Surgical Wound Infection
Conditions
Keywords
Surgical Wound Infection, Seroma, Hematoma, Lymphorrhagia, Lymphocele, Extended Hospital Admission, Postoperative Mortality
Brief summary
Comparison between waterproof sterile dressing OPSITE Post-Op Visible, Smith & Nephew, UK and PICO-7, Smith & Nephew, UK in terms of inguinal surgical wound infection and complications after lower limb revascularization.
Detailed description
Patients will follow a preoperative preparation: * Routine pre-surgical skin hygiene with soap or antiseptic agent * Groin shaving with a machine * Preoperative antibiotic prophylaxis with cefazolin 2 gr ev. single dose or clindamycin 900 mg ev. in case of allergy to beta-lactams 30 min before the start of the intervention. In case of prolongation of the intervention (\> 4h), a second antibiotic dose will be administered * Surgical field antisepsis using a sterile swab soaked in 2% chlorhexidine solution in 70% isopropyl alcohol, except for contraindications (such as potential contact with mucosa or open wounds, in which case 10% povidone-iodine solution will be used); usual sizing. At the end of the revascularization surgical procedure, the inguinal wound will be closed using 2-0 or 3-0 Vicryl subcutaneous absorbable suture (Ethicon Inc, Somerville, NJ, USA) in two independent planes and skin closure with metal staples (B / Braun Manipler® AZ). The opaque randomization result allocation envelope will then be opened and the surgical area nurse will cover the wound with one of the two assigned dressings: * Group 1 (intervention group): The surgical wound will be covered in a sterile manner with prophylactic TPN (PICO-7, Smith & Nephew, UK). * Group 2 (control group): The surgical wound will be covered in a sterile way with the usual dressing (waterproof sterile dressing OPSITE Post-Op Visible, Smith & Nephew, UK). During admission, regular follow-up will be carried out. On the 7th day, the dressings of both groups will be lifted. From this moment, if the wound allows it, air healing will be carried out without new dressings. After discharge from the hospital, the surgical wound evaluation will be carried out by the nurse responsible for Outpatient Consultations at 14 and 30 days postoperatively.
Interventions
OTHERRegular waterproof sterile dressing.
Waterproof sterile dressing OPSITE Post-Op Visible, Smith & Nephew, UK
OTHERProphylactic Negative Pressure Dressing
Negative wound pressure dressing: PICO-7, Smith & Nephew, UK
Sponsors
Kerbi Alejandro Guevara-Noriega, Sabadell, Parc Tauli, Spain
Elena Gonzalez Canas, Sabadell, Parc Tauli, Spain
Marta Camats Terre, Sabadell, Parc Tauli, Spain
Eduardo Arrea Salto, Sabadell, Parc Tauli, Spain
Antonio Giménez Gaibar, Sabadell, Parc Tauli, Spain
Marta Santos Espi, Sabadell, Parc Tauli, Spain
Corporacion Parc Tauli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Once it is confirmed that the patient meets the inclusion criteria, exclusion criteria have been ruled out and after signing the corresponding informed consent, randomization will be carried out. The randomization will be carried out by the research center, and the assignment will be made through opaque envelopes. The assignment of the intervention group will be made by the nursing staff of the surgical area. In cases where a bilateral inguinal approach coexists in the same surgical procedure, the right side will be randomized; the contralateral incision will receive alternative therapy by default.
Intervention model description
2 parallel groups receiving different interventions
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-90 * Undergoing elective revascularization surgery (Rutherford clinical categories 4-6 / Fontaine III and IV) requiring a longitudinal inguinal approach (a longitudinal inguinal incision is defined as the one that runs from the inguinal ligament to the femoral bifurcation, performed with the intention of approaching the vascular bundle). * Surgery performed by investigator and co-investigators: Vascular Surgeons of the Vascular Surgery Department at the Parc Taulí Hospital. * Patients must be able to understand the study and sign the specific informed consent before surgery.
Exclusion criteria
* Urgent surgery * Interventions in which transverse groin wounds. * Presence of active groin infection that prevents primary closure * Pediatric patients, pregnant women or patients with impaired higher functions who cannot understand the study or collaborate with its protocolized follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Wound Infection Rate | 30 days | Number of participant with surgical wound with inflammatory signs according to the treating surgeon criteria in the first 30 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroma or lymphocele rate | 30 days | Number of participant with subcutaneous non-hematic liquid collection in the surgical bed of a closed wound. Its suspicion according to medical criteria will require puncture drainage and microbiological culture in 30 days after surgery |
| Surgical wound dehiscence rate | 30 days | Number of participant with separation of the edges of part or all of a previously sutured wound in the 30 days after surgery |
| Rate of Hematoma | 30 days | Number of participant with blood collection organized in the surgical bed of a closed wound in the 30 days after surgery |
| Rate of Lymphorrhagia | 30 days | Number of participant with discharge of clear fluid through a surgical wound in the 30 days after surgery |
| Surgical Wound Complications Rate | 30 days | Number of participant with surgical wound complications according to medical criteria of any of the following signs: * Seroma or lymphocele * Surgical wound dehiscence * Hematoma * Lymphorrhagia To be measured in 30 days. |
| Postoperative mortality Rate | 30 days | Rate of death in the 30 days after surgery |
| Surgical wound infection-related mortality Rate | 30 days | Rate of mortality secondary to infection of the surgical wound or due to causes related to complications of the inguinal surgical wound. |
| Level of postoperative pain | 7 days | Measurement of postoperative pain in the 7 days after surgery. Carried out using the visual analog scale (VAS) applied to the patient |
| Extended hospital admission rate | 30 days | Number of participant with prolonged admission of more than 14 days due to cause/s related to the inguinal surgical wound complications or the need for reoperation, as well as, hospital readmission due to problems related to the inguinal surgical wound |
Countries
Spain
Contacts
Primary ContactLaura M Rodriguez, MD
Backup ContactKerbi A Guevara Noriega, MD MSc PhD
Outcome results
None listed