains in reducing SSIs in class IV laparotomy wounds.

This quasi-experimental study was conducted at the Department of General Surgery, Institute of Gastroenterology Sciences & Organ Transplant, Bengaluru & Rajarajeshwari Medical college & Hospital, Bengaluru. The study enrolled patients aged 15 years and above, who presented at the outpatient department (OPD) or emergency department for emergency laparotomy surgery and were admitted to the hospital during the study period spanning one year from December 1, 2022, to November 31, 2023.

The study comprised an interventional group of 55 patients and a control group of 55 patients. Randomization was performed by allocating pairs of study subjects with common etiology and type of surgery to either the subcutaneous drain group or the control group using computer-generated random numbers.

Inclusion criteria encompassed patients undergoing class 4 laparotomy procedures, regardless of associated conditions such as diabetes, malignancy, or other immunocompromised conditions. Both male and female patients were included.

Exclusion criteria consisted of patients aged less than 15 years.

Data collection involved obtaining written consent from all potentially eligible subjects and excluding those who did not meet the inclusion criteria. Detailed history and physical examinations were conducted and recorded on a pre-designed proforma for each patient. A prospective audit was conducted on all patients in the post-operative period across three general surgical wards during the study. Patients were followed up, and after confirmation of the diagnosis, laparotomy was performed, and subcutaneous drains were placed. Wounds were monitored three to seven days after surgery for the development of Surgical Site Infections (SSIs). Other nosocomial infections were not recorded.

Patients were assessed for systemic (fever, chills) and local (pain, redness, warmth, swelling, purulent drainage) signs of infections. Redness of the incisions was not considered a parameter for SSI. The investigator performed bedside observations on the third, fifth, and seventh days of the post-operative period. Surgical incisions were examined during dressing changes, and patient records were reviewed. Patients readmitted to the hospital were also observed for infections. If one patient underwent two or more operations more than thirty days apart, each operation was considered independent. If the second operation was a result of SSI, it was recorded as a consequence of the SSI. In cases of SSI, the type of SSI, according to CDC criteria, date of onset, and cultured microorganisms were reported. Treatment administered, readmissions, and reoperations were documented. Infections confined to the skin and subcutaneous tissue were classified as superficial, with the presence of swelling, tenderness, and obvious pus oozing serving as the main determinants for inclusion in this category. Abscesses were opened in the ward for drainage under aseptic conditions, while pus swabs were taken for microbial sampling. Patients with such wounds were not re-operated, but secondary repair was undertaken after control of sepsis.

Deep/organ SSIs were identified either through ultrasonography, clinical signs of intra-abdominal sepsis, or during surgery. Specimens were obtained using sterile swabs with aseptic technique, followed by immediate transport and processing. Continuous monitoring of culture systems was conducted to detect growth, identify organisms, and perform antibiotic sensitivity testing within 16 hours. Reading of the Antibiotic Sensitivity Test was performed 16 hours after placing the antibiotic disc.

Statistical analysis was carried out using Statistical Package for Social Sciences, version 23 (SPSS Inc., Chicago, IL). Continuous variables were presented as mean ± standard deviation, while categorical variables were presented as number (percentage). Chi-square/Fisher exact test was employed to determine the significance of study parameters on a categorical scale between two or more groups. Results were presented in the form of tables, graphs, and diagrams, with a significance level set at P < 0.05.

Demographic details revealed that the mean age of subjects in the experimental group was 35.38 years with a standard deviation (SD) of 9.05, while in the control group, the mean age and SD were 98.21 and 14.78, respectively. The mean age difference between the groups did not exhibit statistical significance. Male subjects predominated in both groups, comprising 41 (74.5%) and 42 (76.4%) in the drain and non-drain groups, respectively, followed by females. Gender distribution did not demonstrate significance between the groups.

Table No-1:  Distribution of patients on the basis of presenting complaints

From Table 1, it was evident that abdominal pain was present in all studied patients in both groups, followed by vomiting, reported by 21 (38.2%) in the drain group and 23 (41.8%) in the non-drain group, with constipation being the next most common complaint. The least reported symptom was nausea, with 3 (5.5%) and 10 (18.2%) occurrences in the drain and non-drain groups, respectively. Significant association was observed with nausea, while the other symptoms showed no significance. Abdominal examination revealed that most patients exhibited tenderness, with 20 (36.4%) and 24 (43.6%) cases in the drain and non-drain groups, respectively, the latter showing a comparatively higher incidence. Tenderness with guarding was the next most common finding, while tenderness with rigidity was the least reported, and these findings were statistically insignificant.

Table No-2:  Pre-operative Haematological findings

From Table-2, mean values of pre-operative findings in both groups showed statistical significance for TC and SGPT, while other parameters were not significant.

In patient diagnoses based on Chest X-ray and Abdomen X-ray, free gas was predominant in the drain group (50.9%), followed by NAD (29.1%), and least common was Multiple Air Fluid levels (20%). Conversely, in the non-drain group, Multiple Air Fluid levels were predominant (50.9%), followed by NAD (25.5%), while Free Gas was least common (23.6%). This distribution was statistically significant.

