The Usefulness of two techniques (Negative Pressure wound therapy vs Standard surgical dressing) of dirty laparotomy wound with respect to the incidence of infection at the surgical site.
- Conditions
- Peptic ulcer, site unspecified, unspecified as acute or chronic, without hemorrhage or perforation, (2) ICD-10 Condition: K461||Unspecified abdominal hernia withgangrene, (3) ICD-10 Condition: K37||Unspecified appendicitis, (4) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (5) ICD-10 Condition: K928||Other specified diseases of the digestive system,
- Registration Number
- CTRI/2023/12/060540
- Lead Sponsor
- S NANDHA KUMAR
- Brief Summary
Surgical siteinfections are common hospital-acquired infections (HAIs) and are associatedwith high morbidity and mortality. Among the HAIs, Surgical Site Infection(SSI) is serious complication causing increasing morbidity and currently one ofthe most important among the HAIs comprising 20% of it.1,10 SSIsare responsible for an additional 7-11 days of hospital stay.19 Theincidence of SSI vary widely from 3 to 34% and is responsible for considerableincrease in the cost of treatment.4,6 Evenwhen using best practices, many factors associated with SSIs are not easilymodifiable, including use of neoadjuvant therapy and the length of operation.However, one actionable area is the management of surgical incision. This canbe achieved by application of wound protectors, disinfectants to the skin, orspecialized dressings.11,20 Amajority of studies evaluating the impact of using such interventions iscomposed of retrospective studies, which often suffer from selection bias.
Negative-pressurewound therapy (NPWT) devices were designed to remove fluids from the incisionalwound in the early postoperative phase, to reduce tensile forces across theincision and to protect the incision from external contamination. Negativepressure wound therapy (NPWT) on closed, clean incisions, has emerged as aprophylactic option to reduce the risk of SSI in high- risk incisions.15,16
Standard et al.,have done a study of pNPWT in extremity fractures (open reduction and internalfixation). There was a total of 23 infections in control group and 14 in NPWTgroup, which represented a significant difference in favor of NPWT (p = 0.049).The relative risk of developing an infection was 1.9 times higher in controlpatients than in patients treated with NPWT (95% confidence interval,1.03–3.55).13
In a study done byShen et al., he found no significant differences in superficial SSIs (12.8% vs.12.9%; p > 0.99) or deep SSI (3.0% vs. 3.0%; p > 0.99) rates between theSSD and NPWT groups, respectively. In the univariate and multivariate logisticregression analysis of demographic and operative factors for the development ofcombined incisional SSI, the only independent predictors were preoperativealbumin (p = 0.0031) and type of operation (p = 0.018).21
Another prospective study evaluated healing ofpostoperative sternotomy wounds after their primary closure with NPWT, usingcontinuous negative pressure of -80 mmHg in 40 patients and 40 patients in acontrol group in whom conventional dressings were applied in the postoperativeperiod. They found that the number of patients in whom primary wound healingoccurred without complications was significantly higher in the NPWT groupversus the control group (x2 test =4.50, p=0.0339) and the number of totalsuperficial infections was significantly smaller versus the control group (x2test =5; p=0.0254). Antibiotic therapy was also initiated significantly lessoften as compared to the group treated with conventional dressings (X2test = 4.11; p=0.0425).15
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 132
Patients over 18 years of age with dirty laparotomy wound including abdominal trauma undergoing emergency laparotomy.
1.Patients undergone previous laparotomy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Negative Pressure Wound Therapy will Maximum of 10 days after the operation or till discharge of patient whichever is earlier. reduce the incidence of surgical site infection and the associated morbidities in patients undergoing midline laparotomy. Maximum of 10 days after the operation or till discharge of patient whichever is earlier.
- Secondary Outcome Measures
Name Time Method Participants will be assessed for scar cosmesis at 4 weeks & 12 weeks after surgery Participants will be assessed for scar cosmesis at 4 weeks & 12 weeks after surgery
Trial Locations
- Locations (1)
Jawaharlal Institute Post Graduate Medical Education and Research, Puducherry
🇮🇳Pondicherry, PONDICHERRY, India
Jawaharlal Institute Post Graduate Medical Education and Research, Puducherry🇮🇳Pondicherry, PONDICHERRY, IndiaS NANDHA KUMARPrincipal investigator6374763821nandhunks57@gmail.com