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Comparison of infection at the site of surgery with or without the use of wound drainage in a patient undergoing emergency abdominal surgery.

A RANDOMISED CONTROLLED TRIAL COMPARING THE SURGICAL SITE INFECTION WITH AND WITHOUT SUB CUTANEOUS CLOSED SUCTION DRAIN FOLLOWING LAPAROTOMY FOR PERFORATION PERITONITIS IN PATIENTS WITH BMI MORE THAN 25.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046734
Enrollment
106
Registered
2022-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K918- Other intraoperative and postprocedural complications and disorders of digestive system Health Condition 2: K918- Other intraoperative and postprocedural complications and disorders of digestive system

Interventions

Intervention1: A subcutaneous closed suction drain will be used at the laparotomy wound closure site.: In the intervention group subcutaneous closed suction drain at the laparotomy wound closure site

Sponsors

Dr Baba Saheb Ambedkar Medical College & Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA 1. All the patients undergoing laparotomy with midline incision. 2. Patients aged between 11 – 70 years 3. Patients with co-morbidity Diabetes Mellitus, HTN, Hypothyroidism, and cardiac and pulmonary diseases will also be included. 4. Patients with a BMI of more than 25 EXCLUSION CRITERIA 1. Patients age 70 years 2. Re-do laparotomy surgeries 3. Patients who are immune compromised like long-term steroid usage, HIV, or autoimmune diseases. 4. Patients with severe anemia Hb 5. Patients on steroid intake. 6. Patients with a history of radiotherapy over the abdomen. 7.. Patients with hepatic insufficiency like CLD. 8. Patients with renal insufficiency like CKD.

Exclusion criteria

Exclusion criteria: •Patients age 70 years •Re-do laparotomy surgeries • Patients who are immune compromised like on long-term steroid usage, HIV, or any autoimmune diseases •Patients with severe anemia Hb •Patients on steroid intake, radiotherapy over the abdomen •Patients with hepatic and renal insufficiency like CLD, CKD

Design outcomes

Secondary

MeasureTime frame
Effect of closed suction drain in reducing the incidence of seroma, hematoma, secondary suturing ,wound dehiscence, duration of hospital stay when compared to simple closure.Timepoint: From immediate post-operative period to thirty days after the surgery.

Primary

MeasureTime frame
Signs and symptoms of surgical site infections like tenderness, swelling, erythema, discharge, wound dehiscence, local temperature at wound site, and raised body temperature. Interventions done for surgical site infection will also be observed like removing sutures and keeping the wound open for healing by secondary intention, or doing a secondary suturing afterwards. Complications due to surgical site infection like delayed wound healing and non healing of wound will be looked for. Basic blood investigation like complete blood count, blood sugar, serum albumin, total leucocyte count, will be done and if needed imaging will be done by x-ray, ultrasonography, computed tomography, or Magnetic Resonance Imaging to confirm the surgical site infection and it’s complications. Culture and sensitivity of the discharge from the wound will also be looked for.Timepoint: Following operation of the patient, both group i.e. with drain and without drain will be observed on day 3, day 7, after one month for signs and symptoms of surgical site infection.

Countries

India

Contacts

Public ContactDr DARA VINAY KUMAR

DR BABA SAHEB AMBEDKAR HOSPITAL

jkumar33@ymail.com9968242627

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026