About this trial
This randomized controlled trial will compare vacuum-assisted closure (VAC) therapy with conventional wound dressings for the treatment of open contaminated and dirty wounds. The study will be conducted in the Department of General Surgery, Jinnah Postgraduate Medical Centre (JPMC), Karachi. Eligible patients aged 15 to 60 years with open contaminated or dirty wounds measuring 5-10 cm and classified as American Society of Anesthesiologists (ASA) grade I or II will be randomly allocated to either VAC therapy or conventional dressings. The primary outcome will be mean duration of wound healing, measured in days from initiation of the assigned treatment until complete wound healing according to predefined clinical criteria. The study will compare the duration of wound healing between the two treatment groups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients having open contaminated and dirty wounds of size 5 - 10cm as per operational definition.
Patients between ages 15 to 60 years.
Both gender
ASA grade I & II
Disqualifiers
Patients with wounds having dry eschar, malignancy in wound, untreated osteomyelitis, exposed blood vessels and organs, long term anticoagulant therapy, bleeding disorders and fistula to organ / body cavities. Dermatological disorders like acute dermatitis, fungal infections of perianal region.
All the patients presented with exposed bone, tendons or nerve will be excluded from study
Pregnant women.
Patients on medications, such as corticosteroids, immunosuppressive agents or chemotherapy. All above will be assessed on history and documented medical history.
Trial design
Parallel
Treatments tested in this trial
Vacuum-Assisted Closure (VAC) Therapy Description:
DeviceThe wound will be covered with polyurethane foam and a multi-hole drain will be placed over it. The dressing will be sealed with an airtight dressing and connected to a negative-pressure system providing intermittent negative pressure of 125 mmHg, with 45 minutes ON and 15 minutes OFF cycles. VAC dressing changes will be performed every 48-72 hours.
Conventional Wound Dressing
Other interventionSaline-soaked dressing will be placed over the wound and bandage applied, with dressing changes every 24 hours
Treatment groups
Trial outcomes
Primary outcomes
Duration of Wound Healing
Duration of wound healing, measured in days from initiation of the assigned treatment until complete wound healing according to the predefined clinical criteria. The mean duration in days will be compared between the VAC therapy and conventional dressing groups.
Secondary outcomes
Wound Infection
Frequency of wound infection during the treatment period, based on predefined clinical criteria.
Length of Hospital Stay
Number of days from hospital admission until discharge.
Need for Additional Surgical Intervention
Proportion of participants requiring additional surgical intervention for wound management during the study period.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: