Comparison of Wound Healing Duration Between Vacuum-Assisted Closure (VAC) and Conventional Dressings

ConditionWound Healing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-60
SponsorJinnah Postgraduate Medical Centre

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Vacuum-Assisted Closure (VAC) Therapy Description:

    Device

    The 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 intervention

    Saline-soaked dressing will be placed over the wound and bandage applied, with dressing changes every 24 hours

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: VAC TherapyExperimental treatment 1 intervention
Group B: Conventional DressingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From initiation of treatment until complete wound healing, up to 2 weeks.

Secondary outcomes

1

Wound Infection

Frequency of wound infection during the treatment period, based on predefined clinical criteria.

Time frame
From initiation of treatment until completion of the 2-week follow-up period.
2

Length of Hospital Stay

Number of days from hospital admission until discharge.

Time frame
During the index hospital admission.
3

Need for Additional Surgical Intervention

Proportion of participants requiring additional surgical intervention for wound management during the study period.

Time frame
From initiation of treatment until completion of the 2-week follow-up period.

Other outcomes

Sponsors and contacts

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