Table No-3: Distribution of patients based on intra-operative findings

From Table-3: Intraoperative observations of the patients revealed that a significant portion of them exhibited Peptic Perforation, with 30 (54.5%) in the drain group and 26 (47.3%) in the group without drain, followed by Perforated Appendix, with 16 (29.2%) and 14 (25.5%) in their respective groups.

Table No-4: Distribution of patients on the basis of abdominal drain parameters and abdominal closure technique

From Table-4: The distribution of patients based on suture parameters between the groups showed statistical significance. Removal of stitches on post-operative day was notably lower in the drain group, while the association was insignificant regarding duration of surgery. Intraperitoneal Drain closure was observed in all cases across both groups.

Post-operative findings revealed that in the drain group, fever (47.3%) and local site pain (47.3%) were the most prevalent complications, followed by tenderness (40%) and redness (38.2%), while discharge was the least common (20%). Conversely, in the group without drain, fever (49.1%) was predominant, followed by tenderness (47.3%) and discharge (45.5%), with redness being the least common (25.5%). The difference in discharge between the groups was statistically significant.

Table No-5: Distribution of patients based on subcutaneous corrugated drain removal (outcome)

From Table-5, recovery based on drain removal procedures (outcome) indicated statistically significant associations with the removal of corrugated drain (days), wound dehiscence, total days of dressing, and secondary suturing. These findings suggest that the drain group performed better. However, the duration of hospital stay showed no significant difference between the groups.

Table No-6: Distribution of patients based on infection

From Table-6, the distribution of patients affected by culture organisms revealed that the majority were affected by E. coli, with 6 (10.9%) cases in both the drain and non-drain groups, followed by Klebsiella, with 2 (3.6%) and 4 (7.3%) cases, respectively. Additionally, 47 (85.5%) cases in the drain group were unaffected by the organisms, which was comparatively lower than the non-drain group, where 41 (74.5%) cases were unaffected.

Regarding surgical site infection, it was found to be statistically higher in the non-drain group, with 32 (58.2%) cases, compared to the drain group, with 9 (16.4%) cases.

Age: In our study, the mean age of patients with drains was 35.38±9.05, and without drains was 38.21±14.78, aligning with previous studies by Kumar S¹⁷ ,Patel BJ¹⁸, and Bindal J et al^19, suggesting that individuals in their thirties and forties are most affected.

Gender Distribution: We observed male predominance in both groups, consistent with studies by Kumar S¹⁷, Gupta P²⁰, and Patel BJ¹⁸, indicating that males are more affected by subcutaneous drain with class 4 laparotomy wounds than females.

Pre-operative Hematological Findings: Only TC and SGPT were statistically significant between drain and non-drain groups, while other parameters showed no association. Previous studies have not extensively discussed hematological parameters.

Clinical Findings: Abdominal pain was prevalent in all patients, with vomiting and constipation also common. Nausea was significantly associated, while other symptoms and abdominal tenderness showed no significance, which differs from previous studies.

Intra-operative Findings: Peptic Perforation and Perforated Appendix were the most common intraoperative findings, consistent with findings by Patel BJ¹⁸ and Kumar S¹⁷.

Post-operative Complications: Fever and local site pain were predominant post-operative complications, with discharge more common in the non-drain group. Similar complications were reported by Patel BJ et al¹⁸.

Hospital Stay: Hospital stay was longer in the non-drain group, consistent with findings by Kumar S¹⁷ and Patel BJ¹⁸, indicating increased morbidity and hospital stay without drains.

 Distribution of Patients Based on Infection: E. coli and Klebsiella were the most common organisms, with a higher incidence of surgical site infection in the non-drain group, supported by Patel BJ¹⁸. These findings align with studies reporting reduced surgical site infections with drains.

 Studies Reporting on Drain Efficacy: Some studies suggest subcutaneous drains do not reduce Incisional SSI, but numerous others demonstrate efficacy, especially negative suction drains, in improving wound healing by reducing bacterial load and promoting granulation tissue formation.

 Limitations: Our study had a small sample size, necessitating larger randomized clinical trials for confirmation.

Strengths: Our study adhered to a consistent proforma, ensuring methodological rigor & it was multicentric study.

In conclusion, our study suggests that the use of subcutaneous drains in class IV laparotomy wounds does not significantly affect postoperative pain or redness but is associated with reduced wound discharge. Hospital stays were longer in the group without drains, and instances of wound dehiscence and secondary suturing were more prevalent in this group. E. coli was the most commonly occurring culture organism in both groups, followed by Klebsiella.

Notably, surgical site infections were observed in 58.2% of cases in the group without drains, compared to only 16.4% in the drain group. This highlights the significant role of subcutaneous drains in reducing surgical site infections in class IV laparotomy wounds, regardless of associated comorbidities. However, these findings should be further validated through larger-scale clinical trials.

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