Pneumatic Tourniquet Application in Upper Extremity Surgeries

NCT06575088 | Completed

• 1 other identifier: 2022-12/5
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This study investigated the effect of cuff pressure and the selection of protective padding material(PPM) on the prevention of skin complications associated with pneumatic tourniquet(PT) application in upper extremity surgery. Methods: This randomized controlled trial was conducted between October 2022 and September 2023 at the Hand Surgery Clinic of XXX. Standard tourniquet pressure (STP) or limb occlusion pressure (LOP) was applied as PT cuff pressure. Cotton pads or elastic stockinette was used for PPM under the cuff. Patients were categorized into four groups; (i) STP with a cotton pad; (ii) STP with an elastic stockinette; (iii) LOP with a cotton pad; and (iv) LOP with an elastic stockinette. Total of 200 patients were included in the study, with 50 patients in each group. Skin complications were evaluated postoperatively at 0, 30, and 180 min.

Conditions

Skin Wound; Complication of Surgical Procedure

Keywords

Skin Complications; Protective Material; Pneumatic Tourniquet; Tourniquet Pressure; Upper Extremity Surgery

Outcome Measures

Primary Outcomes (4)

• Redness

  Redness was defined as a reddish appearance on the skin, in contrast to a normal skin appearance.

  through study completion, an average of 1 year

• Tourniquet scar

  A tourniquet scar is a scar on the skin in the form of wrinkles and folds aligned with the structure of the sleeve.

  through study completion, an average of 1 year

• Petechiae

  Petechiae was defined as the occurrence of pinpoint-sized hemorrhages under the skin of the sleeve.

  through study completion, an average of 1 year

• Bulla

  A bulla is considered a fluid-filled blister on the skin.

  through study completion, an average of 1 year

Study Arms (4)

Standard tourniquet pressure with cotton pad

ACTIVE COMPARATOR

Cotton pad was applied as protective filling material. Standard 250 mmHg pressure was applied as pneumatic tourniquet pressure.

Other: Standard tourniquet pressure (250 mmHg); Other: Cotton Pad

Standard tourniquet pressure with elastic stockinette

ACTIVE COMPARATOR

Elastic stockinette was applied as protective filling material. Standard 250 mmHg pressure was applied as pneumatic tourniquet pressure.

Other: Standard tourniquet pressure (250 mmHg); Other: Elastic stockinette

Limb occlusion pressure with cotton pad

ACTIVE COMPARATOR

Cotton pad was applied as protective filling material. Limb occlusion pressure was applied as pneumatic tourniquet pressure.

Other: Limb occlusion pressure; Other: Cotton Pad

Limb occlusion pressure with elastic stockinette

ACTIVE COMPARATOR

Elastic stockinette was applied as protective filling material. Limb occlusion pressure was applied as pneumatic tourniquet pressure.

Other: Limb occlusion pressure; Other: Elastic stockinette

Interventions

Standard tourniquet pressure (250 mmHg) OTHER

The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.

Standard tourniquet pressure with cotton pad; Standard tourniquet pressure with elastic stockinette

Limb occlusion pressure OTHER

The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.

Limb occlusion pressure with cotton pad; Limb occlusion pressure with elastic stockinette

Cotton Pad OTHER

The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.

Limb occlusion pressure with cotton pad; Standard tourniquet pressure with cotton pad

Elastic stockinette OTHER

The effectiveness of the protective padding material placed on the skin with a pneumatic tourniquet cuff and the pneumatic tourniquet pressure determination methods were compared.

Limb occlusion pressure with elastic stockinette; Standard tourniquet pressure with elastic stockinette

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who 18 years and older
• Patients who undergoing upper extremity surgery
• Patients who underwent surgery under general and regional anesthesia
• Patients who having no communication problems
• Patients who agreeing to participate in the study

You may not qualify if:

• Patients who with communication barriers
• Patients who refused to participate in the study
• Patients who aged below 18 years
• Patients who underwent surgery for the second time
• Patients who underwent bilateral extremity surgery
• Patients without pneumatic tourniquet application
• Patients who received hypertension treatment
• Patients who diabetes mellitus treatment
• Patients who had skin lesions under the cuff during preoperative observation
• Patients who had active infection
• Patients who had skin complications
• Patients who have an above-elbow splint applied
• Patients who underwent surgical operation associated with malignancy
• Patients with the surgical area located proximal to the elbow

Sponsors & Collaborators

• Bursa City Hospital: lead

Study Sites (1)

Republic of Turkey Ministry of Health Bursa City Hospital

Bursa, Turkey (Türkiye)

Location

Related Publications (32)

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  BACKGROUND

Study Officials

• Sevgi Vermisli Ciftci, Ph.D.

  Republic of Turkey Ministry of Health Bursa City Hospital/Operating Room

  STUDY CHAIR

• Zeki Gunsoy, M.D.

  Republic of Turkey Ministry of Health Bursa City Hospital/Hand Surgery Clinic

  PRINCIPAL INVESTIGATOR

• Fatma Demir Korkmaz, Professor

  Ege University/ Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients were categorized into four groups based on the method of choice for determining the level of tourniquet cuff pressure and the PPM applied under the cuff. (i) . Standard tourniquet pressure (STP) with cotton pad; (ii) STP with elastic stockinette; (iii) limb occlusion pressure (LOP) with cotton pad; and finally, LOP with elastic stockinette. Power analysis was performed using the PASS software for sample size calculation. 50 patients were included in each group, considering that some patients might discontinue the trial. Block randomization method was used to randomize patients into study groups. The independent variables of the study were skin complications associated with tourniquet application on the skin under the sleeve. Complications were identified by the study team and confirmed by clinic nurses, and there was no disagreement regarding the occurrence of complications.

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 28, 2024
• Study Start: October 14, 2022
• Primary Completion: July 30, 2023
• Study Completion: September 29, 2023
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

TU (1)