Ostomy Primary Closure With 0.1% Betaine/Polyhexanide Wound Irrigation Compared to Pursestring Closure
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Nevada, Las Vegas
About this trial
The goal of this clinical trial is to compare two types of closure in patients with ostomies that are ready for closure. The main questions it aims to answer are:
1. Surgical site infection rates 2. Patient quality of life 3. Time to wound healing
Participants will undergo either complete ostomy wound closure after washing out the wound with Prontosan, or their ostomy wound will be closed using the Pursestring method, where the wound will be left partially open and allowed to heal from the inside out. Researchers will compare these two groups' outcomes (questions to be answered) as listed above.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All patients 18 years or older with an diverting loop ileostomy reversal indication will be enrolled
Signed consent
Disqualifiers
Under 18 years old, unable to provide consent, has a parastomal hernia requiring mesh repair, or has an end ileostomy
Trial design
Design model
Parallel
Treatments tested in this trial
Primary Ostomy Closure with 0.1% Betaine/0.1% Polyhexanide Wound Irrigation
DrugAn elliptical transverse incision will be made extending 1-2 cm lateral and medial to the mucocutaneous junction. The mobilization, anastomosis and fascial closure will be performed as in the pursestring closure group. The incision will then be irrigated using direct stream into the wound with 350cc of Prontosan. After one minute the wound will be suctioned dry. The subcutaneous fat will be mobilized and approximated with interrupted 2-0 Vicryl. The skin will be approximated with deep dermal 3-0 Vicryl and a running subcuticular 4-0 Monocryl suture and Dermabond will be applied.
Pursestring Closure
Procedure/SurgeryA circular incision will be made at the mucocutaneous junction of the ileostomy. After complete mobilization of the ileal limbs off the fascia and a stapled side to side functional end to end anastomosis, the fascia including the external and posterior rectus sheath will be closed with two running #0 PDS (Polydioxanone) suture. The wound will then be irrigated with saline and partially closed in the subcuticular plane with a 2-0 Monocryl suture in a pursestring fashion and packed in the middle with plain packing.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Primary Closure with 0.1% Betaine/0.1% Polyhexanide Wound IrrigationActive comparator 1 intervention
Group B: Secondary Closure with PursestringActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Surgical Site Infection Rates
Evaluate surgical site infection rates between the two treatment arms
Time frame
Evaluate surgical site for any signs of infection up to 30 days post-operatively.Secondary outcomes
1
Acceptability of wound or scar healing by patient
Evaluation of patient's perception of their ostomy wound or scar appearance using the Visual Analog Scale. The minimum value is 0, maximum value is 10, with the higher score meaning a worse outcome.
Time frame
Up to one year post-operatively.2
Amount of percepted wound care needed by patient
Evaluation of patient's perception of the amount of wound care needed during the healing of their ostomy wound using the Visual Analog Scale. The minimum value is "no wound care needed" and maximum value is "maximum amount of wound care needed", with "maximum amount of wound care needed" being the worst outcome.
Time frame
Up to 4 weeks after compete wound closure.3
Acceptability of wound and scar healing by patient
Evaluation of patient's perception of their ostomy wound and scar appearance using the Patient and Observer Scar Assessment Scale - Observer scale. The minimum value is 1 and maximum value is 10, with the higher score meaning a worse outcome.
Time frame
At 4 weeks post complete wound closure and at one year post-operatively.4
Wound healing
Time to wound-healing
Time frame
Until complete wound closure (estimated up to 4-6 weeks post-operation).Sponsors and contacts
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Source ClinicalTrials.gov